N/A
N=49
Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
Cardiovascular Risk Factors
Bottom Line
View on ClinicalTrials.gov: NCT01260272 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Percent Change in Postprandial Glucose Levels — 6.34; -9.83 Percent change from baseline — p==0.033
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alternative Snack Comparator (Other); Raisins (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Louisville Metabolic and Atherosclerosis Research Center
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Postprandial Glucose Levels |
6.34; -9.83 | =0.033 sig |
| PRIMARY Percent Change in Fasting Glucose Levels |
1.5; 1.0 | =0.7498 |
| PRIMARY Percent Change in Body Weight |
-0.67; 0.16 | =0.2615 |
| SECONDARY Change in Systolic Blood Pressure |
1.71; -4.83 | =0.0468 sig |
| SECONDARY Change in Diastolic Blood Pressure |
-1.87; -5.16 | =0.2114 |
| SECONDARY Change in Hemoglobin A1c |
-.04; -0.12 | =0.1727 |
| SECONDARY Change in Waist Circumference |
-1.59; -2.02 | =0.6915 |
| SECONDARY Change in High Density Lipoprotein Cholesterol Levels |
0.62; -5.63 | 0.1060 |
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
- 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.
Exclusion Criteria
- 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.
- Use of antiobesity/weight maintenance drug therapies at initial study visit, or within 2 months of the initial study visit.
- 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.
- History of severe or uncontrolled depression based on Principal Investigator.
- 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.
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT01260272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.