Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures (Walnut3)

March 25, 2020 updated by: Griffin Hospital
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Yale-Griffin Prevention Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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
Active Comparator: 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. Participants will receive on-going instruction to preserve an isocaloric condition after the addition of walnuts. The study dietitian will customize dietary adjustments to make room for walnuts in the diet, while accommodating the priorities of each study participant. The general approach will emphasize general reduction in portion sizes; participants will also receive advice, based on baseline dietary intake analysis, of food eliminations that they might want to consider.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet Quality assessed using the Alternative Healthy Eating Index (AHEI)
Time Frame: 6 months
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition measured using bioelectrical impedance analysis and SC-240 Body Composition Analyzer
Time Frame: 6 months
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.
6 months
Endothelial Function (EF) Assessment using the brachial artery reactivity studies (BARS) methodology
Time Frame: 6 months
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.
6 months
Anthropometric Measures
Time Frame: 6 months
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.
6 months
Lipid Profile
Time Frame: 6 months
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.
6 months
Fasting Blood Glucose
Time Frame: 6 months
6 months
HbA1C
Time Frame: 6 months
6 months
Physical Activity assessed by the International Physical Activity Questionnaire (IPAQ)
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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