ObesityDUPLONCT03075228
Comparison of the Microbial Composition in Lean and Obese Subjects
An observational study of Obesity, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
Rationale: The microbial composition in the small intestine (SI) differs largely from the composition in feces. Many physiological processes related to health, such as immunoregulation and metabolic programming, mainly take place in the SI. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- IntelliCap
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Apr 2017to 4 Jul 2017
- Phase
- Observational
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Ten (10) apparently healthy lean female subjects, as well as ten (10) apparently healthy obese female subjects, all aged 25-50y, will be recruited locally/regionally from the general population.
Who may be able to join
- Female;
- Age: 25-50y;
- Lean: BMI 19-23 kg/m2, waist circumference <80 cm, and fasting glucose <6.1 mmol/L; Obese: BMI 30-35 kg/m2, waist circumference >88 cm, and fasting glucose >=6.1 and <7.5 mmol/L;
- Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid");
- Healthy as assessed by results of the pre-study safety laboratory tests (clinical chemistry: liver/kidney function etc);
- Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day);
- Regular bowel movement (defecation on average once a day, at least 4 times/week).
Who cannot join
- Participation in any clinical trial with oral, intravenous or inhalatory administration of any substances during 90 days before study start;
- History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study:
- type 1 or type 2 diabetes;
- gastrointestinal disease;
- bariatric surgery;
- cardiovascular disease, liver or renal failure or disease of the thyroid gland, cancer;
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- infectious disease, history of chronic active inflammatory disorders or food allergy;
- Use of antibiotics during the one (1) year prior to study start; #
- Constipation/infrequent bowel movement (defecation <4 times per week);
- Having diarrhea within 3 months prior to the study start (at least 3 loose stools per day);
- Use of laxatives, fiber supplements (e.g. lactulose, inulin), glucose lowering drugs, insulin, anti-obesity drugs, immunosuppressive drugs (e.g. systemic corticosteroids, cyclosporine, azathioprine, antibodies) during the three (3) months prior to study start;
- Use of temporary or irregular medication for diabetes, dyslipidemia or hypertension;
- Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, H2 receptor antagonists, proton pump inhibitors, analgesics, herbal remedies or anti-inflammatory drugs (e.g. NSAIDs) during the three (3) weeks prior to study start;
- Use of probiotics or prebiotics during the three (3) months prior to study start;
- Mental status that is incompatible with the proper conduct of the study;
- Presence of swallowing or passage disorder;
- Carrying a pacemaker or any other (implanted) medical electronic device;
- Scheduled for an MRI scan during the study period;
- Not willing to have an X-ray if the capsule is not recovered from the faeces;
- Alcohol consumption > 15 units/week and >3/day. In case of less alcohol consumption: not willing to stop during the study;
- Drug abuse, and not willing/able to stop this during the study;
- Heavy exercise or sports training > 10 hours/week;
- Smoking;
- Active or recent participation in a weight loss program including weight change (increase or loss) of >3 kg during the last three (3) months;
- Reported unexplained weight loss or weight gain of > 5 kg in the year prior to pre-study screening;
- Reported slimming or medically prescribed diet;
- Reported special diets;
- Pregnant or planning to become pregnant during the study, breastfeeding ;
- Postmenopausal women on unstable hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DUPLO Study: Comparison of the Microbial Composition of the Upper Gastrointestinal Tract in Lean and Obese Subjects
Rationale: The microbial composition in the small intestine (SI) differs largely from the composition in feces. Many physiological processes related to health, such as immunoregulation and metabolic programming, mainly take place in the SI. Therefore, the SI, from a microbiota perspective, is as relevant as the large intestine. There are indications that microbiota composition is different in lean and obese subjects, and is related to insulin resistance. However, these indications are mainly based on the analysis of fecal samples. Therefore, analysis of the microbiota composition in the more proximal part of the gastrointestinal (GI) tract may provide new insights into the microbial species that are involved or related to metabolic homeostasis at that location. The IntelliCap® CR system offers a minimally invasive tool that is able to collect reliable samples in the SI, as was shown by NIZO in a clinical validation study. The main aim of the current study is to explore and compare the upper GI microbiota composition in lean and obese subjects, in order to generate new leads for development of products that may target the upper GI microbiota community or specific species thereof, which may impact the maintenance of metabolic homeostasis. This may provide new opportunities for the treatment, reduction or prevention of overweight and/or obesity or insulin resistance.
- Conditions
- Obesity
- Being tested
- IntelliCap
- Keywords
- microbiota, small intestine, metabolic disease
- Medical subject headings
- Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliCapDevice
Sampling of the small intestine using a samling capsule.
| Study group | Role | What they receive |
|---|---|---|
| Lean subjects | Lean is defined as having a BMI of 19-23 kg/m2, waist circumference <80 cm and fasting glucose levels <6.1 mmol/L. Receives: Device: IntelliCap | |
| Obese subjects | Obese is defined as having a BMI of 30-35 kg/m2, waist circumference >88 cm and fasting glucose levels >=6.1 and <7.5 mmol/L Receives: Device: IntelliCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition
Relative abundance of microbiota species (% of total) in the small intestine in lean vs obese subjects
Measured: 3 days after consuming a fully controlled western style diet
Secondary outcomes (3)
Total bacterial count
Total bacterial count measured by qPCR in the small intestinal samples in lean vs obese subjects
Measured: 3 days after consuming a fully controlled western style diet
Cytokine levels
Cytokines levels in blood in relation to microbiota composition in lean vs obese subjects
Measured: 3 days after consuming a fully controlled western style diet
Metabolic markers
Glucose, insulin and cholesterol levels in blood in relation to microbiota composition in lean vs obese subjects
Measured: 3 days after consuming a fully controlled western style diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start25 Apr 2017
- Primary completion4 Jul 2017
- Study completion4 Jul 2017
Why it stopped: Low recruitment rate; high proportion of screening failures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco Sweeteners Oy
- Responsible party
- Sponsor
- Investigators
- Els van Hoffen, PhD, Principal investigator, NIZO food research BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075228
- Sponsor's protocol ID
- NL 59327.081.16
- Acronym
- DUPLO
- Status last verified
- Jul 2017
- First submitted
- 6 Mar 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUPLO Study: Comparison of the Microbial Composition of the Upper Gastrointestinal Tract in Lean and Obese Subjects
- ClinicalTrials.gov ID
- NCT03075228
- Acronym / sponsor ID
- DUPLO / NL 59327.081.16
- Conditions
- Obesity
- Keywords
- microbiota, small intestine, metabolic disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment rate; high proportion of screening failures.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- Danisco Sweeteners Oy
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 9 Mar 2017 (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.
Rationale: The microbial composition in the small intestine (SI) differs largely from the composition in feces. Many physiological processes related to health, such as immunoregulation and metabolic programming, mainly take place in the SI. Therefore, the SI, from a microbiota perspective, is as relevant as the large intestine. There are indications that microbiota composition is different in lean and obese subjects, and is related to insulin resistance. However, these indications are mainly based on the analysis of fecal samples. Therefore, analysis of the microbiota composition in the more proximal part of the gastrointestinal (GI) tract may provide new insights into the microbial species that are involved or related to metabolic homeostasis at that location. The IntelliCap® CR system offers a minimally invasive tool that is able to collect reliable samples in the SI, as was shown by NIZO in a clinical validation study. The main aim of the current study is to explore and compare the upper GI microbiota composition in lean and obese subjects, in order to generate new leads for development of products that may target the upper GI microbiota community or specific species thereof, which may impact the maintenance of metabolic homeostasis. This may provide new opportunities for the treatment, reduction or prevention of overweight and/or obesity or insulin resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean subjects | – | Device: IntelliCapLean is defined as having a BMI of 19-23 kg/m2, waist circumference <80 cm and fasting glucose levels <6.1 mmol/L. |
| Obese subjects | – | Device: IntelliCapObese is defined as having a BMI of 30-35 kg/m2, waist circumference >88 cm and fasting glucose levels >=6.1 and <7.5 mmol/L |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Ten (10) apparently healthy lean female subjects, as well as ten (10) apparently healthy obese female subjects, all aged 25-50y, will be recruited locally/regionally from the general population.
Key inclusion criteria (7 listed)
- Female;
- Age: 25-50y;
- Lean: BMI 19-23 kg/m2, waist circumference <80 cm, and fasting glucose <6.1 mmol/L; Obese: BMI 30-35 kg/m2, waist circumference >88 cm, and fasting glucose >=6.1 and <7.5 mmol/L;
- Healthy as assessed by the NIZO lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid");
- Healthy as assessed by results of the pre-study safety laboratory tests (clinical chemistry: liver/kidney function etc);
Key exclusion criteria (29 listed)
- Participation in any clinical trial with oral, intravenous or inhalatory administration of any substances during 90 days before study start;
- History or presence of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study:
- Use of antibiotics during the one (1) year prior to study start; #
- Constipation/infrequent bowel movement (defecation <4 times per week);
- Having diarrhea within 3 months prior to the study start (at least 3 loose stools per day);
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 |
|---|---|---|
| IntelliCapSampling of the small intestine using a samling capsule. | Device | Lean subjects, Obese subjects |
Primary outcome
Microbiota composition
Time frame: 3 days after consuming a fully controlled western style diet
Relative abundance of microbiota species (% of total) in the small intestine in lean vs obese subjects
3 secondary outcomes
Total bacterial count
Time frame: 3 days after consuming a fully controlled western style diet
Cytokine levels
Time frame: 3 days after consuming a fully controlled western style diet
Metabolic markers
Time frame: 3 days after consuming a fully controlled western style diet
Results and safety
The study was stopped early (reason given: Low recruitment rate; high proportion of screening failures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- 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.
Els van Hoffen, PhD principal investigator
NIZO food research BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by NIZO Food Research 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 7 inclusion and 29 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: stopped early, as of the sponsor's last update on 14 Jul 2017. 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. 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 was stopped early (reason given: Low recruitment rate; high proportion of screening failures.). Results are not available in the source record.
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?
Microbiota composition (time frame: 3 days after consuming a fully controlled western style diet). 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 14 Jul 2017.