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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03115866
Acronym
FRUVEDomics
Enrollment
53
Registered
2017-04-14
Start date
2015-01-15
Completion date
2019-01-15
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

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

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.

Interventions

BEHAVIORALFRUVEDomics

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.

Sponsors

University of Tennessee
CollaboratorOTHER
University of New Hampshire
CollaboratorOTHER
West Virginia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

2 interventions evaluated against the other and a control.

Eligibility

Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in metabolic parameters at 8 weeksBaseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)Metabolomic measures via blood sample

Secondary

MeasureTime frameDescription
Change in microbiome parameters at 8 weeksBaseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)Microbiome measures via stool sample
Change in Weight and BMI at 8 weeks8 weekscalculation with body weight and height
Change in Blood pressure at 8 weeks8 weeksBlood pressure, standard measurement equipment
Change in Arterial stiffness at 8 weeks8 weeksMeasured via dopler

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026