Change of Transit or Circulation, Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTsoluble wheat bran fibre
12 weeks daily intake of 15g of soluble wheat bran fibre
DIETARY_SUPPLEMENTPlacebo
12 weeks daily intake of 15g of maltodextrin
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole gut transit time [hours] | measured at baseline at week 1 and directly after the 12 week supplementation | Whole gut transit time as measured by radio-opaque marker method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oro-cecal transit time [min] | measured at baseline at week 1 and directly after the 12 week supplementation | Oro-cecal transit time measured by hydrogen breath test |
| Defecation frequency (bowel movement per day) | measured at baseline at week 1 and directly after the 12 week supplementation | Defecation frequency as measured via questionnaire |
| Energy expenditure | measured at baseline at week 1 and directly after the 12 week supplementation | Energy expenditure measured by indirect calorimetry |
| Substrate oxidation | measured at baseline at week 1 and directly after the 12 week supplementation | Fat and carbohydrate oxidation measured by indirect calorimetry |
| Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml) | measured at baseline at week 1 and directly after the 12 week supplementation | IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay |
| Gastric emptying [min] | measured at baseline at week 1 and directly after the 12 week supplementation | Gastric emptying measured by isotope breath test |
| Gut permeability | measured at baseline at week 1 and directly after the 12 week supplementation | Gut permeability as measured by multi sugar assay |
| Microbiota composition | measured at baseline at week 1 and directly after the 12 week supplementation | Microbiota composition as measured by illumina sequencing in feces |
| Fecal Short chain fatty acid concentrations | measured at baseline at week 1 and directly after the 12 week supplementation | Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection |
| Plasma short chain fatty acid concentrations | measured at baseline at week 1 and directly after the 12 week supplementation | Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry |
| Adipose tissue gene expression | measured at baseline at week 1 and directly after the 12 week supplementation | Adipose tissue gene expression measured by quantitative real time polymerase chain reaction |
Outcome results
None listed