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

This study has been completed.
Sponsor:
Collaborator:
California Raisin Marketing Board
Information provided by (Responsible Party):
Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center
ClinicalTrials.gov Identifier:
NCT01260272
First received: December 13, 2010
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
Results First Received: August 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Cardiovascular Risk Factors
Interventions: Other: Alternative Snack Comparator
Other: Raisins

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects completed a 2-4 week screening period, during which labs and medical records were reviewed to verify eligibility

Reporting Groups
  Description
Alternative Snack Group

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
Raisin Group

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.

Participant Flow:   Overall Study
    Alternative Snack Group     Raisin Group  
STARTED     17     32  
COMPLETED     15     30  
NOT COMPLETED     2     2  



  Baseline Characteristics
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Reporting Groups
  Description
Alternative Snack Group

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
Raisin Group

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 Total of all reporting groups

Baseline Measures
    Alternative Snack Group     Raisin Group     Total  
Number of Participants  
[units: participants]
 		  17     32     49  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     13     20     33  
>=65 years     4     12     16  
Age  
[units: years]
Mean ± Standard Deviation 		  61.1  ± 1     60.3  ± 1     60.57  ± 1  
Gender  
[units: participants]
 		     
Female     6     19     25  
Male     11     13     24  
Region of Enrollment  
[units: participants]
 		     
United States     17     32     49  



  Outcome Measures
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1.  Primary:   Postprandial Glucose Levels After 3 Months of Raisins vs Alternative Snacks, Consumed 3 Times Daily   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Primary:   Body Weight After 3 Months of Raisins vs Alternative Snacks, Consumed 3 Times Daily   [ Time Frame: 12 weeks ]
  Show Outcome Measure 2

3.  Secondary:   High Density Lipoprotein Levels After 3 Months of Raisins vs Alternative Snacks, Consumed 3 Times Daily   [ Time Frame: 12 weeks ]
  Show Outcome Measure 3

4.  Secondary:   HbA1c Levels After 3 Months of Raisins vs Alternative Snacks, Consumed 3 Times Daily.   [ Time Frame: 12 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Systolic Blood Pressure Levels After 3 Months of Raisins vs Alternative Snacks, Consumed 3 Times Daily.   [ Time Frame: 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Diastolic Blood Pressure Levels After 3 Months of Raisins vs Alternative Snacks, Consumed 3 Times Daily.   [ Time Frame: 12 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Waist Cirumference After 3 Months of Raisins vs Alternative Snacks, Consumed 3 Times Daily.   [ Time Frame: 12 weeks ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Kathy Schmitz, Site Manager
Organization: L-MARC Research center
phone: 502 214 3990
e-mail: kschmitz@lmarc.com


No publications provided


Responsible Party: Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center
ClinicalTrials.gov Identifier: NCT01260272     History of Changes
Other Study ID Numbers: 001
Study First Received: December 13, 2010
Results First Received: August 29, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board