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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

  Participant Flow

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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

1.  Primary:   Percent Change in Postprandial Glucose Levels   [ Time Frame: 12 weeks ]

2.  Primary:   Percent Change in Fasting Glucose Levels   [ Time Frame: 12 weeks ]

3.  Primary:   Percent Change in Body Weight   [ Time Frame: 12 weeks ]

4.  Secondary:   Change in Systolic Blood Pressure   [ Time Frame: 12 weeks ]

5.  Secondary:   Change in Diastolic Blood Pressure   [ Time Frame: 12 weeks ]

6.  Secondary:   Change in Hemoglobin A1c   [ Time Frame: 12 weeks ]

7.  Secondary:   Change in Waist Circumference   [ Time Frame: 12 weeks ]

8.  Secondary:   Change in High Density Lipoprotein Cholesterol Levels   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
This was a single research site pilot study, which would benefit from a larger study, or at least, a similar confirmatory study.


  More Information

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
e-mail: kschmitz@lmarc.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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