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Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome X, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Dietary Flavonoids
Low Dietary Flavonoids
Sponsored by
Utah State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome X focused on measuring flavonoids, insulin resistance, plasma lipids, intestinal microbiome, intestinal inflammation, subclinical inflammation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI between 25 and 35 kg/m2

Exclusion Criteria:

  • Documented presence of atherosclerotic disease;
  • Diabetes mellitus
  • Uncontrolled hypertension
  • Renal, hepatic, endocrine, gastrointestinal or other systemic disease
  • For women, pregnancy, breast feeding or postpartum < 6 months
  • History of drug or alcohol abuse
  • History of depression or mental illness requiring hospitalization within the last 12 months
  • Use of antibiotics within the last 6 months
  • Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
  • Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
  • Lifestyle or schedule incompatible with the study protocol
  • Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol.

Sites / Locations

  • Utah State University, Center for Human Nutrition Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Flavonoids then High Flavonoids

High Flavonoids then Low Flavonoids

Arm Description

Participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks.

Participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks.

Outcomes

Primary Outcome Measures

Fecal calprotectin
Primary endpoint for intestinal inflammation
Serum C-reactive protein
One of two primary endpoints for systemic inflammation
Serum soluble tumor necrosis factor receptor-1
One of two primary endpoints for systemic inflammation
Serum insulin
Primary endpoint for insulin resistance

Secondary Outcome Measures

Fecal microbiome composition
Includes relative abundances of operational taxonomic units and assigned taxonomy as well as alpha and beta diversity measurements
Fecal short chain fatty acids
Measure of fecal microbiome metabolic capabilities and includes acetate, propionate, butyrate, valerate and caproate.
Fecal eosinophil protein X
Secondary endpoint for intestinal inflammation
Fecal myeloperoxidase
Secondary endpoint for intestinal inflammation
Intestinal permeability by four sugar differential absorption test
Secondary endpoint for intestinal inflammation
Serum endotoxin
Secondary endpoint for intestinal inflammation
Serum interleukin-6
Secondary endpoint for systemic inflammation
Serum soluble tumor necrosis factor receptor-2
Secondary endpoint for systemic inflammation
Serum fasting glucose
Secondary endpoint for insulin resistance
Calculated Homeostatic Model Assessment-Insulin Resistance
Secondary endpoint for insulin resistance
Serum C-peptide
Secondary endpoint for insulin resistance
Plasma lipids
Secondary endpoint for insulin resistance. Includes LDL-cholesterol, HDL-cholesterol and triglycerides
Blood pressure
Secondary endpoint for insulin resistance. Includes systolic and diastolic blood pressure

Full Information

First Posted
March 30, 2016
Last Updated
April 14, 2016
Sponsor
Utah State University
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1. Study Identification

Unique Protocol Identification Number
NCT02728570
Brief Title
Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
Official Title
Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Utah State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators have hypothesized that dietary flavonoids reduce insulin resistance and subclinical inflammation secondary to reductions in intestinal inflammation and permeability and that these events are mediated through alterations in gut microbiota composition. To test this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53% en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6 weeks each in a randomized cross-over design with endpoints determined in duplicate during the last week of each diet period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Inflammation
Keywords
flavonoids, insulin resistance, plasma lipids, intestinal microbiome, intestinal inflammation, subclinical inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Flavonoids then High Flavonoids
Arm Type
Experimental
Arm Description
Participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks.
Arm Title
High Flavonoids then Low Flavonoids
Arm Type
Experimental
Arm Description
Participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks.
Intervention Type
Other
Intervention Name(s)
High Dietary Flavonoids
Intervention Description
A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing high levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids.
Intervention Type
Other
Intervention Name(s)
Low Dietary Flavonoids
Intervention Description
A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing low levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids.
Primary Outcome Measure Information:
Title
Fecal calprotectin
Description
Primary endpoint for intestinal inflammation
Time Frame
6 weeks
Title
Serum C-reactive protein
Description
One of two primary endpoints for systemic inflammation
Time Frame
6 weeks
Title
Serum soluble tumor necrosis factor receptor-1
Description
One of two primary endpoints for systemic inflammation
Time Frame
6 weeks
Title
Serum insulin
Description
Primary endpoint for insulin resistance
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fecal microbiome composition
Description
Includes relative abundances of operational taxonomic units and assigned taxonomy as well as alpha and beta diversity measurements
Time Frame
6 weeks
Title
Fecal short chain fatty acids
Description
Measure of fecal microbiome metabolic capabilities and includes acetate, propionate, butyrate, valerate and caproate.
Time Frame
6 weeks
Title
Fecal eosinophil protein X
Description
Secondary endpoint for intestinal inflammation
Time Frame
6 weeks
Title
Fecal myeloperoxidase
Description
Secondary endpoint for intestinal inflammation
Time Frame
6 weeks
Title
Intestinal permeability by four sugar differential absorption test
Description
Secondary endpoint for intestinal inflammation
Time Frame
6 weeks
Title
Serum endotoxin
Description
Secondary endpoint for intestinal inflammation
Time Frame
6 weeks
Title
Serum interleukin-6
Description
Secondary endpoint for systemic inflammation
Time Frame
6 weeks
Title
Serum soluble tumor necrosis factor receptor-2
Description
Secondary endpoint for systemic inflammation
Time Frame
6 weeks
Title
Serum fasting glucose
Description
Secondary endpoint for insulin resistance
Time Frame
6 weeks
Title
Calculated Homeostatic Model Assessment-Insulin Resistance
Description
Secondary endpoint for insulin resistance
Time Frame
6 weeks
Title
Serum C-peptide
Description
Secondary endpoint for insulin resistance
Time Frame
6 weeks
Title
Plasma lipids
Description
Secondary endpoint for insulin resistance. Includes LDL-cholesterol, HDL-cholesterol and triglycerides
Time Frame
6 weeks
Title
Blood pressure
Description
Secondary endpoint for insulin resistance. Includes systolic and diastolic blood pressure
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Serum resistin
Description
Measure of adipocyte inflammation and systemic metabolism
Time Frame
6 weeks
Title
Serum visfatin
Description
Measure of adipocyte inflammation and systemic metabolism
Time Frame
6 weeks
Title
Serum adiponectin
Description
Measure of adipocyte inflammation and systemic metabolism
Time Frame
6 weeks
Title
Serum leptin
Description
Measure of adipocyte inflammation and systemic metabolism
Time Frame
6 weeks
Title
Body weight
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI between 25 and 35 kg/m2 Exclusion Criteria: Documented presence of atherosclerotic disease; Diabetes mellitus Uncontrolled hypertension Renal, hepatic, endocrine, gastrointestinal or other systemic disease For women, pregnancy, breast feeding or postpartum < 6 months History of drug or alcohol abuse History of depression or mental illness requiring hospitalization within the last 12 months Use of antibiotics within the last 6 months Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids Lifestyle or schedule incompatible with the study protocol Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lefevre, PhD
Organizational Affiliation
Utah State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Utah State University, Center for Human Nutrition Studies
City
Logan
State/Province
Utah
ZIP/Postal Code
84322-9815
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual data will be deposited into a public repository as the data are published.

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Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome

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