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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

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Fecal calprotectin [ Time Frame: 6 weeks ]
    Primary endpoint for intestinal inflammation
  • Serum C-reactive protein [ Time Frame: 6 weeks ]
    One of two primary endpoints for systemic inflammation
  • Serum soluble tumor necrosis factor receptor-1 [ Time Frame: 6 weeks ]
    One of two primary endpoints for systemic inflammation
  • Serum insulin [ Time Frame: 6 weeks ]
    Primary endpoint for insulin resistance
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • 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
  • Fecal short chain fatty acids [ Time Frame: 6 weeks ]
    Measure of fecal microbiome metabolic capabilities and includes acetate, propionate, butyrate, valerate and caproate.
  • Fecal eosinophil protein X [ Time Frame: 6 weeks ]
    Secondary endpoint for intestinal inflammation
  • Fecal myeloperoxidase [ Time Frame: 6 weeks ]
    Secondary endpoint for intestinal inflammation
  • Intestinal permeability by four sugar differential absorption test [ Time Frame: 6 weeks ]
    Secondary endpoint for intestinal inflammation
  • Serum endotoxin [ Time Frame: 6 weeks ]
    Secondary endpoint for intestinal inflammation
  • Serum interleukin-6 [ Time Frame: 6 weeks ]
    Secondary endpoint for systemic inflammation
  • Serum soluble tumor necrosis factor receptor-2 [ Time Frame: 6 weeks ]
    Secondary endpoint for systemic inflammation
  • Serum fasting glucose [ Time Frame: 6 weeks ]
    Secondary endpoint for insulin resistance
  • Calculated Homeostatic Model Assessment-Insulin Resistance [ Time Frame: 6 weeks ]
    Secondary endpoint for insulin resistance
  • Serum C-peptide [ Time Frame: 6 weeks ]
    Secondary endpoint for insulin resistance
  • Plasma lipids [ Time Frame: 6 weeks ]
    Secondary endpoint for insulin resistance. Includes LDL-cholesterol, HDL-cholesterol and triglycerides
  • Blood pressure [ Time Frame: 6 weeks ]
    Secondary endpoint for insulin resistance. Includes systolic and diastolic blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2016)
  • Serum resistin [ Time Frame: 6 weeks ]
    Measure of adipocyte inflammation and systemic metabolism
  • Serum visfatin [ Time Frame: 6 weeks ]
    Measure of adipocyte inflammation and systemic metabolism
  • Serum adiponectin [ Time Frame: 6 weeks ]
    Measure of adipocyte inflammation and systemic metabolism
  • Serum leptin [ Time Frame: 6 weeks ]
    Measure of adipocyte inflammation and systemic metabolism
  • Body weight [ Time Frame: 6 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
Official Title  ICMJE Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Metabolic Syndrome X
  • Inflammation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: High Dietary Flavonoids
    • Other: Low Dietary Flavonoids
  • 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.
    Interventions:
    • Other: High Dietary Flavonoids
    • Other: Low Dietary Flavonoids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2016)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728570
Other Study ID Numbers  ICMJE USU #5483
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual data will be deposited into a public repository as the data are published.
Responsible Party Utah State University
Study Sponsor  ICMJE Utah State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Lefevre, PhD Utah State University
PRS Account Utah State University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP