The Effect of Whole Grain on Gut Microbiome and Metabolic Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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Objective: To identify how specific changes of the whole grain content in the diet affect the host-gut microbiome interactions with implications for metabolic health .

Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included.

Intervention: low vs. high whole grain intake.

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Detailed Description

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The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a diet rich in whole grain in the active treatment period and a refined grain diet during the control period.

Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, appetite hormones, transit time, and GM composition. Furthermore, selected control measures are included; 4-day food records and a study intervention diary.

Conditions

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Metabolic Disease Injury of Gastrointestinal Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Refined grain

Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)

Group Type PLACEBO_COMPARATOR

Refined grain

Intervention Type OTHER

Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)

Whole grain

Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)

Group Type ACTIVE_COMPARATOR

Whole grain

Intervention Type OTHER

Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)

Interventions

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Whole grain

Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)

Intervention Type OTHER

Refined grain

Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI): 25 - 35 kg/m2
* No medical prescribed diet
* Weight stable
* No blood donation during the study
* Intense sporting activities less than 10h/ week
* Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male)
* Signed written consent

Exclusion Criteria

* Pharmacological treatment; hypertension, diabetes and blood lipid regulation
* Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
* Participation in another biomedical trial 1 month prior to study start
* Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
* Reported chronic gastrointestinal disorders
* Antibiotic treatment for 3 month prior to study start
* Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start
* Blood hemoglobin \< 7.0 mmol/l
* Blood donation within 1 month prior to study start

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes