Cardiovascular Risk Factors
Conditions
Keywords
Cardiovascular, Risk Factors, Cardiovascular Disease, Glucose, Blood Pressure, BMI, Weight, Waist Circumference
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.
Interventions
OTHERAlternative 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
OTHERRaisins
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.
Sponsors
California Raisin Marketing Board
Louisville Metabolic and Atherosclerosis Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Postprandial Glucose Levels | 12 weeks | Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12 |
| Percent Change in Fasting Glucose Levels | 12 weeks | Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12 |
| Percent Change in Body Weight | 12 weeks | Raisin versus snacks: percent change in body weight from baseline to week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | 12 weeks | Raisin versus snacks: change in waist circumference from baseline to week 12 |
| Change in Systolic Blood Pressure | 12 weeks | Raisin versus snacks: change in systolic blood pressure from baseline to week 12 |
| Change in High Density Lipoprotein Cholesterol Levels | 12 weeks | Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12 |
| Change in Diastolic Blood Pressure | 12 weeks | Raisin versus snacks: change in diastolic blood pressure from baseline to week 12 |
| Change in Hemoglobin A1c | 12 weeks | Raisin versus snacks: change in hemoglobin A1c from baseline to week 12 |
Countries
United States
Participant flow
Recruitment details
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
Subjects completed a 2-4 week screening period, during which labs and medical records were reviewed to verify eligibility
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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. | 32 |
| Total | 49 |
Baseline characteristics
| Characteristic | Raisin Group | Alternative Snack Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 4 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 13 Participants | 33 Participants |
| Age, Continuous | 60.3 years STANDARD_DEVIATION 1 | 61.1 years STANDARD_DEVIATION 1 | 60.57 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 32 participants | 17 participants | 49 participants |
| Sex: Female, Male Female | 19 Participants | 6 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 17 | 20 / 32 |
| serious Total, serious adverse events | 0 / 17 | 0 / 32 |
Outcome results
Primary
Percent Change in Body Weight
Raisin versus snacks: percent change in body weight from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative Snack Group | Percent Change in Body Weight | -0.67 Percent change from baseline | Standard Error 0.47 |
| Raisin Group | Percent Change in Body Weight | 0.16 Percent change from baseline | Standard Error 0.44 |
p-value: =0.2615t-test, 2 sided
Primary
Percent Change in Fasting Glucose Levels
Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Alternative Snack Group | Percent Change in Fasting Glucose Levels | 1.5 Percent change from baseline |
| Raisin Group | Percent Change in Fasting Glucose Levels | 1.0 Percent change from baseline |
p-value: =0.7498Wilcoxon (Mann-Whitney)
Primary
Percent Change in Postprandial Glucose Levels
Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative Snack Group | Percent Change in Postprandial Glucose Levels | 6.34 Percent change from baseline | Standard Error 7.4 |
| Raisin Group | Percent Change in Postprandial Glucose Levels | -9.83 Percent change from baseline | Standard Error 3.64 |
p-value: =0.033t-test, 2 sided
Secondary
Change in Diastolic Blood Pressure
Raisin versus snacks: change in diastolic blood pressure from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative Snack Group | Change in Diastolic Blood Pressure | -1.87 mmHg | Standard Error 2.14 |
| Raisin Group | Change in Diastolic Blood Pressure | -5.16 mmHg | Standard Error 1.48 |
p-value: =0.2114t-test, 2 sided
Secondary
Change in Hemoglobin A1c
Raisin versus snacks: change in hemoglobin A1c from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative Snack Group | Change in Hemoglobin A1c | -.04 Percent change from baseline | Standard Error 0.04 |
| Raisin Group | Change in Hemoglobin A1c | -0.12 Percent change from baseline | Standard Error 0.04 |
p-value: =0.1727t-test, 2 sided
Secondary
Change in High Density Lipoprotein Cholesterol Levels
Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative Snack Group | Change in High Density Lipoprotein Cholesterol Levels | 0.62 Percent change from baseline | Standard Error 3.15 |
| Raisin Group | Change in High Density Lipoprotein Cholesterol Levels | -5.63 Percent change from baseline | Standard Error 2.08 |
p-value: 0.106t-test, 2 sided
Secondary
Change in Systolic Blood Pressure
Raisin versus snacks: change in systolic blood pressure from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative Snack Group | Change in Systolic Blood Pressure | 1.71 mmHg | Standard Error 2.43 |
| Raisin Group | Change in Systolic Blood Pressure | -4.83 mmHg | Standard Error 1.86 |
p-value: =0.0468t-test, 2 sided
Secondary
Change in Waist Circumference
Raisin versus snacks: change in waist circumference from baseline to week 12
Time frame: 12 weeks
Population: Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alternative Snack Group | Change in Waist Circumference | -1.59 cm | Standard Error 0.52 |
| Raisin Group | Change in Waist Circumference | -2.02 cm | Standard Error 0.7 |
p-value: =0.6915t-test, 2 sided