Clinical trial NCT03115866: FRUVEDomics: Behavioral Intervention in Young Adults to Identify Metabolomics and Microbiome Risk
Official title: FRUVEDomics Study: Use of a Behavioral Nutrition Intervention in Young Adults to Identify Modifiable Metabolomics and Microbiome Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Healthy Diet
Fruits and Vegetables
Metabolome
Microbiome
Young Adults
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: University of Tennessee
name: University of New Hampshire
First posted: 2017-04-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 interventions evaluated against the other and a control.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in metabolic parameters at 8 weeks
timeFrame: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
Secondary outcomes:
measure: Change in microbiome parameters at 8 weeks
timeFrame: Baseline (T0), Week 3 (T1), Week 5 (T2), and Post Week 8 (T3)
measure: Change in Weight and BMI at 8 weeks
timeFrame: 8 weeks
measure: Change in Blood pressure at 8 weeks
timeFrame: 8 weeks
measure: Change in Arterial stiffness at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: West Virginia University
name: Melissa D. Olfert, DrPH, RDN
role: PRINCIPAL_INVESTIGATOR
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