Clinical trial NCT02728570: Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
Official title: Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Inflammation
Keywords: flavonoids
insulin resistance
plasma lipids
intestinal microbiome
intestinal inflammation
subclinical inflammation
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Fecal calprotectin
timeFrame: 6 weeks
measure: Serum C-reactive protein
timeFrame: 6 weeks
measure: Serum soluble tumor necrosis factor receptor-1
timeFrame: 6 weeks
measure: Serum insulin
timeFrame: 6 weeks
Secondary outcomes:
measure: Fecal microbiome composition
timeFrame: 6 weeks
measure: Fecal short chain fatty acids
timeFrame: 6 weeks
measure: Fecal eosinophil protein X
timeFrame: 6 weeks
measure: Fecal myeloperoxidase
timeFrame: 6 weeks
measure: Intestinal permeability by four sugar differential absorption test
timeFrame: 6 weeks
measure: Serum endotoxin
timeFrame: 6 weeks
measure: Serum interleukin-6
timeFrame: 6 weeks
measure: Serum soluble tumor necrosis factor receptor-2
timeFrame: 6 weeks
measure: Serum fasting glucose
timeFrame: 6 weeks
measure: Calculated Homeostatic Model Assessment-Insulin Resistance
timeFrame: 6 weeks
measure: Serum C-peptide
timeFrame: 6 weeks
measure: Plasma lipids
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
Other outcomes:
measure: Serum resistin
timeFrame: 6 weeks
measure: Serum visfatin
timeFrame: 6 weeks
measure: Serum adiponectin
timeFrame: 6 weeks
measure: Serum leptin
timeFrame: 6 weeks
measure: Body weight
timeFrame: 6 weeks
Locations:
city: Logan
country: United States
facility: Utah State University, Center for Human Nutrition Studies
state: Utah
Study officials:
affiliation: Utah State University
name: Michael Lefevre, PhD
role: PRINCIPAL_INVESTIGATOR
References: