Human Faecal Microbiota in Type 2 Diabetes
26. februar 2016 opdateret af: Société des Produits Nestlé (SPN)
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
67
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
-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
- 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
Exclusion Criteria:
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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Lean non diabetic
Lean and healthy subjects receiving no intervention
|
|
|
Eksperimentel: Overweight non diabetic
fiber rich cereal bars, two bars a day for 4 weeks
|
Two cereals per day and per subject for 4 weeks
Andre navne:
|
|
Eksperimentel: Overweight diabetic
fiber rich cereal bars, two bars a day for 4 weeks
|
Two cereals per day and per subject for 4 weeks
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fecal microbiota profile
Tidsramme: 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.
|
Baseline samples taken after 2 weeks of diet normalization period
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Metabonomic analysis in faeces
Tidsramme: Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
|
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.
|
Samples taken after 2 weeks of diet normalization period (baseline) and 4 weeks of cereal bars intake when applicable
|
|
Metabonomic analysis in plasma
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
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.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
|
Metabonomic analysis in urine
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
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.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
|
Plasma glucose
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects.
Post intervention samples from overweight non-diabetic and diabetic subjects.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
|
Plasma insulin
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects.
Post intervention samples from overweight non-diabetic and diabetic subjects.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
|
Plasma free fatty acids
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects.
Post intervention samples from overweight non-diabetic and diabetic subjects.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
|
Plasma triglycerides
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects.
Post intervention samples from overweight non-diabetic and diabetic subjects.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
|
Plasma total cholesterol
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects.
Post intervention samples from overweight non-diabetic and diabetic subjects.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
|
Plasma HDL cholesterol
Tidsramme: Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
Baseline samples for lean non-diabetic, overweight non-diabetic and overweight diabetic subjects.
Post intervention samples from overweight non-diabetic and diabetic subjects.
|
Samples taken after 2 weeks of diet normalization period and 4 weeks of cereal bars intake when applicable
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alain Golay, Prof, University Hospital, Geneva
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2007
Primær færdiggørelse (Faktiske)
1. juni 2009
Studieafslutning (Faktiske)
1. april 2011
Datoer for studieregistrering
Først indsendt
18. februar 2016
Først indsendt, der opfyldte QC-kriterier
26. februar 2016
Først opslået (Skøn)
29. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06.42.NRC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Fiber rich cereal bars
-
San Diego State UniversityRekruttering
-
Clinical Nutrition Research Center, Illinois Institute...AfsluttetSund og raskForenede Stater