Overweight and ObesityCARMANCT04561284
Carbohydrate-induced Resilience of the Gut Microbiome After Antibiotics Use
A study testing Indigestible fiber (classified) in people with Overweight and Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The gut microbiome is a complex ecosystem with a wide range of functions, and it is thought that it can influence multiple processes in the human body. In turn, the composition and activity of the gut microbiome is affected by many factors as well. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Insulin Resistance, Dysbiosis
- What is being tested?
- Indigestible fiber (classified)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2020to 21 Oct 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese (BMI: 25 - 35 kg/m^2)
- Caucasian
- Stable body weight (< 3 kg change) for the last 3 months
Who cannot join
- Known allergic reaction to vancomycin or other glycopeptide antibiotics;
- Pre-diabetes, diabetes mellitus, cardiovascular disease, kidney disease, hearing disorders, cancer, asthma or bronchitis, liver malfunction, diseases affecting glucose tolerance, major illness with a life expectancy < 5 years, gastrointestinal disease or abdominal surgery;
- Abuse of products; alcohol and drugs, excessive nicotine use (> 20 cigarettes per day);
- Regular use of laxation products;
- Use of antibiotics in the past 3 months;
- Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
Show all 11Show fewer
- Plans to lose weight or currently following a hypocaloric diet;
- Following a vegetarian diet;
- Participation in organized sports activities for > 3 hours per week;
- Suffering from hearing loss or other hearing problems;
- Currently pregnant, planning to become pregnant, or currently breastfeeding.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Human Biology, Maastricht University Medical Centre
Maastricht, 6200MD
About this study
The gut microbiome is a complex ecosystem with a wide range of functions, and it is thought that it can influence multiple processes in the human body. In turn, the composition and activity of the gut microbiome is affected by many factors as well.
Antibiotics can be very effective in treating bacterial infections, but they are also associated with detrimental health effects. Previous studies have already shown that antibiotics disturb the human gut microbiome composition by destroying commensal bacteria. As it is well known that the microbiome influences host metabolism, perturbation of the healthy microbiome (dysbiosis) is thought to be disease causing.
Read more
Prebiotics, on the other hand, are beneficial for the gut microbiome. These so-called indigestible fibers are naturally present in our foods, but cannot be metabolised by the human body. Many bacteria in the human gut are able to ferment these fibers and they subsequently produce beneficial products for the rest of the body. Besides this, fiber intake stimulates growth of commensal bacteria in the human gut.
Although it has become increasingly clear that prebiotics have a beneficial effect on the gut microbiome and general health, it is still unclear to which extent the beneficial effects of prebiotics supplementation occur after the gut microbiome is disturbed by antibiotics. We hypothesize that prebiotic supplementation after antibiotics use will improve restoration of the gut microbiome to a healthy state compared to placebo.
Read the detailed description
In this double-blind, randomized placebo-controlled study, 40 overweight, but otherwise healthy adults will first receive vancomycin for 7 days (3x 500mg per day) to disturb the gut microbiome. They will then receive either indigestible fiber supplementation (classified) ór a placebo for the following 8 weeks. All study parameters will be assessed in two parallel groups, to which subjects will be assigned using minimization.
After initial screening, participants will be asked to visit the university for a total of 6 times during a period of 11 weeks. A clinical investigation day will take place at baseline, after antibiotics use and after the supplementation period. The remaining 3 visits will be short visits during the supplementation period (week 2, 4 \& 6 of supplementation). Participants will be asked to collect feces every day before the university visits.
During the clinical investigation days, an abdominal subcutaneous adipose tissue will be taken under fasting conditions. Participants will also perform a 7-point oral glucose tolerance test to assess their insulin sensitivity. Furthermore, blood samples will be taken in the fasted state to assess markers of fat metabolism, short-chain fatty acids, gut hormones and inflammatory markers. Participants will be asked to hand in collected feces and to fill in questionnaires regarding stool consistency, stool frequency and physical activity. Lastly, they will be asked to hand in filled-in 3-day food diaries.
On the 3 remaining visits during the supplementation period, participants will hand in collected feces and food diaries, and fill in the questionnaires.
For these 6 visits, participants will have to invest approximately 14 hours.
- Conditions
- Overweight and Obesity, Insulin Resistance, Dysbiosis
- Being tested
- Indigestible fiber (classified), Placebo
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigestible fiber (classified)Dietary supplement
Participants will be asked to ingest 12 grams of indigestible fiber powder per day for a period of 8 weeks. Three times daily, they will take 4 grams of powder with their meal.
PlaceboDietary supplement
Participants will be asked to ingest 6 grams of placebo powder per day for a period of 8 weeks. Three times daily, they will take 2 grams of powder with their meal.
| Study group | Role | What they receive |
|---|---|---|
| Indigestible fiber supplementation | Experimental | Participants will receive an indigestible fiber supplementation (classified) for a period of 8 weeks. Thrice daily, they will take the fiber powder during their meals. Receives: Dietary Supplement: Indigestible fiber (classified) |
| Placebo supplementation | Placebo comparator | Participants will receive placebo supplementation (Maltodextrin) for a period of 8 weeks. Thrice daily, they will take the fiber powder during their meals. The amount of maltodextrin taken will be isocaloric with the amount of indigestible fiber. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Microbial DNA will be extracted, and microbiota composition will be analyzed by next-generation sequencing.
Gut microbiota composition at week 1 will be compared with baseline to assess the effect of antibiotic use. Microbial composition during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess restorative potential of the indigestible fiber.
Measured: Change in gut microbiota composition after antibiotic use (week 1) compared to baseline & change in microbial composition during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Gut microbiota activity
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Microbial proteins will be analyzed by mass spectrometry (MS) after extraction.
Gut microbiota activity at week 1 will be compared with baseline to assess the effect of antibiotic use. Microbial activity during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess restorative potential of the indigestible fiber.
Measured: Change in gut microbiota activity after antibiotic use (week 1) compared to baseline & change in microbial activity during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Fecal Short-Chain Fatty Acids (SCFA)
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Fecal SCFA levels will be analyzed using gas-chromatography MS.
Fecal SCFA levels at week 1 will be compared with baseline levels to assess the effect of antibiotic use. SCFA levels in feces during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess restorative potential of the indigestible fiber.
Measured: Change in fecal SCFA levels after antibiotic use (week 1) compared to baseline & change in fecal SCFA levels during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Resistome analysis
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Microbial DNA will be extracted, and resistome analysis will be performed via qPCR, targeting specific antibiotic resistance genes (ARG).
Presence of ARG at week 1 will be compared with baseline to assess the effect of antibiotic use. ARG presence during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess the effect of the indigestible fiber.
Measured: Change in ARG presence after antibiotic use (week 1) compared to baseline & change in ARG presence during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Secondary outcomes (8)
Body Mass Index
At the clinical investigation days (baseline, week 1 and week 9), Body Mass Index will be measured.
Measured: Change in BMI after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Insulin sensitivity
At the 3 clinical investigation days, a 7-point oral glucose tolerance test will be performed to assess insulin sensitivity. Glucose and insulin levels in the blood will be measured, and HOMA-IR will be calculated.
Measured: Change in insulin sensitivity after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Plasma markers of fat metabolism
At the 3 clinical investigation days, blood will be drawn in the fasted state to analyze plasma Free Fatty Acid and Triacylglycerol levels.
Measured: Change in markers of fat metabolism after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Adipose tissue gene expression
At the 3 clinical investigation days, an abdominal subcutaneous adipose tissue biopsy will be taken to investigate adipose tissue gene expression. Expression of genes of interest will be analysed using targeted qPCR.
Measured: Change in adipose tissue gene expression after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Adipose tissue protein levels
At the 3 clinical investigation days, an abdominal subcutaneous adipose tissue biopsy will be taken to investigate adipose tissue protein levels. Proteins of interest will be analysed using Western Blot.
Measured: Change in adipose tissue protein levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Plasma short chain fatty acids
At the 3 clinical investigation days, blood will be drawn in the fasted state to analyse levels of the SCFA acetate, butyrate and propionate.
Measured: Change in plasma SCFA levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Inflammatory markers
At the 3 clinical investigation days, blood will be drawn in the fasted state to analyse levels of the inflammatory markers IL-6, IL-8, MCP1, TNF-alpha, leptin, adiponectin and LBP.
Measured: Change in plasma inflammatory marker levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Gut hormones
At the 3 clinical investigation days, blood will be drawn in the fasted state to analyse levels of the gut hormones GLP-1 and PYY.
Measured: Change in plasma gut hormone levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Nov 2020
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen E Blaak, Prof. Dr., Principal investigator, Department of Human Biology, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561284
- Sponsor's protocol ID
- NL73140.068.20 / METC20-025
- Acronym
- CARMA
- Status last verified
- Dec 2022
- First submitted
- 8 Sep 2020
- Last updated
- 28 Dec 2022
- 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 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate-induced Resilience of the Gut Microbiome After Antibiotics Use
- ClinicalTrials.gov ID
- NCT04561284
- Acronym / sponsor ID
- CARMA / NL73140.068.20 / METC20-025
- Conditions
- Overweight and Obesity, Insulin Resistance, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 23 Sep 2020 (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.
The gut microbiome is a complex ecosystem with a wide range of functions, and it is thought that it can influence multiple processes in the human body. In turn, the composition and activity of the gut microbiome is affected by many factors as well.
Antibiotics can be very effective in treating bacterial infections, but they are also associated with detrimental health effects. Previous studies have already shown that antibiotics disturb the human gut microbiome composition by destroying commensal bacteria. As it is well known that the microbiome influences host metabolism, perturbation of the healthy microbiome (dysbiosis) is thought to be disease causing.
Prebiotics, on the other hand, are beneficial for the gut microbiome. These so-called indigestible fibers are naturally present in our foods, but cannot be metabolised by the human body. Many bacteria in the human gut are able to ferment these fibers and they subsequently produce beneficial products for the rest of the body. Besides this, fiber intake stimulates growth of commensal bacteria in the human gut.
Although it has become increasingly clear that prebiotics have a beneficial effect on the gut microbiome and general health, it is still unclear to which extent the beneficial effects of prebiotics supplementation occur after the gut microbiome is disturbed by antibiotics. We hypothesize that prebiotic supplementation after antibiotics use will improve restoration of the gut microbiome to a healthy state compared to placebo.
Detailed description
In this double-blind, randomized placebo-controlled study, 40 overweight, but otherwise healthy adults will first receive vancomycin for 7 days (3x 500mg per day) to disturb the gut microbiome. They will then receive either indigestible fiber supplementation (classified) ór a placebo for the following 8 weeks. All study parameters will be assessed in two parallel groups, to which subjects will be assigned using minimization.
After initial screening, participants will be asked to visit the university for a total of 6 times during a period of 11 weeks. A clinical investigation day will take place at baseline, after antibiotics use and after the supplementation period. The remaining 3 visits will be short visits during the supplementation period (week 2, 4 \& 6 of supplementation). Participants will be asked to collect feces every day before the university visits.
During the clinical investigation days, an abdominal subcutaneous adipose tissue will be taken under fasting conditions. Participants will also perform a 7-point oral glucose tolerance test to assess their insulin sensitivity. Furthermore, blood samples will be taken in the fasted state to assess markers of fat metabolism, short-chain fatty acids, gut hormones and inflammatory markers. Participants will be asked to hand in collected feces and to fill in questionnaires regarding stool consistency, stool frequency and physical activity. Lastly, they will be asked to hand in filled-in 3-day food diaries.
On the 3 remaining visits during the supplementation period, participants will hand in collected feces and food diaries, and fill in the questionnaires.
For these 6 visits, participants will have to invest approximately 14 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indigestible fiber supplementation | Experimental | Dietary Supplement: Indigestible fiber (classified)Participants will receive an indigestible fiber supplementation (classified) for a period of 8 weeks. Thrice daily, they will take the fiber powder during their meals. |
| Placebo supplementation | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive placebo supplementation (Maltodextrin) for a period of 8 weeks. Thrice daily, they will take the fiber powder during their meals. The amount of maltodextrin taken will be isocaloric with the amount of indigestible fiber. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight or obese (BMI: 25 - 35 kg/m^2)
- Caucasian
- Stable body weight (< 3 kg change) for the last 3 months
Key exclusion criteria (11 listed)
- Known allergic reaction to vancomycin or other glycopeptide antibiotics;
- Pre-diabetes, diabetes mellitus, cardiovascular disease, kidney disease, hearing disorders, cancer, asthma or bronchitis, liver malfunction, diseases affecting glucose tolerance, major illness with a life expectancy < 5 years, gastrointestinal disease or abdominal surgery;
- Abuse of products; alcohol and drugs, excessive nicotine use (> 20 cigarettes per day);
- Regular use of laxation products;
- Use of antibiotics in the past 3 months;
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 |
|---|---|---|
| Indigestible fiber (classified)Participants will be asked to ingest 12 grams of indigestible fiber powder per day for a period of 8 weeks. Three times daily, they will take 4 grams of powder with their meal. | Dietary supplement | Indigestible fiber supplementation |
| PlaceboParticipants will be asked to ingest 6 grams of placebo powder per day for a period of 8 weeks. Three times daily, they will take 2 grams of powder with their meal. | Dietary supplement | Placebo supplementation |
Primary outcome
Gut microbiota composition
Time frame: Change in gut microbiota composition after antibiotic use (week 1) compared to baseline & change in microbial composition during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Microbial DNA will be extracted, and microbiota composition will be analyzed by next-generation sequencing. Gut microbiota composition at week 1 will be compared with baseline to assess the effect of antibiotic use. Microbial composition during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess restorative potential of the indigestible fiber.
Gut microbiota activity
Time frame: Change in gut microbiota activity after antibiotic use (week 1) compared to baseline & change in microbial activity during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Microbial proteins will be analyzed by mass spectrometry (MS) after extraction. Gut microbiota activity at week 1 will be compared with baseline to assess the effect of antibiotic use. Microbial activity during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess restorative potential of the indigestible fiber.
Fecal Short-Chain Fatty Acids (SCFA)
Time frame: Change in fecal SCFA levels after antibiotic use (week 1) compared to baseline & change in fecal SCFA levels during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Fecal SCFA levels will be analyzed using gas-chromatography MS. Fecal SCFA levels at week 1 will be compared with baseline levels to assess the effect of antibiotic use. SCFA levels in feces during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess restorative potential of the indigestible fiber.
Resistome analysis
Time frame: Change in ARG presence after antibiotic use (week 1) compared to baseline & change in ARG presence during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.
Fecal samples will be collected at baseline, week 1, 3, 5, 7 and 9. Microbial DNA will be extracted, and resistome analysis will be performed via qPCR, targeting specific antibiotic resistance genes (ARG). Presence of ARG at week 1 will be compared with baseline to assess the effect of antibiotic use. ARG presence during the supplementation period (week 3, 5, 7 \& 9) will be compared between the two study arms to assess the effect of the indigestible fiber.
8 secondary outcomes
Body Mass Index
Time frame: Change in BMI after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Insulin sensitivity
Time frame: Change in insulin sensitivity after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Plasma markers of fat metabolism
Time frame: Change in markers of fat metabolism after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Adipose tissue gene expression
Time frame: Change in adipose tissue gene expression after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Adipose tissue protein levels
Time frame: Change in adipose tissue protein levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Plasma short chain fatty acids
Time frame: Change in plasma SCFA levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Inflammatory markers
Time frame: Change in plasma inflammatory marker levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
Gut hormones
Time frame: Change in plasma gut hormone levels after 1 week of antibiotic use compared to baseline & after 8-week indigestible fiber supplementation compared to placebo.
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 28 Dec 2022.
- 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.
Ellen E Blaak, Prof. Dr. principal investigator
Department of Human Biology, Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indigestible fiber (classified) in people with Overweight and Obesity and Insulin Resistance, run by Maastricht University Medical Center at 1 site in Netherlands.
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 11 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 28 Dec 2022. 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 Netherlands. 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.
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?
Gut microbiota composition (time frame: Change in gut microbiota composition after antibiotic use (week 1) compared to baseline & change in microbial composition during fiber supplementation (week 3, 5, 7 & 9) compared to placebo.). The study lists 4 primary outcomes in all. 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 28 Dec 2022.