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Prebiotic fibre study

Effect of prebiotic fibres on Intestinal Health and Functioning

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23115
Enrollment
50
Registered
2015-03-16
Start date
2015-05-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Gastrointestinal Health, Metabolic Health

Interventions

1. Wheat-derived, Arabinoxylan-oligosaccharides (AXOS) 15g/day ingested with the meals (5 g in beverage, to be consumed three times a day) 2. Placebo: maltodextrin 15g/day ingested with the meals (

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Overweight to obese men and women (BMI &#8805; 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, <3 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires). - A low whole gut transit

Exclusion criteria

Exclusion criteria: 4.3 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 (&#8805;3 per week &#8805; 1 hour training) - Diabetes Mellitus (defined as FPG &#8805; 7.0 mmol/l and or 2h PG &#8805; 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

Design outcomes

Primary

MeasureTime frame
Whole gut transit time

Secondary

MeasureTime frame
Markers of gastrointestinal health

Contacts

Public ContactMuller
m.muller@maastrichtuniversity.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)