NCT05417360Completed
Akkermansia and Weight Maintenance
Effect of Pasteurized Akkermansia Muciniphilia on Maintenance of Body Weight After a Low Calorie Diet
Source: ClinicalTrials.gov · Last updated 27 Nov 2023
Brief summary (registry, in English)
Obesity and related disorders such as type 2 diabetes are a worldwide diet-related problem. As such new treatment options are constantly being developed. Bacteria living in the gut seem to be a key player in the treatment of obesity and related metabolic diseases by influencing energy balance and the immune system. In terms of newly identified bacteria species, Akkermansia muciniphila (A. muciniphila) has been found to be related to obesity. Several animal studies have shown the beneficial impact of A. muciniphila on the treatment of body weight as well as insulin sensitivity. The growth requirements of live A. muciniphila as well as its oxygen sensitivity rendered this bacterium unsuitable for human investigations or putative therapeutic opportunities. Therefore, pasteurization, a mild heating method, and its impact on diet-induced metabolic disorders in mice were investigated. Unexpectedly, this method of inactivation did not negate the effect of A. muciniphila, but improved its beneficial metabolic effects. Pilot studies have provided further evidence that pasteurization of A. muciniphila is safe for human use and has the potential to beneficially affect the control of body weight and glucose metabolism. In this project, The investigators hypothesize that pasteurized A. muciniphila will be superior to placebo intervention in maintaining body weight after a phase of weight loss (low caloric diet) in adult participants with overweight or obesity.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 24 May 2022
- Start date
- 22 Jul 2022
- Primary completion date
- 20 Nov 2023
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Obesity
- NCT number
- NCT05417360
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 22 Jul 2022 to the primary completion date, 20 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery on the gastrointestinal tract (ex.Bariatric surgery)
- Alcohol (\>15 standard drinks per week) or drug abuse
- Use of prebiotics or probiotics 3 months prior to the start of the study;
- Concomitant participation in another study
Other illness
- Gastroenterological diseases
Lab values
- Type 2 diabetes mellitus (fasting plasma glucose ≥ 7.0 mmol/L)
- Use of any medication influencing glucose or fat metabolism (ex. lipid-lowering-drugs e.g. PPAR γ (peroxisome proliferator-activated receptors) or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide, and insulin), inflammation (e.g. anti-inflammatory or immunosuppressive drugs) and anti-oxidants);
Age
- Cardiovascular diseases, cancer, liver or kidney malfunction, a disease with a life expectancy of \< 5 years;
Other
- Excessive nicotine use is defined as \>20 cigarettes per day;
- Intensive exercise training, \> 3 hours a week;
- Regular use of laxatives
- Use of antibiotics in the last 3 months
- Vegan
- Lactose intolerance
- Pregnancy or lactation
Who the study is looking for
- BMI ≥ 28 kg/m2 \< 40 kg/m2
- Weight stable for at least 3 months (± 2 kg).
Age in the registry: 20 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Human Biology, Maastricht University Medical Centre Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.