The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Obesity; Change of Transit or Circulation

Treatments: Dietary Supplement: Placebo; Dietary Supplement: soluble wheat bran fibre

Study type: Interventional

Funder types: Other

Identifiers

NCT02491125

NL52300.068.15

Details and patient eligibility

About

The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.

Full description

A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.

Enrollment: 48 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overweight to obese men and women (BMI ≥ 25 kg/m2 <35 kg/m2)
• Aged 20-50 years
• Caucasian
• Normal fasting glucose (<6.1 mmol/L.)
• Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
• Weight stable in last 3 months (±2 kg)
• A low defecation frequency, <4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
• A slow whole gut transit (>35h)

Exclusion criteria

• Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal

• Regular smokers

• People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)

• Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)

• Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years

• Following a hypocaloric diet

• Gluten intolerance

• Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study

• More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as

  1. Straining in >1/4 defecations;
  2. Lumpy or hard stools in >1/4 defecations;
  3. Sensation of incomplete evacuation in >1/4 defecations;
  4. Sensation of anorectal obstruction/blockade in >1/4 defecations
  5. Manual maneuvers to facilitate >1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
  6. <3 defecations/week

• Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses

• Not to be able to understand the study information

• Blood donation 2 months prior to the study and during the study

• Participation in other studies

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day)

Treatment:

Dietary Supplement: Placebo

soluble wheat bran fibre

Experimental group

Description:

12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day)

Treatment:

Dietary Supplement: soluble wheat bran fibre