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

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FRUVEDomics
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Healthy Diet, Fruits and Vegetables, Metabolome, Microbiome, Young Adults

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    FRUVED

    FRUVED + LRC

    FRUVED + LF

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in metabolic parameters at 8 weeks
    Metabolomic measures via blood sample

    Secondary Outcome Measures

    Change in microbiome parameters at 8 weeks
    Microbiome measures via stool sample
    Change in Weight and BMI at 8 weeks
    calculation with body weight and height
    Change in Blood pressure at 8 weeks
    Blood pressure, standard measurement equipment
    Change in Arterial stiffness at 8 weeks
    Measured via dopler

    Full Information

    First Posted
    April 5, 2017
    Last Updated
    October 2, 2018
    Sponsor
    West Virginia University
    Collaborators
    University of Tennessee, University of New Hampshire
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03115866
    Brief Title
    FRUVEDomics: Behavioral Intervention in Young Adults to Identify Metabolomics and Microbiome Risk
    Acronym
    FRUVEDomics
    Official Title
    FRUVEDomics Study: Use of a Behavioral Nutrition Intervention in Young Adults to Identify Modifiable Metabolomics and Microbiome Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2015 (Actual)
    Primary Completion Date
    December 15, 2016 (Actual)
    Study Completion Date
    January 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West Virginia University
    Collaborators
    University of Tennessee, University of New Hampshire

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Healthy Diet, Fruits and Vegetables, Metabolome, Microbiome, Young Adults

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    2 interventions evaluated against the other and a control.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FRUVED
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    FRUVED + LRC
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    FRUVED + LF
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    FRUVEDomics
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in metabolic parameters at 8 weeks
    Description
    Metabolomic measures via blood sample
    Time Frame
    Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
    Secondary Outcome Measure Information:
    Title
    Change in microbiome parameters at 8 weeks
    Description
    Microbiome measures via stool sample
    Time Frame
    Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
    Title
    Change in Weight and BMI at 8 weeks
    Description
    calculation with body weight and height
    Time Frame
    8 weeks
    Title
    Change in Blood pressure at 8 weeks
    Description
    Blood pressure, standard measurement equipment
    Time Frame
    8 weeks
    Title
    Change in Arterial stiffness at 8 weeks
    Description
    Measured via dopler
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    28 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melissa D. Olfert, DrPH, RDN
    Organizational Affiliation
    West Virginia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to share IPD at this time.
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    Links:
    URL
    http://melissa-olfert.davis.wvu.edu/research-projects/fruvedomics
    Description
    Olfert Research Lab

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

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