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

NCT01260272 | Completed Results

• 1 other identifier: 001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This trial compared the effects of raisin intake on cardiovascular risk factors compared to common, commercially available, alternative snacks. These cardiovascular risk factors include glucose, blood pressure, lipid levels, body weight, and waist circumference.

Conditions

Cardiovascular Risk Factors

Keywords

Cardiovascular; Risk Factors; Cardiovascular Disease; Glucose; Blood Pressure; BMI; Weight; Waist Circumference

Outcome Measures

Primary Outcomes (3)

• Percent Change in Postprandial Glucose Levels

  Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12

  12 weeks

• Percent Change in Fasting Glucose Levels

  Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12

  12 weeks

• Percent Change in Body Weight

  Raisin versus snacks: percent change in body weight from baseline to week 12

  12 weeks

Secondary Outcomes (5)

• Change in Systolic Blood Pressure

  12 weeks

• Change in Diastolic Blood Pressure

  12 weeks

• Change in Hemoglobin A1c

  12 weeks

• Change in Waist Circumference

  12 weeks

• Change in High Density Lipoprotein Cholesterol Levels

  12 weeks

Study Arms (2)

Alternative Snack Group

ACTIVE COMPARATOR

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

Other: Alternative Snack Comparator

Raisin Group

EXPERIMENTAL

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

Other: Raisins

Interventions

Alternative Snack Comparator OTHER

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

Alternative Snack Group

Raisins OTHER

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.

Raisin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are generally healthy men and women older than 18 years of age.
• Are willing and able to undergo the informed consent process.
• Have body mass index (BMI) from 25.0 to 34.9 kg/m².
• Have one or more fasting plasma or serum glucose values of 90-150 mg/dl documented within 4 weeks of the initial study visit, or upon safety lab evaluation at the initial study visit.
• Have blood pressure \> 120 mmHg systolic or \> 80 mmHg diastolic.
• Are willing to notify the research staff of any change in their medical health \& concomitant medications/supplements during the course of the clinical trial.

You may not qualify if:

• Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.
• History of \> one "food allergy."
• Weight loss of \> 5 pounds in last 2 months
• Prior diagnosis of diabetes mellitus or currently taking diabetes mellitus drugs (including drugs such as metformin and colesevelam HCl, even if not being taken for diabetes mellitus). Subjects with prior history of gestational diabetes mellitus are eligible, as long as they no longer have diabetes mellitus, and are no longer taking medications for diabetes mellitus.
• Blood pressure \>160 mmHg systolic or \>100 mmHg diastolic.
• Fasting serum lipoprotein values of: LDL-cholesterol, \>160 mg/dl or triglycerides, \>500 mg/dl.
• Creatinine level \> 1.5 times the upper range of normal.
• Potassium level above the upper range of normal (one repeat lab would be permitted if the initial elevated potassium level is thought possibly due to laboratory error)
• Use of any medication or supplement to treat diabetes mellitus or blood glucose management at, or within 2 months prior to initial study entry.
• Initiation or change of any antihypertensive medication within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two antihypertensive medications that is/are to be maintained at constant dose throughout the study.
• Initiation or change of any lipid-altering drug within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two lipid-altering drugs that is/are to be maintained at constant dose throughout the study.
• Is pregnant, breastfeeding or plans to become pregnant during the next three months.
• Is an employee or immediate family member of the research staff.
• Donated blood within 2 months prior to study entry, or plans to donate blood during the course of this study.
• Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled and intranasal corticosteroids are permitted.

Sponsors & Collaborators

• Louisville Metabolic and Atherosclerosis Research Center: lead
• California Raisin Marketing Board: collaborator

Study Sites (1)

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky, 40213, United States

Location

Related Publications (1)

• Anderson JW, Weiter KM, Christian AL, Ritchey MB, Bays HE. Raisins compared with other snack effects on glycemia and blood pressure: a randomized, controlled trial. Postgrad Med. 2014 Jan;126(1):37-43. doi: 10.3810/pgm.2014.01.2723.

  PMID: 24393750 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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

Results Point of Contact

• Title: Kathy Schmitz, Site Manager
• Organization: L-MARC Research center

kschmitz@lmarc.com

502 214 3990

Study Officials

• Harold E. Bays, MD

  Louisville Metabolic and Atherosclerosis Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 29, 2014
• Results First Posted: November 1, 2012

Record last verified: 2014-04

Locations

US (1)