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Completed

NCT Number: NCT02728570

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

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utah State University, Center for Human Nutrition Studies

Logan, Utah, 84322-9815, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Fecal calprotectin

    Time frame: 6 weeks

    Primary endpoint for intestinal inflammation

  2. Serum C-reactive protein

    Time frame: 6 weeks

    One of two primary endpoints for systemic inflammation

  3. Serum soluble tumor necrosis factor receptor-1

    Time frame: 6 weeks

    One of two primary endpoints for systemic inflammation

  4. Serum insulin

    Time frame: 6 weeks

    Primary endpoint for insulin resistance

Secondary outcomes

  1. Fecal microbiome composition

    Time frame: 6 weeks

    Includes relative abundances of operational taxonomic units and assigned taxonomy as well as alpha and beta diversity measurements

  2. Fecal short chain fatty acids

    Time frame: 6 weeks

    Measure of fecal microbiome metabolic capabilities and includes acetate, propionate, butyrate, valerate and caproate.

  3. Fecal eosinophil protein X

    Time frame: 6 weeks

    Secondary endpoint for intestinal inflammation

  4. Fecal myeloperoxidase

    Time frame: 6 weeks

    Secondary endpoint for intestinal inflammation

  5. Intestinal permeability by four sugar differential absorption test

    Time frame: 6 weeks

    Secondary endpoint for intestinal inflammation

  6. Serum endotoxin

    Time frame: 6 weeks

    Secondary endpoint for intestinal inflammation

  7. Serum interleukin-6

    Time frame: 6 weeks

    Secondary endpoint for systemic inflammation

  8. Serum soluble tumor necrosis factor receptor-2

    Time frame: 6 weeks

    Secondary endpoint for systemic inflammation

  9. Serum fasting glucose

    Time frame: 6 weeks

    Secondary endpoint for insulin resistance

  10. Calculated Homeostatic Model Assessment-Insulin Resistance

    Time frame: 6 weeks

    Secondary endpoint for insulin resistance

  11. Serum C-peptide

    Time frame: 6 weeks

    Secondary endpoint for insulin resistance

  12. Plasma lipids

    Time frame: 6 weeks

    Secondary endpoint for insulin resistance. Includes LDL-cholesterol, HDL-cholesterol and triglycerides

  13. Blood pressure

    Time frame: 6 weeks

    Secondary endpoint for insulin resistance. Includes systolic and diastolic blood pressure

Other outcomes

  1. Serum resistin

    Time frame: 6 weeks

    Measure of adipocyte inflammation and systemic metabolism

  2. Serum visfatin

    Time frame: 6 weeks

    Measure of adipocyte inflammation and systemic metabolism

  3. Serum adiponectin

    Time frame: 6 weeks

    Measure of adipocyte inflammation and systemic metabolism

  4. Serum leptin

    Time frame: 6 weeks

    Measure of adipocyte inflammation and systemic metabolism

  5. Body weight

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Utah State University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 5, 2016
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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