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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by University of Memphis.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02512107
First Posted: July 30, 2015
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Memphis
  Purpose

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.


Condition Intervention
Inflammation Dietary Supplement: Juice Plus+ Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Juice Plus+ on the Microbiome, Intestinal Permeability and Inflammatory Status of Psychologically Stressed Individuals With High Body Mass Indices

Further study details as provided by University of Memphis:

Primary Outcome Measures:
  • Changes in intestinal microbiome composition induced by a fruit and vegetable supplement using 16S rRNA sequencing analysis [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Changes in intestinal permeability by biochemical analysis [ Time Frame: 1 year ]
  • Changes in systemic inflammatory molecules by cytokine analysis [ Time Frame: 1 year ]

Estimated Enrollment: 80
Study Start Date: January 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Juice Plus+
Subject will be taking supplement.
Dietary Supplement: Juice Plus+
Dried fruit and vegetable juice capsule.
Placebo Comparator: Placebo
Subjects will be taking the placebo.
Other: Placebo
Placebo capsule

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking,including smokeless tobacco
  • Chronic/excessive alcohol use
  • Pregnant or lactating
  • Recent surgery or illness
  • Diabetes
  • Heart disease
  • Use of antibiotics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512107


Contacts
Contact: Marie van der Merwe, PhD 901 678 4576 mvndrmrw@memphis.edu

Locations
United States, Tennessee
The University of Memphis Recruiting
Memphis, Tennessee, United States, 38152
Contact: Marie van der Merwe, PhD    901-678-3476    mvndrmrw@memphis.edu   
Sponsors and Collaborators
University of Memphis
Investigators
Principal Investigator: Marie van der Merwe, PhD University of Memphis
  More Information

Responsible Party: University of Memphis
ClinicalTrials.gov Identifier: NCT02512107     History of Changes
Other Study ID Numbers: 560061
First Submitted: July 1, 2015
First Posted: July 30, 2015
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Inflammation
Pathologic Processes