The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

NCT ID: NCT02491125

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-31

Brief Summary

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

Detailed 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.

Conditions

Change of Transit or Circulation; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

12 weeks daily intake of 15g of maltodextrin

soluble wheat bran fibre

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

Group Type: EXPERIMENTAL

soluble wheat bran fibre

Intervention Type: DIETARY_SUPPLEMENT

12 weeks daily intake of 15g of soluble wheat bran fibre

Interventions

soluble wheat bran fibre

12 weeks daily intake of 15g of soluble wheat bran fibre

Intervention Type: DIETARY_SUPPLEMENT

Placebo

12 weeks daily intake of 15g of maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Maltodextrin

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Muller M, Hermes GDA, Emanuel E C, Holst JJ, Zoetendal EG, Smidt H, Troost F, Schaap FG, Damink SO, Jocken JWE, Lenaerts K, Masclee AAM, Blaak EE. Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. Gut Microbes. 2020 Nov 9;12(1):1704141. doi: 10.1080/19490976.2019.1704141. Epub 2020 Jan 25.

Reference Type: DERIVED

PMID: 31983281 (View on PubMed)

Other Identifiers

NL52300.068.15

Identifier Type: -

Identifier Source: org_study_id