Type 2 DiabetesNCT02694172
Human Faecal Microbiota in Type 2 Diabetes
A study testing Fiber rich cereal bars in people with Type 2 Diabetes and Healthy, run by Société des Produits Nestlé (SPN).
Trial summary
The main objective of the clinical trial is to investigate whether overweight type 2 diabetic patients have a different fecal microbiota profile compared with age, gender, BMI matched subjects and with lean healthy subjects before and after the consumption of fiber rich cereal bars. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Healthy, Overweight
- What is being tested?
- Fiber rich cereal bars
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Apr 2011
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -All diabetic and control non-diabetic subjects (of same BMI) must comply with all the following inclusion criteria:
- Ethnic background: Caucasian
- BMI: 25 to 40 kg/m2
- Fasting blood glucose > 7 mmol/L
- Fasting Hemoglobin A1c > 7%
- Consume mainly typical Western diets daily
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- Having obtained his/her informed consent
- Lean non-diabetic healthy subjects must comply with the following inclusion criteria:
- Ethnic background: Caucasian
- BMI: 20 to 25 kg/m2
- Fasting blood glucose < 5.5 mmol/L
- Fasting Hemoglobin A1c < 6 %
- Consume mainly typical Western diets daily
- Having obtained his/her informed consent
Who cannot join
- Diabetic and healthy (same BMI) subjects representing one or more of the following criteria are excluded from participation in the study.
- Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators
- People actively take cortisol or dexamethasone should be excluded from the study
- People under a-amylase/a-glucosidase inhibitors should be excluded from the study. However, patients under metformin can be accepted for this study.
- Patients under metformin suffering from gastrointestinal side effects within a 6-month time period prior to the trial
- Regular consumption of fermented dairy products
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- Vegetarians
- Frequent diarrhea (more than two loose stool per day) within 7 days before the enrollment
- HIV seropositive
- Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, peptic ulcers and cancer
- Patients who cannot be expected to comply with treatment
- Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
- Females with hormone therapy will be excluded from the study
- Lean healthy subjects representing one or more of the following criteria are excluded from participation in the study.
- Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators
- Regular consumption of fermented dairy products
- Vegetarians
- Frequent diarrhea (more than two loose stool per day) within 7 days before the enrollment
- HIV seropositive
- Having known gastrointestinal diseases such as ulcerative colitis, Crohn's disease, peptic ulcers and cancer
- Patients who cannot be expected to comply with treatment
- Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
- Females with hormone therapy will be excluded from the study
About this study
Official title: Analysis of the Diversity of Faecal Bacteria in Healthy and Type 2 Diabetic Subjects
The main objective of the clinical trial is to investigate whether overweight type 2 diabetic patients have a different fecal microbiota profile compared with age, gender, BMI matched subjects and with lean healthy subjects before and after the consumption of fiber rich cereal bars.
Read the detailed description
Gut microbiota refers to the bacterial communities in the gastrointestinal tract. The diversity and quantity of bacteria vary depending on age of the individuals, daily diet and the segment of the intestine, which makes the gut microbiota one of the most complex bacterial ecosystems known to men. In general, over trillions of bacteria reside in human gut. Recent evidence indicates that gut microbiota could be involved in host metabolism by multiple pathways leading to the development of obesity and type 2 diabetes. Increased fat storage or obesity has become one of the leading public health issues in many developed and developing countries. However, it is not clear whether type 2 diabetes is associated with a unique gut microbiota profile. Therefore, the primary objective of the study is to compare the fecal microbiota of overweight type 2 diabetic subjects to that of age, gender and BMI matched subjects as well as with lean non-diabetic subjects. In addition, the investigators hypothesize that microbiota modifications with consumption of fiber rich food products can improve the metabolic outcomes of type 2 diabetics. To test this hypothesis, the investigators plan to provide each overweight participant with two cereal bars per day for 4 weeks. Anthropometric measurements and plasma parameters as well as the fecal microbiota will be determined.
- Conditions
- Type 2 Diabetes, Healthy, Overweight
- Being tested
- Fiber rich cereal bars
- Keywords
- diabetes mellitus type 2, healthy subjects, human microbiome, cereal bar
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber rich cereal barsOther
Also called Nutren balance bars
Two cereals per day and per subject for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lean non diabetic | No intervention | Lean and healthy subjects receiving no intervention |
| Overweight non diabetic | Experimental | fiber rich cereal bars, two bars a day for 4 weeks Receives: Other: Fiber rich cereal bars |
| Overweight diabetic | Experimental | fiber rich cereal bars, two bars a day for 4 weeks Receives: Other: Fiber rich cereal bars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota profile
Fecal samples taken after the two week diet normalization are subjected to bacteria 16S rDNA sequencing and by quantitative PCR.
Measured: Baseline samples taken after 2 weeks of diet normalization period
Secondary outcomes (9)
Metabonomic analysis in faeces
Samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Measured: Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in plasma
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in urine
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects. Then, samples are analyzed by 1HNMR.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma glucose
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma insulin
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma free fatty acids
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma triglycerides
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma total cholesterol
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma HDL cholesterol
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects. Post intervention samples from overweight non-diabetic and diabetic subjects.
Measured: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Alain Golay, Prof, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694172
- Sponsor's protocol ID
- 06.42.NRC
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Diversity of Faecal Bacteria in Healthy and Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT02694172
- Acronym / sponsor ID
- 06.42.NRC
- Conditions
- Type 2 Diabetes, Healthy, Overweight
- Keywords
- diabetes mellitus type 2, healthy subjects, human microbiome, cereal bar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Imperial College London
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Feb 2016 (estimated)
- 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 main objective of the clinical trial is to investigate whether overweight type 2 diabetic patients have a different fecal microbiota profile compared with age, gender, BMI matched subjects and with lean healthy subjects before and after the consumption of fiber rich cereal bars.
Detailed description
Gut microbiota refers to the bacterial communities in the gastrointestinal tract. The diversity and quantity of bacteria vary depending on age of the individuals, daily diet and the segment of the intestine, which makes the gut microbiota one of the most complex bacterial ecosystems known to men. In general, over trillions of bacteria reside in human gut. Recent evidence indicates that gut microbiota could be involved in host metabolism by multiple pathways leading to the development of obesity and type 2 diabetes. Increased fat storage or obesity has become one of the leading public health issues in many developed and developing countries. However, it is not clear whether type 2 diabetes is associated with a unique gut microbiota profile. Therefore, the primary objective of the study is to compare the fecal microbiota of overweight type 2 diabetic subjects to that of age, gender and BMI matched subjects as well as with lean non-diabetic subjects. In addition, the investigators hypothesize that microbiota modifications with consumption of fiber rich food products can improve the metabolic outcomes of type 2 diabetics. To test this hypothesis, the investigators plan to provide each overweight participant with two cereal bars per day for 4 weeks. Anthropometric measurements and plasma parameters as well as the fecal microbiota will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean non diabetic | No intervention | –Lean and healthy subjects receiving no intervention |
| Overweight non diabetic | Experimental | Other: Fiber rich cereal barsfiber rich cereal bars, two bars a day for 4 weeks |
| Overweight diabetic | Experimental | Other: Fiber rich cereal barsfiber rich cereal bars, two bars a day for 4 weeks |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- -All diabetic and control non-diabetic subjects (of same BMI) must comply with all the following inclusion criteria:
- Ethnic background: Caucasian
- BMI: 25 to 40 kg/m2
- Fasting blood glucose > 7 mmol/L
- Fasting Hemoglobin A1c > 7%
Key exclusion criteria (23 listed)
- Diabetic and healthy (same BMI) subjects representing one or more of the following criteria are excluded from participation in the study.
- Dietary supplements or medications known to alter gut bacteria, such as antibiotic medication or intestinal transit modulators
- People actively take cortisol or dexamethasone should be excluded from the study
- People under a-amylase/a-glucosidase inhibitors should be excluded from the study. However, patients under metformin can be accepted for this study.
- Patients under metformin suffering from gastrointestinal side effects within a 6-month time period prior to the trial
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 |
|---|---|---|
| Fiber rich cereal barsAlso: Nutren balance barsTwo cereals per day and per subject for 4 weeks | Other | Overweight diabetic, Overweight non diabetic |
Primary outcome
Fecal microbiota profile
Time frame: Baseline samples taken after 2 weeks of diet normalization period
Fecal samples taken after the two week diet normalization are subjected to bacteria 16S rDNA sequencing and by quantitative PCR.
9 secondary outcomes
Metabonomic analysis in faeces
Time frame: Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in plasma
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Metabonomic analysis in urine
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma glucose
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma insulin
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma free fatty acids
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma triglycerides
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma total cholesterol
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
Plasma HDL cholesterol
Time frame: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
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 29 Feb 2016.
- 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.
Alain Golay, Prof principal investigator
University Hospital, Geneva
Questions about this trial
What is this clinical trial studying?
A study testing Fiber rich cereal bars in people with Type 2 Diabetes and Healthy, run by Société des Produits Nestlé (SPN).
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 14 inclusion and 23 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 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Fecal microbiota profile (time frame: Baseline samples taken after 2 weeks of diet normalization period). 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 29 Feb 2016.