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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
112
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
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.
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States
Diet Quality assessed using the Alternative Healthy Eating Index (AHEI)
To help the study team track any variation in dietary pattern over the course of the study, all participants will be asked at five different time points to provide information on the foods and beverages that they consumed. A 3-day food diary record will be collected along with a one 24-hour recall using a web-based Automated Self-Administered 24-Hour Recall (ASA24) (available from the National Cancer Institute at http://riskfactor.cancer.gov/tools/instruments/asa24/) which will guide them through the process of completing the recall data. Diet quality will be assessed using the Alternative Healthy Eating Index (AHEI).
Time frame: 6 months
Body Composition measured using bioelectrical impedance analysis and SC-240 Body Composition Analyzer
Body composition will be measured using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat. The Tanita SC-240 Body Composition Analyzer will be used to measure body composition. The SC-240 Body Composition Analyzer measures weight and calculates body fat% and total body water% in addition to BMI.
Time frame: 6 months
Endothelial Function (EF) Assessment using the brachial artery reactivity studies (BARS) methodology
The brachial artery reactivity studies (BARS) methodology employed is as described in the published, "Guidelines for Ultrasound Assessment of Endothelial-dependent Flow-mediated Vasodilation of the Brachial Artery." The measure of interest is flow-mediated dilatation of the brachial artery.
Time frame: 6 months
Anthropometric Measures
Body weight will be measured using a calibrated digital scale while height will be measured by using a calibrated stadiometer. Body mass index (BMI) will be calculated as weight (kg) divided by height in meters (m) squared. Waist circumference will be measured using guidelines of the National Obesity Expert Panel Report.
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Time frame: 6 months
Lipid Profile
The lipid profile is determined as follows: Total cholesterol (Tchol), triglycerides (TRIG), and high-density lipoprotein (HDL) are obtained by direct measurements. Very-low-density lipoprotein (VLDL) and low-density-lipoprotein (LDL) are obtained by calculation: VLDL = TRIG/5; and LDL = Tchol - (VLDL + HDL). HDL:Tchol ratio will be used to evaluate the impact of walnuts on the lipid profile.
Time frame: 6 months
Fasting Blood Glucose
Time frame: 6 months
HbA1C
Time frame: 6 months
Physical Activity assessed by the International Physical Activity Questionnaire (IPAQ)
Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ). The IPAQ is a valid and reliable tool to assess physical activity in adults. It is a more comprehensive tool containing information on weekly activities in household and yard-work activities, occupational activity, transport, leisure time physical activity and sedentary behavior.
Time frame: 6 months