The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects

Catholic University (KU) of Leuven

Status and phase: Completed; Phase 2; Phase 1

Conditions: Obese; Healthy

Treatments: Dietary Supplement: Wheat bran; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02796989

s58346

Details and patient eligibility

About

During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged between 18 and 65 years old
• BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
• Regular diet
• Not dieting

Exclusion criteria

• Use of antibiotics in the month preceding the study
• Diabetes Type 1 or 2
• Abdominal surgery (except from appendectomy)
• Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
• Use of pre- or probiotic supplements in the month preceding the study
• Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease...
• Pregnancy or lactation
• Blood donation in the last 3 months
• Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
• Participation in clinical studies involving radiation exposure in the past year

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 4 patient groups, including a placebo group

Healthy - Wheat Bran

Active Comparator group

Description:

Wheat bran 20 g each day

Treatment:

Dietary Supplement: Wheat bran

Healthy - Placebo

Placebo Comparator group

Description:

Placebo 20 g each day

Treatment:

Dietary Supplement: Placebo

Obese - Wheat bran

Active Comparator group

Description:

Wheat bran 20 g each day

Treatment:

Dietary Supplement: Wheat bran

Obese - Placebo

Placebo Comparator group

Description:

Placebo 20 g each day

Treatment:

Dietary Supplement: Placebo