Akkermansia and Weight Maintenance

NCT05417360 | Completed DMC

• 1 other identifier: NL80563.068.22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Microtia; Metabolic Syndrome; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Body weight

  Changes in body weight following the initial weight loss period will be monitored over the weight maintenance period.

  6 months

Secondary Outcomes (20)

• Body composition

  8 months

• Body fat distribution

  8 months

• Glucose metabolism

  8 months

• Insulin sensitivity

  8 months

• Lipid profile

  8 months

Other Outcomes (2)

• Physical activity

  8 months

• Diet

  8 months

Study Arms (2)

Akkermansia muciniphila (A. muciniphila)

EXPERIMENTAL

After an 8-week low caloric diet (LCD, \~800kcal), participants who have successfully lost 8% of their body weight who are randomized to the intervention group, will receive pasteurized A. muciniphila.

Dietary Supplement: Akkermansia muciniphila

Placebo

PLACEBO COMPARATOR

After an 8-week low caloric diet (LCD, \~800kcal), participants who have successfully lost 8% of their body weight who are randomized to the control group, will receive a placebo.

Dietary Supplement: Placebo

Interventions

Akkermansia muciniphila DIETARY_SUPPLEMENT

During the weight management period (weeks 8 to 32), the pasteurized A. muciniphila product will be orally consumed in water at least 15 min before breakfast for a period of 6 months (24 weeks) capsules. It appears as a white homogenous powder. .

Akkermansia muciniphila (A. muciniphila)

Placebo DIETARY_SUPPLEMENT

During the weight management period (weeks 8 to 32), the placebo product will be orally consumed in water at least 15 min before breakfast for a period of 6 months (24 weeks). It appears as a white homogenous powder.

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 28 kg/m2 \< 40 kg/m2
• Weight stable for at least 3 months (± 2 kg).

You may not qualify if:

• Type 2 diabetes mellitus (fasting plasma glucose ≥ 7.0 mmol/L)
• Gastroenterological diseases
• Surgery on the gastrointestinal tract (ex.Bariatric surgery)
• Cardiovascular diseases, cancer, liver or kidney malfunction, a disease with a life expectancy of \< 5 years;
• Alcohol (\>15 standard drinks per week) or drug abuse
• Excessive nicotine use is defined as \>20 cigarettes per day;
• Use of prebiotics or probiotics 3 months prior to the start of the study;
• Intensive exercise training, \> 3 hours a week;
• 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);
• Regular use of laxatives
• Use of antibiotics in the last 3 months
• Vegan
• Lactose intolerance
• Pregnancy or lactation
• Concomitant participation in another study

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Department of Human Biology, Maastricht University Medical Centre

Maastricht, Limburg, 6200MD, Netherlands

Location

MeSH Terms

Conditions

Obesity; Congenital Microtia; Metabolic Syndrome; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized pasteurized A. muciniphila or placebo using variable block randomization with stratification for gender and age following the weight-loss period. The procedure will be done by an independent researcher using a validated variable block randomization model in the Castor database management system (DBMS). The same independent researcher will provide the participants with the supplements, and the product (pasteurized A. muciniphila or placebo). The supplement packages will not contain information about the content. Blinding will be maintained until the analysis has been completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blind, placebo-controlled randomised intervention study

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 14, 2022
• Study Start: July 22, 2022
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

NL (1)