Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures
Completed · Not applicable
Conditions studied: Diabetes
In brief
Proposed is a randomized, controlled, modified Latin square parallel design study with two treatment arms to examine walnut consumption effects on diet quality, body composition, and markers of cardiovascular risk in adults at risk for diabetes over a 6-month period. A modified crossover design (Latin square)27-29 will allow for both paired and unpaired analyses.
Key facts
- Study ID
- NCT02330848
- Run by
- Griffin Hospital
- People needed
- 112
- Starts
- 2012-02-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2020-03-26
Who can join
Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female age 25-75 years;
- Non-smoker;
- High risk for diabetes, defined as meeting at least one of the criteria listed below:
- a. Overweight with increased waist circumference; b.Pre-diabetes: fasting blood glucose >100mg/dL and <126mg/dL or HbA1C 5.7-6.4 % c. Metabolic syndrome, i.e. meet three out of five of the following criteria: i.Blood pressure >130/85 mmHg or currently taking antihypertensive medication; ii. Fasting plasma glucose (FPG) >100 mg/dL (6.1 mmol/L); iii.Serum triglycerides level (TG)>150 mg/dL (1.69 mmol/L); iv. High-density lipoprotein (HDL) cholesterol < 40 mg/dL (1.04 mmol/L) in men, and < 50 mg/dL (1.29 mmol/L) in women; v. Overweight (BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women.
You may not qualify if…
- Allergy to walnuts or any other nuts;
- Anticipated inability to complete study protocol for any reason;
- Current eating disorder;
- Restricted diets by choice (i.e., vegetarian, vegan);
- Receiving pharmacotherapy for obesity, including appetite suppressant
- Unstable use of lipid-lowering, antihypertensive medications or aspirin (i.e. dose has changed in the three months prior to enrollment) or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning;
- Regular use of high doses of vitamin E (>400IU/day) or vitamin C (>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and fiber supplement unless welling to discontinue supplementation for the study duration.
- Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators);
- Diagnosed diabetes;
- Diagnosed sleep apnea;
- Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis);
- Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin;
- Regular exercise defined as participation in moderate-intensity exercise > 150 minutes/week.
- Substance abuse (chronic alcoholism, other chemical dependency)
- Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
- Women who get Depo-Provera shots
- Women who are pregnant or lactating
- Women who are currently on hormone replacement therapy
- Substance abuse (chronic alcoholism, other chemical dependency)
- Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
Where it is running
- Yale-Griffin Prevention Research Center — Derby, Connecticut, United States
Full record on ClinicalTrials.gov
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