Obesity Clinical Trial
— AmansiaOfficial title:
Effect of Pasteurized Akkermansia Muciniphilia on Maintenance of Body Weight After a Low Calorie Diet
Verified date | November 2023 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Completed |
Enrollment | 90 |
Est. completion date | November 20, 2023 |
Est. primary completion date | November 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - BMI = 28 kg/m2 < 40 kg/m2 - Weight stable for at least 3 months (± 2 kg). Exclusion Criteria: - 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 ? (peroxisome proliferator-activated receptors) or PPARa (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, a-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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Human Biology, Maastricht University Medical Centre | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Physical activity | Physical activity and sedentary behavior will be monitored using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). The SQUASH measures the frequency, duration, and intensity of 4 different physical activities, namely physical activity to and from work, household activities, activities at work, and physical activities performed during free time. The higher the score, the more time is spent on physical activity. | 8 months | |
Other | Diet | Dietary intake will be monitored will be monitored using multiple 3 day weighed food diaries (food records) | 8 months | |
Primary | Body weight | Changes in body weight following the initial weight loss period will be monitored over the weight maintenance period. | 6 months | |
Secondary | Body composition | Changes in body composition following the initial weight-loss period as assessed by dual-energy X-ray absorptiometry (DEXA), and body mass index (BMI). | 8 months | |
Secondary | Body fat distribution | Changes in body fat distribution following the initial weight-loss period as assessed by the waist to hip ratio, as measured by waist and hip circumferences. | 8 months | |
Secondary | Glucose metabolism | Changes in glucose metabolism will be assessed by fasting glucose and hemoglobin A1C (HBA1c). | 8 months | |
Secondary | Insulin sensitivity | Changes in glucose and insulin responses to a 7 point oral glucose tolerance test. | 8 months | |
Secondary | Lipid profile | Changes in total cholesterol, triglycerides (TG), low-density lipoprotein) (LDL), high-density lipoprotein (HDL), and non - esterified fatty acids (NEFA) will be considered together to give an indication of the overall lipid profile as a result of the LCD and active intervention. | 8 months | |
Secondary | Adipose tissue activity | Changes in adipose tissue gene/protein expression will be assessed. | 8 months | |
Secondary | Gut barrier function | Gut barrier function will be assessed using serum/fecal zonulin, fecal calprotectin, serum LBP, and serum LPS. These measurements will be considered together to give an indication as to the function of the gut barrier, i.e. if it is normal, disrupted, or has improved as a result of the LCD and or active intervention. | 8 months | |
Secondary | Psychological well-being - mental health | Well-being, as it relates to feelings of depression and anxiety, will be measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire. | 8 months | |
Secondary | Psychological well-being - sleep quality | Well-being, as it relates to sleep and sleep quality, will be assessed using the Pittsburgh Sleep Quality Index (PSQI) | 8 months | |
Secondary | Psychological well-being - stress | Well-being, as it relates to perceived stress, will be assessed using the 10-item Perceived Stress Scale (PSS). | 8 months | |
Secondary | Psychological well-being - General | general well-being will be assessed using the 36-Item Short-Form Health Survey (Rand - 36/ SF-36) . | 8 months | |
Secondary | Gastrointestinal symptoms - bowel movements | Gastrointestinal symptoms related to bowel movement frequency and consistency will be measured using the Bristol Stool Charts (BSC). | 8 months | |
Secondary | Gastrointestinal symptoms | Gastrointestinal symptoms will be measured using the Gastrointestinal Symptom Rating Scale questionnaire. | 8 months | |
Secondary | Heart rate | Changes in heart rate will be monitored over time | 8 months | |
Secondary | Blood pressure | Changes in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) will be measured over time. | 8 months | |
Secondary | Renal function | Changes in renal function, before during, and after the LCD and intervention will be monitored with blood creatinine, sodium, potassium, and chloride concentrations. These measurements will be considered together to determine if renal function is stable, has deteriorated, or improved. | 8 months | |
Secondary | Liver function | Changes in liver function will be monitored before during and after the LCD and active intervention using blood alanine aminotransferase (ALAT), aspartate transaminase (ASAT), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), bilirubin, and, albumin. These measurements will be considered together to determine if liver function is stable, has deteriorated, or improved. | 8 months | |
Secondary | Inflammation | Inflammation will be monitored using C- reactive protein (CRP), lipopolysaccharide-binding protein (LBP), lipopolysaccharide (LPS), and serum zonulin. | 8 months | |
Secondary | Microbiota | Fecal samples to be used for analyzing microbiota composition will be collected and compared between groups. | 8 months | |
Secondary | Short chain fatty acid production | Circulating fatty acids will be measured as a measure of function of the microbiota | 8 months |
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