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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728570
• Other study ID #: USU #5483
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: April 14, 2016
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Utah State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome X
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Utah State University, Center for Human Nutrition Studies	Logan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Utah State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum resistin	Measure of adipocyte inflammation and systemic metabolism	6 weeks	No
Other	Serum visfatin	Measure of adipocyte inflammation and systemic metabolism	6 weeks	No
Other	Serum adiponectin	Measure of adipocyte inflammation and systemic metabolism	6 weeks	No
Other	Serum leptin	Measure of adipocyte inflammation and systemic metabolism	6 weeks	No
Other	Body weight		6 weeks	No
Primary	Fecal calprotectin	Primary endpoint for intestinal inflammation	6 weeks	No
Primary	Serum C-reactive protein	One of two primary endpoints for systemic inflammation	6 weeks	No
Primary	Serum soluble tumor necrosis factor receptor-1	One of two primary endpoints for systemic inflammation	6 weeks	No
Primary	Serum insulin	Primary endpoint for insulin resistance	6 weeks	No
Secondary	Fecal microbiome composition	Includes relative abundances of operational taxonomic units and assigned taxonomy as well as alpha and beta diversity measurements	6 weeks	No
Secondary	Fecal short chain fatty acids	Measure of fecal microbiome metabolic capabilities and includes acetate, propionate, butyrate, valerate and caproate.	6 weeks	No
Secondary	Fecal eosinophil protein X	Secondary endpoint for intestinal inflammation	6 weeks	No
Secondary	Fecal myeloperoxidase	Secondary endpoint for intestinal inflammation	6 weeks	No
Secondary	Intestinal permeability by four sugar differential absorption test	Secondary endpoint for intestinal inflammation	6 weeks	No
Secondary	Serum endotoxin	Secondary endpoint for intestinal inflammation	6 weeks	No
Secondary	Serum interleukin-6	Secondary endpoint for systemic inflammation	6 weeks	No
Secondary	Serum soluble tumor necrosis factor receptor-2	Secondary endpoint for systemic inflammation	6 weeks	No
Secondary	Serum fasting glucose	Secondary endpoint for insulin resistance	6 weeks	No
Secondary	Calculated Homeostatic Model Assessment-Insulin Resistance	Secondary endpoint for insulin resistance	6 weeks	No
Secondary	Serum C-peptide	Secondary endpoint for insulin resistance	6 weeks	No
Secondary	Plasma lipids	Secondary endpoint for insulin resistance. Includes LDL-cholesterol, HDL-cholesterol and triglycerides	6 weeks	No
Secondary	Blood pressure	Secondary endpoint for insulin resistance. Includes systolic and diastolic blood pressure	6 weeks	No