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Effect of pasteurized Akkermansia muciniphila on maintenance of body weight after a low caloric diet

Effect of pasteurized Akkermansia muciniphila on maintenance of body weight after a low caloric diet - Akkermansia and weight maintenance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51753
Enrollment
108
Registered
2022-05-30
Start date
2022-08-25
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity insulin resistance overweight

Interventions

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

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Overweight/obese (BMI >= 28 kg/m2

Exclusion criteria

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 PPARa (fibrates) agonists), glucose-lowering agents (including allsulfonylureas, biguanides, a-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 outcomes

Primary

MeasureTime frame
changes in body weight

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)