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

Metabolic Syndrome Clinical Trial

— FRUVEDomics  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03115866
• Other study ID #: 1409433435
• Secondary ID: 2014-67001-21851
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2015
• Est. completion date: January 15, 2019

Study information

• Verified date: October 2018
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: January 15, 2019
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
West Virginia University	University of New Hampshire, University of Tennessee

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Change in Weight and BMI at 8 weeks	calculation with body weight and height	8 weeks
Secondary	Change in Blood pressure at 8 weeks	Blood pressure, standard measurement equipment	8 weeks
Secondary	Change in Arterial stiffness at 8 weeks	Measured via dopler	8 weeks

External Links

•   Olfert Research Lab