Clinical trial NCT01260272: Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
Official title: A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Keywords: Cardiovascular
Risk Factors
Cardiovascular Disease
Glucose
Blood Pressure
BMI
Weight
Waist Circumference
Lead sponsor: Louisville Metabolic and Atherosclerosis Research Center
Sponsor class: OTHER
Collaborators: name: California Raisin Marketing Board
First posted: 2010-12-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Are generally healthy men and women older than 18 years of age.
2. Are willing and able to undergo the informed consent process.
3. Have body mass index (BMI) from 25.0 to 34.9 kg/m².
4. 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.
5. Have blood pressure \> 120 mmHg systolic or \> 80 mmHg diastolic.
6. Are willing to notify the research staff of any change in their medical health \& concomitant medications/supplements during the course of the clinical trial.

Exclusion Criteria:

1. Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.
2. History of \> one "food allergy."
3. Weight loss of \> 5 pounds in last 2 months
4. 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.
5. Blood pressure \>160 mmHg systolic or \>100 mmHg diastolic.
6. Fasting serum lipoprotein values of: LDL-cholesterol, \>160 mg/dl or triglycerides, \>500 mg/dl.
7. Creatinine level \> 1.5 times the upper range of normal.
8. 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)
9. Use of any medication or supplement to treat diabetes mellitus or blood glucose management at, or within 2 months prior to initial study entry.
10. 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.
11. 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.
12. Is pregnant, breastfeeding or plans to become pregnant during the next three months.
13. Is an employee or immediate family member of the research staff.
14. Donated blood within 2 months prior to study entry, or plans to donate blood during the course of this study.
15. Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled and intranasal corticosteroids are permitted.
16. Use of antiobesity/weight maintenance drug therapies at initial study visit, or within 2 months of the initial study visit.
17. Known medical history of clinical significance, or any other conditions that would present unacceptable risk to study subject, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study as per discretion of the Principal Investigator.
18. History of severe or uncontrolled depression based on Principal Investigator.
19. Known laboratory abnormalities prior to randomization which Principal Investigator deems may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.
20. Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures.
21. History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery. Gastric banding procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day of signing the informed consent document), or a reasonable chance of having a gastric banding adjustment during the course of the study.
22. History of ongoing malignancy. Malignancy that has been successfully treated, with no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document) or basal carcinoma of the skin and "in situ" cancer of the cervix successfully treated 30 days prior to visit #1 are acceptable.
23. History of organ transplant.
24. History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).
25. Consumes more than 2 units of alcohol per day. A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof alcohol for mixed drinks.
26. Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active hepatitis A immunoglobulin M, or human immunodeficiency virus.
27. Anticipation of a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.
28. Anticipation of or a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.
29. Anticipation of or a reasonable likelihood of vacations or other times away from home which might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.
30. Planned or anticipated major changes in lifestyle health practices, unless allowed by study protocol. Therapeutic Lifestyle Changes counseling will take place at randomization.
31. Treatment with an investigational product or an investigational device within 30 days prior to visit #1 (i.e. day of signing the informed consent document) and have no plans to potentially start any investigational product or use an investigational device during or 30 days after the study subject completes all study related procedures.
32. Reasonable life-expectancy of less than 2 years.
33. Any other reason, if in the opinion of the Investigator, the individual study subject is not appropriate, or suitable for participation in the clinical trial.

Primary outcomes:
measure: Percent Change in Postprandial Glucose Levels
timeFrame: 12 weeks
measure: Percent Change in Fasting Glucose Levels
timeFrame: 12 weeks
measure: Percent Change in Body Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: 12 weeks
measure: Change in Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Change in Hemoglobin A1c
timeFrame: 12 weeks
measure: Change in Waist Circumference
timeFrame: 12 weeks
measure: Change in High Density Lipoprotein Cholesterol Levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Louisville Metabolic and Atherosclerosis Research Center
state: Kentucky
Study officials:
affiliation: Louisville Metabolic and Atherosclerosis Research Center
name: Harold E. Bays, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.