The Effect of Whole Grain on Gut Microbiome and Metabolic Health (3G)

University of Copenhagen

Status: Unknown

Conditions: Injury of Gastrointestinal Tract; Metabolic Disease

Treatments: Other: Whole grain; Other: Refined grain

Study type: Interventional

Funder types: Other

Identifiers

NCT01731366

M206

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups, including a placebo group

Refined grain

Placebo Comparator group

Description:

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)

Treatment:

Other: Refined grain

Whole grain

Active Comparator group

Description:

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)

Treatment:

Other: Whole grain