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

NCT03115866 | Completed

• 2 other identifiers: 14094334352014-67001-21851
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

Healthy Diet; Fruits and Vegetables; Metabolome; Microbiome; Young Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in microbiome parameters at 8 weeks

  Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)

• Change in Weight and BMI at 8 weeks

  8 weeks

• Change in Blood pressure at 8 weeks

  8 weeks

• Change in Arterial stiffness at 8 weeks

  8 weeks

Study Arms (3)

FRUVED

EXPERIMENTAL

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

FRUVED + LRC

EXPERIMENTAL

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

FRUVED + LF

EXPERIMENTAL

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

Interventions

FRUVEDomics BEHAVIORAL

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.

FRUVED; FRUVED + LF; FRUVED + LRC

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 28 years of age
• either showing evidence of metabolic syndrome or at risk for metabolic syndrome

You may not qualify if:

• no evidence of metabolic syndrome or of being at-risk for metabolic syndrome

Sponsors & Collaborators

• West Virginia University: lead
• University of Tennessee: collaborator
• University of New Hampshire: collaborator

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Related Links

• Olfert Research Lab

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Melissa D. Olfert, DrPH, RDN

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 interventions evaluated against the other and a control.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 14, 2017
• Study Start: January 15, 2015
• Primary Completion: December 15, 2016
• Study Completion: January 15, 2019
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share