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Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01260272
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : November 1, 2012
Last Update Posted : April 29, 2014
Sponsor:
Collaborator:
California Raisin Marketing Board
Information provided by (Responsible Party):
Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cardiovascular Risk Factors
Interventions Other: Alternative Snack Comparator
Other: Raisins
Enrollment 49
Recruitment Details Recruitment for this study started around Dec 2010 and ended around April 2011. Subjects were selected from the PI's contact database and from advertisements
Pre-assignment Details Subjects completed a 2-4 week screening period, during which labs and medical records were reviewed to verify eligibility
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Period Title: Overall Study
Started 17 32
Completed 15 30
Not Completed 2 2
Arm/Group Title Alternative Snack Group Raisin Group Total
Hide Arm/Group Description

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Total of all reporting groups
Overall Number of Baseline Participants 17 32 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 32 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  76.5%
20
  62.5%
33
  67.3%
>=65 years
4
  23.5%
12
  37.5%
16
  32.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 32 participants 49 participants
61.1  (1) 60.3  (1) 60.57  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 32 participants 49 participants
Female
6
  35.3%
19
  59.4%
25
  51.0%
Male
11
  64.7%
13
  40.6%
24
  49.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 32 participants 49 participants
17 32 49
1.Primary Outcome
Title Percent Change in Postprandial Glucose Levels
Hide Description Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 15 28
Mean (Standard Error)
Unit of Measure: Percent change from baseline
6.34  (7.4) -9.83  (3.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.033
Comments Apriori threshold for statistical significance was <=0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Percent Change in Fasting Glucose Levels
Hide Description Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 14 31
Median (95% Confidence Interval)
Unit of Measure: Percent change from baseline
1.5
(-2.0 to 3.0)
1.0
(-2.88 to 7.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.7498
Comments Apriori threshold for statistical significance was <=0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Percent Change in Body Weight
Hide Description Raisin versus snacks: percent change in body weight from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 14 31
Mean (Standard Error)
Unit of Measure: Percent change from baseline
-0.67  (0.47) 0.16  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.2615
Comments Apriori threshold for statistical significance was <=0.05
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Raisin versus snacks: change in systolic blood pressure from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 14 30
Mean (Standard Error)
Unit of Measure: mmHg
1.71  (2.43) -4.83  (1.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0468
Comments Apriori threshold for statistical significance was <=0.05
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Diastolic Blood Pressure
Hide Description Raisin versus snacks: change in diastolic blood pressure from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 15 31
Mean (Standard Error)
Unit of Measure: mmHg
-1.87  (2.14) -5.16  (1.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.2114
Comments Apriori threshold for statistical significance was <=0.05
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Hemoglobin A1c
Hide Description Raisin versus snacks: change in hemoglobin A1c from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 14 30
Mean (Standard Error)
Unit of Measure: Percent change from baseline
-.04  (0.04) -0.12  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.1727
Comments Apriori threshold for statistical significance was <=0.05
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change in Waist Circumference
Hide Description Raisin versus snacks: change in waist circumference from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 14 29
Mean (Standard Error)
Unit of Measure: cm
-1.59  (0.52) -2.02  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.6915
Comments Apriori threshold for statistical significance was <=0.05
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change in High Density Lipoprotein Cholesterol Levels
Hide Description Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description:

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

Overall Number of Participants Analyzed 13 30
Mean (Standard Error)
Unit of Measure: Percent change from baseline
0.62  (3.15) -5.63  (2.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alternative Snack Group, Raisin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1060
Comments Apriori threshold for statistical significance was <=0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events were collected from the day the subject signed the Informed Consent Document, until 30 days after study completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alternative Snack Group Raisin Group
Hide Arm/Group Description

This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables

Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers

This group will receive raisins to consume three times a day with meals

Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.

All-Cause Mortality
Alternative Snack Group Raisin Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alternative Snack Group Raisin Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Alternative Snack Group Raisin Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/17 (29.41%)      20/32 (62.50%)    
Cardiac disorders     
Worsening hypertension   1/17 (5.88%)  1 1/32 (3.13%)  1
Endocrine disorders     
Diabetes Mellitus   0/17 (0.00%)  0 1/32 (3.13%)  1
Gastrointestinal disorders     
Excess Gas   0/17 (0.00%)  0 1/32 (3.13%)  1
Increased frequency of stools   0/17 (0.00%)  0 1/32 (3.13%)  1
Indigestion   0/17 (0.00%)  0 1/32 (3.13%)  1
Constipation   0/17 (0.00%)  0 1/32 (3.13%)  1
Diarrhea   2/17 (11.76%)  2 2/32 (6.25%)  2
Nausea   0/17 (0.00%)  0 2/32 (6.25%)  2
Abdominal Pain   0/17 (0.00%)  0 2/32 (6.25%)  2
Worsening heartburn   0/17 (0.00%)  0 1/32 (3.13%)  1
Xerostomia   0/17 (0.00%)  0 1/32 (3.13%)  1
General disorders     
Allergic Rhinitis   0/17 (0.00%)  0 1/32 (3.13%)  1
Fluid retention   0/17 (0.00%)  0 1/32 (3.13%)  1
Flu-like symptoms   0/17 (0.00%)  0 1/32 (3.13%)  1
Vertigo   0/17 (0.00%)  0 1/32 (3.13%)  1
Pyrexia   1/17 (5.88%)  1 0/32 (0.00%)  0
Hepatobiliary disorders     
Elevated liver enzymes   0/17 (0.00%)  0 1/32 (3.13%)  1
Infections and infestations     
Sinusitis   0/17 (0.00%)  0 2/32 (6.25%)  2
Injury, poisoning and procedural complications     
Puncture wound  [1]  1/17 (5.88%)  1 0/32 (0.00%)  0
Posterior head pain related to trauma   0/17 (0.00%)  0 1/32 (3.13%)  1
Metabolism and nutrition disorders     
Decreased hunger   0/17 (0.00%)  0 1/32 (3.13%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasm   1/17 (5.88%)  1 0/32 (0.00%)  0
Left ankle pain   0/17 (0.00%)  0 1/32 (3.13%)  2
Strained muscle   0/17 (0.00%)  0 1/32 (3.13%)  1
Effusion to right elbow   0/17 (0.00%)  0 1/32 (3.13%)  1
Costochondritis   0/17 (0.00%)  0 1/32 (3.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign uterine mass   0/17 (0.00%)  0 1/32 (3.13%)  1
Renal and urinary disorders     
Bladder infection   0/17 (0.00%)  0 1/32 (3.13%)  1
Reproductive system and breast disorders     
Intermittent cough   1/17 (5.88%)  1 0/32 (0.00%)  0
Chest congestion   1/17 (5.88%)  1 0/32 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection   0/17 (0.00%)  0 4/32 (12.50%)  4
Bronchitis   0/17 (0.00%)  0 1/32 (3.13%)  1
Skin and subcutaneous tissue disorders     
Contact dermatitis   0/17 (0.00%)  0 2/32 (6.25%)  2
Contusion   1/17 (5.88%)  1 0/32 (0.00%)  0
Vascular disorders     
Brain hemorrhage   0/17 (0.00%)  0 1/32 (3.13%)  1
Indicates events were collected by systematic assessment
[1]
injury- not related to study
This was a single research site pilot study, which would benefit from a larger study, or at least, a similar confirmatory study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kathy Schmitz, Site Manager
Organization: L-MARC Research center
Phone: 502 214 3990
Responsible Party: Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center
ClinicalTrials.gov Identifier: NCT01260272     History of Changes
Other Study ID Numbers: 001
First Submitted: December 13, 2010
First Posted: December 15, 2010
Results First Submitted: August 29, 2012
Results First Posted: November 1, 2012
Last Update Posted: April 29, 2014