Glucose Intolerance Clinical Trial
Official title:
Effects of Almonds on Glycemia in Adults With Elevated Hemoglobin A1c Concentrations
Verified date | December 2023 |
Source | Purdue University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control.
Status | Active, not recruiting |
Enrollment | 84 |
Est. completion date | May 30, 2024 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - HbA1c >5.7% - BMI >20 kg/M^2 - Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same level for the duration of the trial. - Healthy, good dentition - No nut allergies - >4.0 eating events per day - >=1 low nutrient density snack/d - No allergy to chocolate Exclusion Criteria: - HbA1c within normal range - BMI <20 kg/M^2 - Nut allergies - Smoker - Pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Purdue Univeristy | West Lafayette | Indiana |
Lead Sponsor | Collaborator |
---|---|
Purdue University | Almond Board of California |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compliance - Vitamin E | mg/L | Baseline, week 8 and week 16. | |
Other | Compliance - fatty acid profile | % fatty acid composition | Baseline, week 8 and week 16 | |
Primary | HbA1c | Baseline | ||
Primary | Change in HbA1c | HbA1c % change | 16 weeks | |
Secondary | Glucose response to a meal tolerance test | mg/dl | Baseline and week 16 | |
Secondary | Insulin response to a meal tolerance test | mmol/L | Baseline and week 16 | |
Secondary | Chronic glycemia | mg/dl | Baseline, week 8 and week 16 | |
Secondary | Food intake | kcal | Two days (one week day and one weekend day) at screening, week 8 and week 16. | |
Secondary | Body weight | Kilograms (kg) | Screening, baseline, week 4, week 8, week 12, and week 16 | |
Secondary | Body composition | Percentage (%) | Baseline, week 16 | |
Secondary | Hedonic survey | mm on a VAS | Baseline, week 4, week 8, week 12. week 16 |
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