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

September 16, 2024 updated by: West Virginia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

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

18 years to 28 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FRUVED
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
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.
Experimental: FRUVED + LRC
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
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.
Experimental: FRUVED + LF
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in metabolic parameters at 8 weeks
Time Frame: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
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
Time Frame: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
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
Time Frame: 8 weeks
calculation with body weight and height
8 weeks
Change in Blood pressure at 8 weeks
Time Frame: 8 weeks
Blood pressure, standard measurement equipment
8 weeks
Change in Arterial stiffness at 8 weeks
Time Frame: 8 weeks
Measured via dopler
8 weeks

Collaborators and Investigators

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

Sponsor

West Virginia University

Collaborators

University of Tennessee
University of New Hampshire

Investigators

  • Principal Investigator: Melissa D. Olfert, DrPH, RDN, West Virginia University

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.

General Publications

Helpful Links

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 (Actual)

January 15, 2015

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1409433435
  • 2014-67001-21851 (Other Grant/Funding Number: USDA National Institute of Food and Agriculure)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD at this time.

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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