Obesity & OverweightShift2HealthNCT07440147
Effects of Akkermansia Muciniphila and Berberine Supplementation on Insulin Sensitivity in Night-shift Workers
A study testing Verum (A) in people with Obesity & Overweight and Circadian Rhythm Disorders, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Circadian Rhythm Disorders, Gut Microbiota Modulation
- What is being tested?
- Verum (A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 20 Jan 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
FH JOANNEUM University of Applied Sciences
Graz, Styria, 8020
Miriam Ressler, PhD, +4331654536677, miriam.ressler@fh-joanneum.at
About this study
Official title: 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
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.
Read more
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)
- Being tested
- Verum (A), Placebo (B)
- Medical subject headings
- Obesity, Overweight, Chronobiology Disorders, Prediabetic State, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum (A)Dietary supplement
1 capsule of A. muciniphila (pasteurized, initial quantity of 10^30 TFU, heat inactivated) and 1 capsule of 500 mg berberine hydrochloride per day.
Placebo (B)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| AB Group | Experimental | Participants will first receive Verum (A) for 3 months. After a 4-week washout period, they will receive Placebo (B) for 3 months. Receives: Dietary Supplement: Verum (A); Dietary Supplement: Placebo (B) |
| BA Group | Experimental | Participants will first receive Placbo (B) for 3 months. After a 4-week washout period, they will receive Verum (A) for 3 months. Receives: Dietary Supplement: Verum (A); Dietary Supplement: Placebo (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 3-months supplementation with A. muciniphila and berberine on insulin resistance using HOMA-IR compared to placebo
Homeostasis Model Assessment of Insulin Resistance, calculated as (fasting insulin (μU/ml) x fasting glucose (mmol/l)) / 22.5, will be assessed to calculate the change between baseline and endpoint in the two periods
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Secondary outcomes (12)
Change in gut microbiom composition between the baseline and endpoint change in the two periods
Gene sequencing of the 16S rRNA is performed on the stool samples to compare microbiota diversity and relative abundance
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in FABPi between the baseline and endpoint change in the two periods
Measurement of FABP intestinal (FABPi) in blood (pg/mL)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in zonulin between the baseline and endpoint change in the two periods
Measurement of zonulin in blood (ng/mL)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in LPB between the baseline and endpoint change in the two periods
Measurement of lipopolysaccharide-binding protein (LPB) in blood (pg/mL)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in CRP between the baseline and endpoint change in the two periods
Analysis of high-sensitive C-reactive protein (hs-CRP, mg/L) in blood
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in stool short-chain fatty acids (SCFA) between the baseline and endpoint change in the two periods
SCFA will be extracted and quantitatively analysed by GC-MS (µmol/g)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in blood lipid profile and cardiovascular markers between the baseline and endpoint change in the two periods
Measurement of cholesterol (mmol/L), low-density lipoprotein cholesterol (LDL-C, mmol/L), high-density lipoprotein (HDL-C, mmol/L), and triglyceride levels (TG, mmol/L) in blood
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in blood pressure between the baseline and endpoint change in the two periods
Systolic BP (mmHG) and diastolic BP (mmHG)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in melatonin between the baseline and endpoint change in the two periods
6-sulfatoxymelatonin in urine (µg/L)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in BMI between the baseline and endpoint change in the two periods
Body mass index (BMI)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in body composition between the baseline and endpoint change in the two periods
Bioelectrical Impedance Analysis (BIA)
Measured: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in metabolomics at the end of the two periods
Metabolomic profiles obtained with LC-MS/MS
Measured: At the beginning and the end of each intervention period (week 12, week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start20 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FH Joanneum Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna, Københavns Universitet, Erasmus Medical Center, University of Vienna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440147
- Sponsor's protocol ID
- 1306/2025
- Other IDs
- 101080788
- Acronym
- Shift2Health
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07440147
- Acronym / sponsor ID
- Shift2Health / 1306/2025
- Conditions
- Obesity & Overweight, Circadian Rhythm Disorders, Gut Microbiota Modulation, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- FH Joanneum Gesellschaft mbHIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna, Københavns Universitet, Erasmus Medical Center, University of Vienna
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB Group | Experimental | Dietary Supplement: Verum (A), Dietary Supplement: Placebo (B)Participants will first receive Verum (A) for 3 months. After a 4-week washout period, they will receive Placebo (B) for 3 months. |
| BA Group | Experimental | Dietary Supplement: Verum (A), Dietary Supplement: Placebo (B)Participants will first receive Placbo (B) for 3 months. After a 4-week washout period, they will receive Verum (A) for 3 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | AB Group, BA Group |
| 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. | Dietary supplement | AB Group, BA Group |
Primary outcome
Change of 3-months supplementation with A. muciniphila and berberine on insulin resistance using HOMA-IR compared to placebo
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Homeostasis Model Assessment of Insulin Resistance, calculated as (fasting insulin (μU/ml) x fasting glucose (mmol/l)) / 22.5, will be assessed to calculate the change between baseline and endpoint in the two periods
12 secondary outcomes
Change in gut microbiom composition between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in FABPi between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in zonulin between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in LPB between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in CRP between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in stool short-chain fatty acids (SCFA) between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in blood lipid profile and cardiovascular markers between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in blood pressure between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in melatonin between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in BMI between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in body composition between the baseline and endpoint change in the two periods
Time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)
Change in metabolomics at the end of the two periods
Time frame: At the beginning and the end of each intervention period (week 12, week 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum (A) in people with Obesity & Overweight and Circadian Rhythm Disorders, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Ressler, PhD (+4331654536677, miriam.ressler@fh-joanneum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 3-months supplementation with A. muciniphila and berberine on insulin resistance using HOMA-IR compared to placebo (time frame: At the beginning and the end of each intervention period (week 0, 12, 16, 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.