NCT02491125

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 8, 2019

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

March 23, 2015

Last Update Submit

July 4, 2019

Conditions

Change of Transit or CirculationObesity

Outcome Measures

Primary Outcomes (1)

  • Whole gut transit time [hours]

    Whole gut transit time as measured by radio-opaque marker method

    measured at baseline at week 1 and directly after the 12 week supplementation

Secondary Outcomes (11)

  • Gastric emptying [min]

    measured at baseline at week 1 and directly after the 12 week supplementation

  • Oro-cecal transit time [min]

    measured at baseline at week 1 and directly after the 12 week supplementation

  • Defecation frequency (bowel movement per day)

    measured at baseline at week 1 and directly after the 12 week supplementation

  • Energy expenditure

    measured at baseline at week 1 and directly after the 12 week supplementation

  • Substrate oxidation

    measured at baseline at week 1 and directly after the 12 week supplementation

  • +6 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

soluble wheat bran fibre

EXPERIMENTAL

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

Dietary Supplement: soluble wheat bran fibre

Interventions

soluble wheat bran fibreDIETARY_SUPPLEMENT

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

soluble wheat bran fibre
PlaceboDIETARY_SUPPLEMENT

12 weeks daily intake of 15g of maltodextrin

Also known as: Maltodextrin
Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31983281DERIVED

MeSH Terms

Conditions

Obesity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

July 7, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 8, 2019

Record last verified: 2018-10