Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02491125
Other study ID # NL52300.068.15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2