NCT02330848

Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Griffin Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Specific Aims * To determine the effects of a walnut-included diet (with or without caloric intake adjustment) versus walnut-excluded diet on diet quality in adults at risk for diabetes. Specifically, to show that a walnut-included diet, as compared to a walnut-excluded diet will improve overall diet quality as measured by the Alternative Healthy Eating Index in adults at risk for diabetes. * To determine the effects of a walnut-included diet (with or without caloric intake adjustment) versus walnut-excluded diet on body composition in adults at risk for diabetes. Specifically, to show that a walnut-included diet, as compared to a walnut-excluded diet for 6 months will improve body fat percentage in adults at risk for diabetes. * To assess the effects of a walnut-included diet (with or without caloric intake adjustment) for a 6-month period on endothelial function, lipid panel levels, fasting glucose level, fasting insulin level and anthropometric measures in adults at risk for diabetes. Specifically, to show clinically meaningful improvement in endothelial function, lipid panel, fasting blood glucose, hemoglobin A1c (HbA1c), anthropometric measures and endothelial function with inclusion of walnuts in the diet in adults at risk for diabetes. Hypotheses * A walnut-included diet with or without dietary counseling to adjust caloric intake will improve diet quality in adults at risk for diabetes. * A walnut-included diet for 6 months with or without dietary counseling to adjust caloric intake will improve body composition in adults at risk for diabetes. * A walnut-included diet with or without dietary counseling to adjust caloric intake will improve lipid panel, fasting blood glucose, hemoglobin A1c, endothelial function and anthropometric measures in adults at risk for diabetes. * Controlling calorie intake to keep it constant with the addition of walnuts to the diet will enhance the beneficial effects of walnut ingestion on diet quality, body composition, and vascular function.

Conditions

• Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Walnut Ad libitum diet	Participants will be provided 392 grams of walnuts per week (56g or 2 oz/day) to include in their diet. Their calorie intake will not be subsequently monitored or regulated, and thus will be allowed to float ad libitum
DIETARY_SUPPLEMENT	Walnut Calorie controlled	The intervention group participants will meet with a registered dietitian and receive instructions and recipes for inclusion of 392 grams of walnuts per week (56g or 2 oz/day) in their meal plan for 6 months.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-09-01
• Completion: 2014-04-01
• First posted: 2015-01-05
• Last updated: 2020-03-26

Locations

1 site across 1 country: United States