Comparison of the Microbial Composition in Lean and Obese Subjects (DUPLO)

July 11, 2017 updated by: NIZO Food Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Ede, Netherlands, 6710 BA
        • NIZO food research BV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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;
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: IntelliCap
Sampling of the small intestine using a samling capsule.
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
Device: IntelliCap
Sampling of the small intestine using a samling capsule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 days after consuming a fully controlled western style diet

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total bacterial count
Time Frame: 3 days after consuming a fully controlled western style diet
Total bacterial count measured by qPCR in the small intestinal samples in lean vs obese subjects
3 days after consuming a fully controlled western style diet
Cytokine levels
Time Frame: 3 days after consuming a fully controlled western style diet
Cytokines levels in blood in relation to microbiota composition in lean vs obese subjects
3 days after consuming a fully controlled western style diet
Metabolic markers
Time Frame: 3 days after consuming a fully controlled western style diet
Glucose, insulin and cholesterol levels in blood in relation to microbiota composition in lean vs obese subjects
3 days after consuming a fully controlled western style diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NIZO Food Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danisco Sweeteners Oy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Els van Hoffen, PhD, NIZO food research BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 4, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL 59327.081.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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