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

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ClinicalTrials.gov Identifier: NCT02728570
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Utah State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Inflammation Other: High Dietary Flavonoids Other: Low Dietary Flavonoids Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
Study Start Date : November 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Flavonoids then High Flavonoids
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
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.

Other: Low Dietary Flavonoids
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.
Experimental: High Flavonoids then Low Flavonoids
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
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.

Other: Low Dietary Flavonoids
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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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): NCT02728570


Locations
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United States, Utah
Utah State University, Center for Human Nutrition Studies
Logan, Utah, United States, 84322-9815
Sponsors and Collaborators
Utah State University
Investigators
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Principal Investigator: Michael Lefevre, PhD Utah State University
More Information
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Responsible Party: Utah State University
ClinicalTrials.gov Identifier: NCT02728570    
Other Study ID Numbers: USU #5483
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual data will be deposited into a public repository as the data are published.
Keywords provided by Utah State University:
flavonoids
insulin resistance
plasma lipids
 intestinal microbiome
intestinal inflammation
subclinical inflammation
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Inflammation
Disease
Pathologic Processes
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases