obesity overweight
Conditions
Interventions
Sponsors
Danisco Sweeteners Oy
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Female * Age: 25-50y; In case of sufficient eligible subjects, the age distribution of the two groups will be aligned, and the age range will be reduced to max. 10 y between highest and lowest age. * Lean: BMI 19-23 kg/m2, waist circumference 88 cm, and fasting glucose >
Exclusion criteria
Exclusion criteria: * Participation in any clinical trial with oral, intravenous or inhalatory administration of any substances during 90 days before study start * History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject*s ability to participate in the study: o type 1 or type 2 diabetes o gastrointestinal disease o bariatric surgery o cardiovascular disease, liver or renal failure or disease of kidney or thyroid gland, cancer o infectious disease, history of chronic active inflammatory disorders, food allergy * Use of antibiotics during the one (1) year prior to study start: if this criterion restricts inclusion too much, we will lower this timeframe to six (6) months. * Constipation/infrequent bowel movement (defecation 15 units/week and >3/day, and/or not willing to stop during the study * Drug abuse, and not willing/able to stop this during the study * Heavy exercise or sports training > 10 hours/week * Smoking * Active or recent participation in a weight loss program including weight change (increase or loss) of >3 kg during the last three (3) months * Reported unexplained weight loss or weight gain of > 5 kg in the year prior to pre-study screening * Reported slimming or medically prescribed diet * Reported special diets such as vegetarian, vegan, macrobiotic, low carbohydrate, dairy-free, or diets with intention to use certain limited food groups only (e.g. paleo diet, egg-grape diet) * Pregnant or planning to become pregnant during the study, breastfeeding (subjects will be asked to perform a urine pregnancy test on the study day, before swallowing the caspule) * Postmenopausal women on unstable hormone replacement therapy (periodical hormone treatment such as contraceptives is no exclusion criterion) * Not willing to accept information-transfer concerning participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in microbiota composition in the upper GI tract between lean and obese subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total bacterial count measured by qPCR in SI samples of lean versus obese subjects; biomarkers measured in blood (fasting) at baseline and on the sampling day: glucose, insulin, cholesterol, IL-1, IL-6, TNF-a, in relation to microbiota composition. | — |
Countries
The Netherlands
Outcome results
None listed