NCT02330848
Completed
Not Applicable
Walnut Ingestion in Adults at Risk for Diabetes: Effects on Body Composition, Diet Quality, and Cardiac Risk Measures
ConditionsDiabetes
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Griffin Hospital
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Diet Quality assessed using the Alternative Healthy Eating Index (AHEI)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Body Composition measured using bioelectrical impedance analysis and SC-240 Body Composition Analyzer(6 months)
- Endothelial Function (EF) Assessment using the brachial artery reactivity studies (BARS) methodology(6 months)
- Anthropometric Measures(6 months)
- Lipid Profile(6 months)
- Fasting Blood Glucose(6 months)
- HbA1C(6 months)
- Physical Activity assessed by the International Physical Activity Questionnaire (IPAQ)(6 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)Type 2 DiabetesChronic Kidney DiseaseNCT01621178Eli Lilly and Company577
Completed
Not Applicable
What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)Time-restricted EatingDiet QualityNCT04762251University of Adelaide247
Completed
Not Applicable
Effects of Daily Walnut Intake Among the Subjects With Metabolic SyndromeMetabolic SyndromeNCT03267901ICAN Nutrition Education and Research119
Completed
Phase 2
Almond Butter and Fasting GlucoseType2 DiabetesNCT03826472Penn State University10
Completed
Phase 3
The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic PatientsDietary SupplementsNCT04552002Imam Abdulrahman Bin Faisal University64