Akkermansia muciniphila plus berberine to improve insulin sensitivity in night-shift workers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.