The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism

Obesity Clinical Trial

Official title:

Effect of Prebiotic Fibre on Intestinal Health and Functioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491125
• Other study ID #: NL52300.068.15
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Change of Transit or Circulation
• Obesity

Intervention

Dietary Supplement:
• soluble wheat bran fibre
12 weeks daily intake of 15g of soluble wheat bran fibre
• Placebo
12 weeks daily intake of 15g of maltodextrin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gastric emptying [min]	Gastric emptying measured by isotope breath test	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Oro-cecal transit time [min]	Oro-cecal transit time measured by hydrogen breath test	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Defecation frequency (bowel movement per day)	Defecation frequency as measured via questionnaire	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Energy expenditure	Energy expenditure measured by indirect calorimetry	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Substrate oxidation	Fat and carbohydrate oxidation measured by indirect calorimetry	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)	IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Adipose tissue gene expression	Adipose tissue gene expression measured by quantitative real time polymerase chain reaction	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Gut permeability	Gut permeability as measured by multi sugar assay	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Microbiota composition	Microbiota composition as measured by illumina sequencing in feces	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Fecal Short chain fatty acid concentrations	Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection	measured at baseline at week 1 and directly after the 12 week supplementation
Secondary	Plasma short chain fatty acid concentrations	Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry	measured at baseline at week 1 and directly after the 12 week supplementation