Akkermansia muciniphila plus berberine to improve insulin sensitivity in night-shift workers
Effects of Akkermansia Muciniphila and Berberine Supplementation on Insulin Sensitivity in Night-shift Workers: a Double-blind, Randomised, Placebo-controlled, Crossover Study Within the Shift2Health Project
This trial tests whether taking Akkermansia muciniphila together with berberine can improve insulin sensitivity in people who work regular night shifts and have overweight or prediabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | FH Joanneum Gesellschaft mbH Industry-sponsored |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT07440147 on ClinicalTrials.gov |
What this trial studies
Night-shift workers with overweight or impaired glucose regulation are given either a combination of A. muciniphila supplementation plus berberine or a matching placebo, and metabolic and gut-microbiome measures are compared before and after the intervention. The protocol focuses on participants who have done night shifts for several years and perform multiple night shifts per month. Outcomes include measures of insulin sensitivity, other metabolic markers, and changes in gut microbiota composition. The trial is conducted at FH JOANNEUM in Graz with collaborators from Medical University of Vienna, Københavns Universitet, and Erasmus Medical Center.
Who should consider this trial
Good fit: Ideal candidates are adult healthcare or industrial workers who do at least 24 hours/week of current night-shift work (including ≥3 hours between 00:00–05:00), have worked night shifts for more than 3 years with at least 4 night shifts per month, and have overweight or prediabetes but not diagnosed diabetes.
Not a fit: People with diagnosed type 1 or type 2 diabetes, BMI ≥ 40 kg/m², recent or planned major surgery, uncontrolled thyroid disease, major chronic illnesses (e.g., renal failure, active hepatitis, cirrhosis, recent MI or stroke), or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could improve insulin sensitivity and other metabolic measures in night-shift workers, potentially lowering their risk of diabetes and cardiometabolic disease.
How similar studies have performed: Animal studies and some small human trials have shown metabolic benefits from A. muciniphila or berberine separately, but combined supplementation in night-shift workers is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Health care or industrial shift worker * Employed or self-employed working ≥ 24 h/week * Current night shift work (night shift defined as a work schedule that includes at least 3 hours of work between 00:00 and 5:00) with at least 2 consecutive nights/month * Night shift work duration \> 3 years * 4 or more night shifts/month Exclusion Criteria: * BMI of 40 kg/m² or higher * Pregnancy or planned pregnancy within 6 months of enrolment or breastfeeding women * Bariatric surgery * Surgery in the 3 months prior to the study or planned surgery in the next 6 months that, in the opinion of the investigators, could potentially affect the outcome of the study * Diagnosed diabetes type 1 or type 2 * Uncontrolled thyroid disease (confirmed by clinically significant abnormal TSH/T4 levels without stable medication for more than 3 months) * Chronic diseases (renal failure, active hepatitis, liver cirrhosis, myocardial infarction within the last 2 years, stroke, chronic obstructive pulmonary disease or cancer) * Immunodeficiency syndrome, active autoimmune or autoinflammatory disease (e.g. multiple sclerosis, lupus, rheumatoid arthritis), inflammatory bowel disease (e.g. IBS or ulcerative colitis) and acute episodes of atopic diseases (atopic dermatitis, asthma, type 1 allergies such as hay fever). Grave's disease, Hashimoto thyroiditis, Celiac disease, sarcoidosis, Lichen planus, are allowed, if well treated and stable * Regular intake of anticoagulants * Known allergy to any inactive or active ingredients in the study products * Participation in other clinical intervention trials during the study * Current or planned participation in a weight loss program (including intermittent fasting), extreme diet, or vigorous exercise (e.g., running, fast cycling, swimming laps, or playing intense sports that quickly raise your heart rate)
Where this trial is running
Graz, Styria
- FH JOANNEUM University of Applied Sciences — Graz, Styria, Austria (Recruiting)
Study contacts
- Study coordinator: Miriam Ressler, PhD
- Email: miriam.ressler@fh-joanneum.at
- Phone: +4331654536677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.