In this project we intends to study the efficacy of pasteurized A. muciniphila for protection against weight regain in individuals with overweight/obesity, and aims to address the following key objectives: 1. To investigate the effects of…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Health condition
obesity
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
changes in body weight
Secondary outcome
Changes in body composition, glucose metabolism, insulin sensitivity and
metabolic health by evaluation the following parameters:
- BMI, waist and hip corcumference and body composition (DEXA scan)
- cirulating metabolites, hormones and inflammatory markers
- adipose tissue gene/protein expression
- faecal and circulating SCFA
- faecal microbiota composition
Background summary
The causal beneficial impact of A. muciniphila on obesity has been
demonstrated by a variety of studies in animal models. In the meantime,
small-scale human studies provide evidence that pasteurization of A.
muciniphila is safe for human use and has great potential to beneficially
affect control of body weight and glucose homeostasis in humans.
Therefore, in this project we hypothesize that pasteurized Akkermansia
muciniphila will be superior to placebo intervention in maintaining body weight
after a low caloric diet in participants with overweight or obesity after a
phase of weight loss.
Study objective
In this project we intends to study the efficacy of pasteurized A. muciniphila
for protection against weight regain in individuals with overweight/obesity,
and aims to address the following key objectives:
1. To investigate the effects of pasteurized Akkermansia muciniphila on the
maintenance of body weight after a phase of weight loss.
2. To investigate the effects of pasteurized Akkermansia muciniphila on body
composition and body fat distribution, glucose homeostasis and insulin
sensitivity and metabolic health.
3. To investigate the effects of pasteurized Akkermansia muciniphila on the
faecal bacterial composition and functionality, systemic inflammation, gut
barrier function and identify relevant biomarkers
Study design
Double blind, controlled, randomized, parallel design.
Intervention
The participants will first undergo a low caloric diet (LCD, ~900kcal) for 8
weeks. Participants that loss at least 8% of weight will be randomized (with
stratification for age and sex) in a weight maintenance period in which they
either receive pasteurized Akkermansia muciniphila or placebo for 6 months.
Study burden and risks
Burdens that volunteers can experience, such as the time spent with the study.
Also the intake of the products during the LCD and weight maintenance period
can be seen as a burden for the participants.
During the LCD, the participants might experience headaches, dizziness,
tiredness and nausea might occur due to the reduced energy and particularly
carbohydrate intake (particularly in the first few days) during the weight loss
period.
Venepunctures can occasionally cause a local hematoma or bruise to occur. Some
participants report pain during venepuncture.
During CID 1, 2 and 3 adipose tissue biopsies will be taken. The adipose tissue
biopsy might cause local hematoma as well. To minimize the risk for a hematoma,
the biopsy place will be compressed for approximately 5 minutes after biopsy.
The place of incision will potentially leave a small scar (* 3 mm ). To promote
good wound healing, the incision will be sealed with sterile steristrips and a
waterproof band-aid.
Universiteitssingel 50
Maastricht 5229ER
NL
Universiteitssingel 50
Maastricht 5229ER
NL
Listed location countries
Age
Inclusion criteria
Overweight/obese (BMI >= 28 kg/m2 < 40 kg/m2) men and women
Exclusion criteria
- diabetes mellitus
- gastroenterological diseases or major abdominal surgery (allowed i.e.:
appendectomy, cholecystectomy)
- lactose intolerance and other digestive disorders
- cardiovascular disease, cancer, liver or kidney malfunction (determined based
on ALAT and creatinine levels,
respectively)
- disease with a life expectancy shorter than 5 years
- abuse of products (alcohol consumption > 15 units/week, or any drugs)
- excessive nicotine use defined as >20 cigarettes per day
- plans to lose weight or follow a hypocaloric diet
- regular supplement of pre- or probiotic products
- intensive exercise more than three hours a week
- Use of any medication that influences glucose or fat metabolism, like
lipidlowering-drugs (e.g. PPAR γ or PPARα (fibrates) agonists),
glucose-lowering agents (including allsulfonylureas, biguanides, α-glucosidase
inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin),
inflammation (e.g. anti-inflammatory or immunosuppressive drugs) and
anti-oxidants;
- use of laxation products in the last three months or during the study period-
Suikerziekte heeft;
- Pregnancy and lactation
-vegan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80563.068.22 |