ObesityPhase 3FMG-01NCT03585413
Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery
A Phase 3 study testing Micronutrient-probiotic-combination in people with Obesity and Gastric Bypass, run by Bonn Education Association for Dietetics r.A., Cologne, Germany at 1 site in Germany.
Trial summary
Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese, nonalcoholic fatty liver disease (NAFLD) patients after Mini-Gastric Bypass (MGB) surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Gastric Bypass, NAFLD
- What is being tested?
- Micronutrient-probiotic-combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 31 Aug 2018to 17 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects 20-65 years old
- BMI ≥ 35 kg/m² to ≤ 50 kg/m²
- Fatty Liver Index ≥ 60
Who cannot join
- subjects with anamnestic known alcoholic-fatty liver disease, hepatitis B, hepatitis C, HIV/ AIDS
- subjects with chronic conditions such as active malignant disease, inflammatory bowel disease and other systemic inflammatory conditions
- supplementation with dietary supplements or drugs which contain probiotics, milk thistle, fatty acids, vitamins or minerals 4 weeks before bariatric surgery
- treatment with psychotropic drugs
- diabetic patients who are treated with antidiabetic medications
- use of antibiotic 4 weeks before bariatric surgery
Show all 9Show fewer
- weight gain during run-in phase of more than 5 %
- in women of childbearing age, pregnancy or breastfeeding
- no safe method of contraception in women of childbearing age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Specific Micronutrient-probiotic-combination on Fatty Liver and Cardiometabolic Status of Obese Patients After Mini-Gastric Bypass Surgery
Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese, nonalcoholic fatty liver disease (NAFLD) patients after Mini-Gastric Bypass (MGB) surgery.
Read the detailed description
Background:
The increasing prevalence of obesity and diabetes mellitus seems to reach epidemic proportions worldwide. In particular visceral obesity in combination with impaired glucose tolerance is associated with risk for progression of a broad spectrum of cardiometabolic diseases such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease and non-alcoholic fatty liver disease (NAFLD). Thus, among patients undergoing bariatric surgery more than 95% have NAFLD, with nonalcoholic steatohepatitis (NASH) being present in 32-39 %.
Only bariatric surgery currently seems to attain long-term weight loss in morbidly obese patients. In addition, greater success in terms of improvement in obesity related comorbidities and reduction of overall-mortality can be achieved by surgical measures. Recent data indicate that Mini-Gastric Bypass (MGB) is an effective procedure for weight loss and reduction of comorbidities. Although weight loss is usually recommended as therapy for obesity with NAFLD and NASH, not all NAFLD patients benefit from surgical induced weight loss as indicated by increase in transaminase activity. An optimized micronutrient in combination with a probiotic supplementation could be a useful tool to prevent the transition from NAFLD to NASH.
Aim:
Therefore this study aims to elucidate the effect of a specific micronutrient-probiotic-combination on fatty liver and insulin resistance in obese patients after MGB surgery. Furthermore, this study aims to help optimizing the dietary food supplementation after MGB to reduce the progress of NAFLD/NASH and cardiometabolic diseases.
Methods:
A randomized double blind clinical trial of 12 week dietary intervention with a specific micronutrient-probiotic-combination will be conducted in obese patients with NAFLD after standardized MGB surgery. To this end, a total of 60 patients will be randomly assigned to a specific micronutrient-probiotic-combination or micronutrient-placebo-combination group. During the preoperative 4-week run-in phase, each patient receives a formula diet to improve protein and micronutrient supply. This should align the metabolic situation within the study group. At baseline and study end blood samples are taken for further analysis of metabolic, clinical and biochemical parameters. Anthropometric data (body height, body weight, and waist circumference) and bioelectrical impedance analysis are also collected at the beginning and after 8 and 12 weeks. Fecal samples will be collected prior to surgery and after 4, 8 and 12 weeks (concomitant variable). All patients will fill out validated food intake questionnaires and stool questionnaires (frequency and consistence) after 4, 8 and 12 weeks (concomitant variable).
- Conditions
- Obesity, Gastric Bypass, NAFLD
- Being tested
- Micronutrient-probiotic-combination, Micronutrient-placebo-combination
- Keywords
- Bariatric surgery, Obesity, NAFLD, Micronutrient supplementation, Probiotic supplementation
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient-probiotic-combinationDietary supplement
Specific combined micronutrient-probiotic-supplement with different vitamins, minerals, phytochemicals and bioactive substances, and a mixture of 10 different probiotic bacteria.
Micronutrient-placebo-combinationDietary supplement
micronutrient (capsule)-placebo (powder)-supplement
| Study group | Role | What they receive |
|---|---|---|
| Specific Micronutrient-probiotic-combination | Active comparator | Intake of one micronutrient capsule three times daily and probiotic powder twice daily starting on the first day after hospital discharge until 12 weeks postoperatively.
The micronutrient capsules consist of vitamins, minerals, phytochemicals and bioactive substances. The probiotic supplement is a powder of 10 different species of probiotic bacteria. Receives: Dietary Supplement: Micronutrient-probiotic-combination |
| Micronutrient-placebo-combination | Placebo comparator | Intake of one micronutrient capsule three times daily and placebo powder twice daily starting on the first day after hospital discharge until 12 weeks postoperatively.
The micronutrient-control-combination consists of a micronutrient capsule (vitamins and minerals) but without phytochemicals and bioactive substances, and a placebo powder manufactured to mimic the probiotic powder. Receives: Dietary Supplement: Micronutrient-placebo-combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alanine-aminotransferase (ALAT) activity in serum
ALAT in U/l
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Change in Fatty Liver Index (FLI)
FLI will be calculated as: [e 0.953 x loge (triglycerides (mg/dl)) + 0.139 x BMI (kg/m²) + 0.718 x loge (GGT (U/l)) + 0.053 x waist circumference (cm) - 15.745) / (1 + e 0.953 x loge (triglycerides (mg/dl)) + 0.139 x BMI (kg/m²) + 0.718 x loge (GGT (U/l)) + 0.053 x waist circumference (cm) - 15.745)] × 100.
A FLI < 30 rules out fatty liver and a FLI > 60 rules in fatty liver.
Measured: Baseline and 12 weeks
Change in nonalcoholic fatty liver disease (NAFLD) Fibrosis Score (NFS)
NFS will be calculated as: - 1.675 + 0.037 x age (years) + 0.094 x BMI (kg/m²) + 1.13 x impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 x aspartate aminotransferase (ASAT)/ALAT ratio - 0.013 x platelet (x10^9) - 0.66 x albumin (g/dl).
NFS > 0.676 is considered to be diagnostic for the presence of significant fibrosis.
NFS < -1.455 is considered to be diagnostic fot the absence if fibrosis. NFS scores between -1.455 and 0.675 are referred as "indeterminate" scores.
Measured: Baseline and 12 weeks
Change in fasting glucose concentration
Fasting glucose in mmol/l
Measured: Baseline and 12 weeks
Change in fasting insulin concentration
Fasting insulin in pmol/l
Measured: Baseline and 12 weeks
Change in homeostatic model assessment (HOMA) of insulin resistance (IR) (HOMA-IR)
HOMA-IR will be calculated as: fasting insulin (μU/ml) x fasting glucose (mmol/l) / 22.5.
HOMA-IR > 2.77 is considered to be diagnostic for insulin resistance.
Measured: Baseline and 12 weeks
Change in glycated haemoglobin (HbA1c)
Intervention change in HbA1c level
Measured: Baseline and 12 weeks
Change in resting blood pressure
Intervention changes in resting blood pressure in mmHg
Measured: Baseline and 12 weeks
Change in heart rate
Intervention changes in heart rate in bpm
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start31 Aug 2018
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, placebo-controlled, double-blind interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonn Education Association for Dietetics r.A., Cologne, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Franziskus Hospital, University of Bonn, FormMed HealthCare AG
- Responsible party
- Principal investigator, Karl Peter Rheinwalt, Bonn Education Association for Dietetics r.A., Cologne, Germany
- Investigators
- Karl Peter Rheinwalt, MD, Principal investigator, St. Franziskus Hospital, Cologne and Bonn Education Association for Dietetics r.A., Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585413
- Sponsor's protocol ID
- BFD-02/FMG-01
- Acronym
- FMG-01
- Status last verified
- Sep 2020
- First submitted
- 7 Jun 2018
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crommen S, Rheinwalt KP, Plamper A, Rosler D, Weinhold L, Metzner C, Egert S. Prognostic Characteristics of Metabolic Dysfunction-Associated Steatotic Liver in Patients with Obesity Who Undergo One Anastomosis Gastric Bypass Surgery: A Secondary Analysis of Randomized Controlled Trial Data. Nutrients. 2024 Sep 23;16(18):3210. doi: 10.3390/nu16183210.
PubMed 39339810Crommen S, Rheinwalt KP, Plamper A, Simon MC, Rosler D, Fimmers R, Egert S, Metzner C. A Specifically Tailored Multistrain Probiotic and Micronutrient Mixture Affects Nonalcoholic Fatty Liver Disease-Related Markers in Patients with Obesity after Mini Gastric Bypass Surgery. J Nutr. 2022 Feb 8;152(2):408-418. doi: 10.1093/jn/nxab392.
PubMed 34919684
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Specific Micronutrient-probiotic-combination on Fatty Liver and Cardiometabolic Status of Obese Patients After Mini-Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT03585413
- Acronym / sponsor ID
- FMG-01 / BFD-02/FMG-01
- Conditions
- Obesity, Gastric Bypass, NAFLD
- Keywords
- Bariatric surgery, Obesity, NAFLD, Micronutrient supplementation, Probiotic supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bonn Education Association for Dietetics r.A., Cologne, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- St. Franziskus Hospital, University of Bonn, FormMed HealthCare AG
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 13 Jul 2018 (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.
Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese, nonalcoholic fatty liver disease (NAFLD) patients after Mini-Gastric Bypass (MGB) surgery.
Detailed description
Background:
The increasing prevalence of obesity and diabetes mellitus seems to reach epidemic proportions worldwide. In particular visceral obesity in combination with impaired glucose tolerance is associated with risk for progression of a broad spectrum of cardiometabolic diseases such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease and non-alcoholic fatty liver disease (NAFLD). Thus, among patients undergoing bariatric surgery more than 95% have NAFLD, with nonalcoholic steatohepatitis (NASH) being present in 32-39 %.
Only bariatric surgery currently seems to attain long-term weight loss in morbidly obese patients. In addition, greater success in terms of improvement in obesity related comorbidities and reduction of overall-mortality can be achieved by surgical measures. Recent data indicate that Mini-Gastric Bypass (MGB) is an effective procedure for weight loss and reduction of comorbidities. Although weight loss is usually recommended as therapy for obesity with NAFLD and NASH, not all NAFLD patients benefit from surgical induced weight loss as indicated by increase in transaminase activity. An optimized micronutrient in combination with a probiotic supplementation could be a useful tool to prevent the transition from NAFLD to NASH.
Aim:
Therefore this study aims to elucidate the effect of a specific micronutrient-probiotic-combination on fatty liver and insulin resistance in obese patients after MGB surgery. Furthermore, this study aims to help optimizing the dietary food supplementation after MGB to reduce the progress of NAFLD/NASH and cardiometabolic diseases.
Methods:
A randomized double blind clinical trial of 12 week dietary intervention with a specific micronutrient-probiotic-combination will be conducted in obese patients with NAFLD after standardized MGB surgery. To this end, a total of 60 patients will be randomly assigned to a specific micronutrient-probiotic-combination or micronutrient-placebo-combination group. During the preoperative 4-week run-in phase, each patient receives a formula diet to improve protein and micronutrient supply. This should align the metabolic situation within the study group. At baseline and study end blood samples are taken for further analysis of metabolic, clinical and biochemical parameters. Anthropometric data (body height, body weight, and waist circumference) and bioelectrical impedance analysis are also collected at the beginning and after 8 and 12 weeks. Fecal samples will be collected prior to surgery and after 4, 8 and 12 weeks (concomitant variable). All patients will fill out validated food intake questionnaires and stool questionnaires (frequency and consistence) after 4, 8 and 12 weeks (concomitant variable).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, placebo-controlled, double-blind interventional study
| Arm | Type | Receives |
|---|---|---|
| Specific Micronutrient-probiotic-combination | Active comparator | Dietary Supplement: Micronutrient-probiotic-combinationIntake of one micronutrient capsule three times daily and probiotic powder twice daily starting on the first day after hospital discharge until 12 weeks postoperatively. The micronutrient capsules consist of vitamins, minerals, phytochemicals and bioactive substances. The probiotic supplement is a powder of 10 different species of probiotic bacteria. |
| Micronutrient-placebo-combination | Placebo comparator | Dietary Supplement: Micronutrient-placebo-combinationIntake of one micronutrient capsule three times daily and placebo powder twice daily starting on the first day after hospital discharge until 12 weeks postoperatively. The micronutrient-control-combination consists of a micronutrient capsule (vitamins and minerals) but without phytochemicals and bioactive substances, and a placebo powder manufactured to mimic the probiotic powder. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects 20-65 years old
- BMI ≥ 35 kg/m² to ≤ 50 kg/m²
- Fatty Liver Index ≥ 60
Key exclusion criteria (9 listed)
- subjects with anamnestic known alcoholic-fatty liver disease, hepatitis B, hepatitis C, HIV/ AIDS
- subjects with chronic conditions such as active malignant disease, inflammatory bowel disease and other systemic inflammatory conditions
- supplementation with dietary supplements or drugs which contain probiotics, milk thistle, fatty acids, vitamins or minerals 4 weeks before bariatric surgery
- treatment with psychotropic drugs
- diabetic patients who are treated with antidiabetic medications
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 |
|---|---|---|
| Micronutrient-probiotic-combinationSpecific combined micronutrient-probiotic-supplement with different vitamins, minerals, phytochemicals and bioactive substances, and a mixture of 10 different probiotic bacteria. | Dietary supplement | Specific Micronutrient-probiotic-combination |
| Micronutrient-placebo-combinationmicronutrient (capsule)-placebo (powder)-supplement | Dietary supplement | Micronutrient-placebo-combination |
Primary outcome
Change in alanine-aminotransferase (ALAT) activity in serum
Time frame: Baseline and 12 weeks
ALAT in U/l
8 secondary outcomes
Change in Fatty Liver Index (FLI)
Time frame: Baseline and 12 weeks
Change in nonalcoholic fatty liver disease (NAFLD) Fibrosis Score (NFS)
Time frame: Baseline and 12 weeks
Change in fasting glucose concentration
Time frame: Baseline and 12 weeks
Change in fasting insulin concentration
Time frame: Baseline and 12 weeks
Change in homeostatic model assessment (HOMA) of insulin resistance (IR) (HOMA-IR)
Time frame: Baseline and 12 weeks
Change in glycated haemoglobin (HbA1c)
Time frame: Baseline and 12 weeks
Change in resting blood pressure
Time frame: Baseline and 12 weeks
Change in heart rate
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Derived from this study: PubMed 39339810Crommen S, Rheinwalt KP, Plamper A, Rosler D, Weinhold L, Metzner C, Egert S. Prognostic Characteristics of Metabolic Dysfunction-Associated Steatotic Liver in Patients with Obesity Who Undergo One Anastomosis Gastric Bypass Surgery: A Secondary Analysis of Randomized Controlled Trial Data. Nutrients. 2024 Sep 23;16(18):3210. doi: 10.3390/nu16183210.
- Derived from this study: PubMed 34919684Crommen S, Rheinwalt KP, Plamper A, Simon MC, Rosler D, Fimmers R, Egert S, Metzner C. A Specifically Tailored Multistrain Probiotic and Micronutrient Mixture Affects Nonalcoholic Fatty Liver Disease-Related Markers in Patients with Obesity after Mini Gastric Bypass Surgery. J Nutr. 2022 Feb 8;152(2):408-418. doi: 10.1093/jn/nxab392.
- 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. This study is not recruiting at the moment.
Karl Peter Rheinwalt, MD principal investigator
St. Franziskus Hospital, Cologne and Bonn Education Association for Dietetics r.A., Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micronutrient-probiotic-combination in people with Obesity and Gastric Bypass, run by Bonn Education Association for Dietetics r.A., Cologne, Germany at 1 site in Germany.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 25 Sep 2020. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alanine-aminotransferase (ALAT) activity in serum (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585413, which also lists 2 linked publications.
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 25 Sep 2020.