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

NCT02728570 | Completed

• 1 other identifier: USU #5483
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome X; Inflammation

Keywords

flavonoids; insulin resistance; plasma lipids; intestinal microbiome; intestinal inflammation; subclinical inflammation

Outcome Measures

Primary Outcomes (4)

• Fecal calprotectin

  Primary endpoint for intestinal inflammation

  6 weeks

• Serum C-reactive protein

  One of two primary endpoints for systemic inflammation

  6 weeks

• Serum soluble tumor necrosis factor receptor-1

  One of two primary endpoints for systemic inflammation

  6 weeks

• Serum insulin

  Primary endpoint for insulin resistance

  6 weeks

Secondary Outcomes (13)

• Fecal microbiome composition

  6 weeks

• Fecal short chain fatty acids

  6 weeks

• Fecal eosinophil protein X

  6 weeks

• Fecal myeloperoxidase

  6 weeks

• Intestinal permeability by four sugar differential absorption test

  6 weeks

Other Outcomes (5)

• Serum resistin

  6 weeks

• Serum visfatin

  6 weeks

• Serum adiponectin

  6 weeks

Study Arms (2)

Low Flavonoids then High Flavonoids

EXPERIMENTAL

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.

Other: High Dietary Flavonoids; Other: Low Dietary Flavonoids

High Flavonoids then Low Flavonoids

EXPERIMENTAL

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.

Other: High Dietary Flavonoids; Other: Low Dietary Flavonoids

Interventions

High Dietary Flavonoids OTHER

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.

High Flavonoids then Low Flavonoids; Low Flavonoids then High Flavonoids

Low Dietary Flavonoids OTHER

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.

High Flavonoids then Low Flavonoids; Low Flavonoids then High Flavonoids

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 25 and 35 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Utah State University: lead

Study Sites (1)

Utah State University, Center for Human Nutrition Studies

Logan, Utah, 84322-9815, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Lefevre, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 5, 2016
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)