Effects of Akkermansia Muciniphila and Berberine Supplementation on Insulin Sensitivity in Night-shift Workers

Summary

Night shift work is associated with an increased risk of obesity, insulin resistance, and cardiometabolic disorders, largely due to circadian misalignment, disrupted sleep, and altered eating patterns. These behavioral and physiological disturbances impair glucose metabolism and are further influenced by the gut microbiota. In particular, the bacterium Akkermansia muciniphila has been linked to improved metabolic health, including enhanced insulin sensitivity, lipid regulation, and maintenance of intestinal barrier integrity. Berberine, a bioactive plant-derived compound, has demonstrated metabolic benefits, including upregulation of A. muciniphila, improvement of insulin sensitivity, and modulation of lipid metabolism.

Together, these complementary mechanisms suggest that combined A. muciniphila supplementation and berberine administration may synergistically improve metabolic health in shift workers by targeting gut microbiota composition and circadian-regulated metabolic pathways.

Based on this rationale, a double-blind, randomized, placebo-controlled, crossover study is being conducted in 200 night-shift workers from healthcare and industrial sectors in Austria and Denmark. Participants are stratified by age, sex, and work sector and randomly assigned to intervention sequences. Each participant receives either the combined supplement or placebo for 12 weeks, followed by a four-week washout, after which the alternate intervention is administered for another 12 weeks, with a total participation of 28 weeks.

Assessments are performed at four study visits and include anthropometry, body composition, blood pressure, and collection of blood, urine, and feces. Participants complete validated questionnaires on dietary intake, lifestyle, work schedules, and general health to monitor behavioral patterns throughout the study. Dietary intake is recorded for four days prior to each sampling visit in consideration of shift schedules. Sleep duration and quality are monitored via diaries and actigraphy and aligned with dietary records. Circadian variation is minimized by standardizing sampling times and implementing a fasting and synchronization period prior to visits.

The primary outcome is insulin sensitivity, measured by HOMA-IR. Secondary exploratory outcomes include gut microbiota composition and diversity, biomarkers of intestinal permeability and inflammation, lipid profiles, body composition, sleep quality, and dietary behavior.

These measures collectively provide a comprehensive evaluation of the metabolic, microbiome, and circadian effects of combined A. muciniphila and berberine supplementation in night-shift workers.

Conditions

• Obesity & Overweight
• Circadian Rhythm Disorders
• Gut Microbiota Modulation
• Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Interventions

DIETARY_SUPPLEMENT

Verum (A)

1 capsule of A. muciniphila (pasteurized, initial quantity of 10\^30 TFU, heat inactivated) and 1 capsule of 500 mg berberine hydrochloride per day.

DIETARY_SUPPLEMENT

Placebo (B)

1 capsule of A. muciniphila placebo and 1 capsule of berberine placebo (both identical to verum regarding the shape, size, colour, and matched in excipients) per day.

Sponsors & Collaborators

• Medical University of Vienna

  collaborator OTHER

• Københavns Universitet

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University of Vienna

  collaborator OTHER

• FH Joanneum Gesellschaft mbH

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-01-20

Primary Completion

2027-10-31

Completion

2028-02-29

Countries

• Austria

Study Locations