Impact of JuicePlus+ on the Health Status of an Overweight Stressed Population

NCT02512107 | Completed

• 1 other identifier: 560061
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a dried fruit and vegetable supplement (Juice Plus+) can alter the gut microbiome and improve gut permeability and inflammatory levels in an obese, stressed population. The microbiome and its component genes are long known as critical determinants of the nutritional value of the food we eat. Recently, it has become clear that the composition of this microbiome and its metabolites influences the host immune system, thereby altering host physiology. Both obesity and chronic stress have been shown to have an altered gut microbiome; both these conditions also lead to increased systemic inflammatory molecules that can lead to an increased risk for type 2 diabetes and other diseases caused by chronic inflammation. Juice Plus+ consumed by an overweight population combined with an eight week exercise regime showed decreased markers of protein/lipid oxidation (ox-LDL), total lipid oxidation (TOS) and lowered systemic concentrations of the inflammatory cytokine, TNF-α. As systemic cytokines are altered by the composition of the gut microbiome, this study proposes to determine if this decrease in inflammation by Juice Plus+ is due to a change in the species composition and metabolism of the microbiome. This question is particularly relevant for populations with high inflammatory loads resulting from excess weight in addition to increased psychological stress. The investigators propose to determine 1) how Juice Plus+ consumption alters the microbiome species composition and metabolism, 2) if there is an alteration in intestinal permeability with the consumption of Juice Plus+ and 3) do these alterations coincide with lower systemic markers of inflammation and oxidative stress among individuals who are psychologically stressed and overweight. The investigators will use a randomized, placebo-controlled design with a cohort of overweight, female, critical care health care professionals. Subjects will receive the supplements or placebo for sixteen weeks. At the end of 16 weeks, the cohort receiving the supplement will be randomized to also receive a meal replacement component or follow their normal diet for an additional 4 weeks. Stool and a fasting blood sample will be collected at the beginning of the study (baseline) and 8, 16 and 20 weeks later. At each time point, subjects will also consume a cocktail of glucose, mannitol and lactulose and a second blood draw performed to look at absorption of these molecules.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Changes in intestinal microbiome composition induced by a fruit and vegetable supplement using 16S rRNA sequencing analysis

  1 year

Secondary Outcomes (2)

• Changes in intestinal permeability by biochemical analysis

  1 year

• Changes in systemic inflammatory molecules by cytokine analysis

  1 year

Study Arms (2)

Juice Plus+

ACTIVE COMPARATOR

Subject will be taking supplement.

Dietary Supplement: Juice Plus+

Placebo

PLACEBO COMPARATOR

Subjects will be taking the placebo.

Other: Placebo

Interventions

Juice Plus+ DIETARY_SUPPLEMENT

Dried fruit and vegetable juice capsule.

Juice Plus+

Placebo OTHER

Placebo capsule

Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Critical care health care professional
• Premenopausal
• Overweight or obese (BMI: 25-40 kg/m2)
• Between the ages of 25-50

You may not qualify if:

• Smoking,including smokeless tobacco
• Chronic/excessive alcohol use
• Pregnant or lactating
• Recent surgery or illness
• Diabetes
• Heart disease
• Use of antibiotics

Sponsors & Collaborators

• University of Memphis: lead

Study Sites (1)

The University of Memphis

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie van der Merwe, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 30, 2015
• Study Start: January 1, 2015
• Primary Completion: April 27, 2019
• Study Completion: April 27, 2019
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)