FRUVEDomics: Behavioral Intervention in Young Adults to Identify Metabolomics and Microbiome Risk

Study Overview
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Brief Summary
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Rates of obesity and the metabolic syndrome are increasing in the young adult population (years 18-28). Modifying diet, especially increasing fruit and vegetable intake, can help assist in health maintenance and disease prevention. The purpose of this project is to evaluate the impact of the FRUVEDomics behavior intervention on dietary behaviors and metabolic parameters on young adults at-risk of disease. FRUVEDomics is an 8-week free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and driven by the Social Cognitive Theory, conducted in young adults (18-28 years old) at West Virginia University. Individuals were recruited if they had pre-existing poor nutritional habits. A metabolic syndrome risk screening score was given to participants at baseline to measure risk status for chronic disease. Subjects were randomized into one of three nutritional intervention groups: 1) FRUVED (50% fruit & vegetable), 2) FRUVED+LRC (50% fruit & vegetable plus low refined carbohydrate), and 3) FRUVED+LF (50% fruit & vegetable plus low fat). Anthropometrics, surveys, venous blood samples and body composition were collected before and after the intervention. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.

Detailed Description
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Background: Rates of obesity and the metabolic syndrome are increasing in the young adult population (years 18-28), further creating a need for interventions that will improve later quality of life. Modifying diet, especially increasing fruit and vegetable intake, can help assist in health maintenance and disease prevention. In the past decade, there has been considerable research on behavior interventions focusing on dietary change for the promotion of health. However, successful theory-based dietary behavioral interventions for young adults who follow poor lifestyle habits, are limited. The purpose of this paper is to evaluate the impact of the FRUVEDomics pilot study on dietary behaviors and metabolic parameters on young adults at-risk of disease. Methods: An 8-week free-living dietary intervention, based on the USDA Dietary Guidelines for Americans and driven by the Social Cognitive Theory, was conducted in young adults (18-28 years old) at West Virginia University. Individuals were recruited if they had pre-existing poor nutritional habits. A metabolic syndrome risk screening score was given to participants at baseline to measure risk status for chronic disease. Subjects (n=36) were randomized into one of three nutritional intervention groups; 1) FRUVED (50% fruit & vegetable), 2) FRUVED+LRC (50% fruit & vegetable plus low refined carbohydrate), and 3) FRUVED+LF (50% fruit & vegetable plus low fat). Anthropometrics, surveys, venous blood samples and body composition were collected before and after the intervention. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were successfully delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention. Specific Aim: Identify novel metabolomic and microbiome phenotypes in response to fruit and vegetable diet intervention in young adults with and without metabolic syndrome (MetS). Hypothesis 1: Diet consisting of 50% fruit & vegetable consumption (FRUVED diet) will improve metabolic health as evidenced by lower plasma concentrations of adipokines, inflammatory mediators, and ceramides. Hypothesis 2. Diet induced changes in the metabolome and micobiome will reveal novel phenotypes that have the potential to be used as new diagnostic biomarkers to distinguish between MetS and healthy adolescents.

Official Title
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FRUVEDomics Study: Use of a Behavioral Nutrition Intervention in Young Adults to Identify Modifiable Metabolomics and Microbiome Risk

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: FRUVEDomics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 28 years of age either showing evidence of metabolic syndrome or at risk for metabolic syndrome Exclusion Criteria: no evidence of metabolic syndrome or of being at-risk for metabolic syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 interventions evaluated against the other and a control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FRUVED<br>Individuals that are at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet with 50% fruit and vegetables. | Behavioral: FRUVEDomics<br>* FRUVEDomics is a behavioral nutrition intervention in young adults 'at risk for metS' and young adults 'with metS' to identify modifiable metabolomics and microbiome risk. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.<br>|
| Experimental: FRUVED + LRC<br>Individuals at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet of 50% fruit and vegetables plus low refined carbohydrates. | Behavioral: FRUVEDomics<br>* FRUVEDomics is a behavioral nutrition intervention in young adults 'at risk for metS' and young adults 'with metS' to identify modifiable metabolomics and microbiome risk. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.<br>|
| Experimental: FRUVED + LF<br>Individuals at risk for metS and those with metS went through an 8-week dietary intervention called FRUVEDomics to increase fruit and vegetable consumption measuring metabolome and microbiome markers with health-related behaviors. In this arm, individuals were assigned to a diet of 50% fruit and vegetables plus low fat. | Behavioral: FRUVEDomics<br>* FRUVEDomics is a behavioral nutrition intervention in young adults 'at risk for metS' and young adults 'with metS' to identify modifiable metabolomics and microbiome risk. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic parameters at 8 weeks | Metabolomic measures via blood sample | Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiome parameters at 8 weeks | Microbiome measures via stool sample | Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3) | 
| Change in Weight and BMI at 8 weeks | calculation with body weight and height | 8 weeks | 
| Change in Blood pressure at 8 weeks | Blood pressure, standard measurement equipment | 8 weeks | 
| Change in Arterial stiffness at 8 weeks | Measured via dopler | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Diet, Fruits and Vegetables, Metabolome, Microbiome, Young Adults