Intestinal MicrobiotaTORNADONCT01449383
Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults
A study testing low meat high fibre and high meat low fibre in people with Intestinal Microbiota and Blood Markers, run by German Institute of Human Nutrition.
Trial summary
This study aims to investigate the direct effect of high amounts of dietary fibre and high amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Microbiota, Blood Markers
- What is being tested?
- low meat high fibre and high meat low fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Aug 2012
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20 to 60
- obtained informed consent
- willing and able to consume defined diets
- willing and able to collect all intended samples
Who cannot join
- prevalent chronic disease, i.e. diabetes (type 1 and 2), cardiovascular diseases, cancer
- Antibiotic treatment within the last three month before start of studies
- Prevalent gastrointestinal diseases, disorders and surgeries
- Pregnancy and breastfeeding
About this study
Official title: Molecular Targets Open for Regulation by the Gut Flora - New Avenues for Improved Diet to Optimize European Health (TORANDO): WP2 Individual Intervention Studies- Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults
This study aims to investigate the direct effect of high amounts of dietary fibre and high amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers in healthy adults.
Read the detailed description
Human gut microbiota composition and its bacterial pathways are involved in many metabolic processes, including digestion of actually indigestible food components and fat storage. Due to that it may contributes to the developement of obesity being one of the most important risk factors for many chronic diseases. Gut microbiota is under the influence of nutrition, consumption of pro- and prebiotics can promote the growth of certain bacterial strains. In a cross over dietary intervention this work will investigate the effect of defined diets on the intestinal microbiota in 20 healthy adults. The diets contain either high amounts (more than 40g/d) of dietary fibre and low red meat (less than 30g/d) or low amounts (less than 20g/d) of dietary fibre and high amounts of red meat (200g/d). Intervention periods last 3 weeks each interrupted by a 3 weeks wash out period. Examination of participants will happen at the beginning and at the end of both interventions and will contain anthropometry, blood sample, faecal sample, urine sample and saliva sample.
- Conditions
- Intestinal Microbiota, Blood Markers
- Being tested
- low meat high fibre, high meat low fibre
- Keywords
- cross over, dietary intervention, fibre, red meat, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low meat high fibreDietary supplement
less than 30g red meat and at least 40g dietary fibre per day
high meat low fibreDietary supplement
at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day
| Study group | Role | What they receive |
|---|---|---|
| low meat high fibre (lmhf) | Active comparator | consumption of less than 30g red meat per day and at least 40g dietary fibre per day Receives: Dietary Supplement: low meat high fibre |
| high meat low fibre (hmlf) | Active comparator | consumption of 200g red meat and not more than 20g dietary fibre per day Receives: Dietary Supplement: high meat low fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in gut microbiota composition
Measured: baseline, week 3, 6 and 9
Secondary outcomes (3)
change in anthropometry
Body height, body weight, circumferences of waist, hip, upper arm and leg, lower leg and the thickness of body folds at waist, back, upper arm and leg, lower leg and thorax depth and width
Measured: baseline, week 3, 6 and 9
change in blood markers
clinical blood count, including Hba1c, gamma-GT, cholesterol, HDL, LDL, Triglycerides, s-creatinin, CRP
Measured: baseline, week 3, 6 and 9
change in salivary microbial composition
Measured: baseline, week 3, 6 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal MicrobiotaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University, Quadram Institute Bioscience, VTT Technical Research Centre of Finland
- Responsible party
- Principal investigator, Jana Foerster, German Institute of Human Nutrition
- Investigators
- Jana Foerster, PhD student, Principal investigator, German Institute of Human Nutrition Potsdam-Rehbruecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449383
- Sponsor's protocol ID
- KBBE-2007-2-2-07_WP2.4
- Acronym
- TORNADO
- Status last verified
- Aug 2012
- First submitted
- 5 Oct 2011
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Foerster J, Maskarinec G, Reichardt N, Tett A, Narbad A, Blaut M, Boeing H. The influence of whole grain products and red meat on intestinal microbiota composition in normal weight adults: a randomized crossover intervention trial. PLoS One. 2014 Oct 9;9(10):e109606. doi: 10.1371/journal.pone.0109606. eCollection 2014.
PubMed 25299601
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Targets Open for Regulation by the Gut Flora - New Avenues for Improved Diet to Optimize European Health (TORANDO): WP2 Individual Intervention Studies- Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults
- ClinicalTrials.gov ID
- NCT01449383
- Acronym / sponsor ID
- TORNADO / KBBE-2007-2-2-07_WP2.4
- Conditions
- Intestinal Microbiota, Blood Markers
- Keywords
- cross over, dietary intervention, fibre, red meat, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Umeå University, Quadram Institute Bioscience, VTT Technical Research Centre of Finland
- Study start
- Nov 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Oct 2011 (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.
This study aims to investigate the direct effect of high amounts of dietary fibre and high amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers in healthy adults.
Detailed description
Human gut microbiota composition and its bacterial pathways are involved in many metabolic processes, including digestion of actually indigestible food components and fat storage. Due to that it may contributes to the developement of obesity being one of the most important risk factors for many chronic diseases. Gut microbiota is under the influence of nutrition, consumption of pro- and prebiotics can promote the growth of certain bacterial strains. In a cross over dietary intervention this work will investigate the effect of defined diets on the intestinal microbiota in 20 healthy adults. The diets contain either high amounts (more than 40g/d) of dietary fibre and low red meat (less than 30g/d) or low amounts (less than 20g/d) of dietary fibre and high amounts of red meat (200g/d). Intervention periods last 3 weeks each interrupted by a 3 weeks wash out period. Examination of participants will happen at the beginning and at the end of both interventions and will contain anthropometry, blood sample, faecal sample, urine sample and saliva sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low meat high fibre (lmhf) | Active comparator | Dietary Supplement: low meat high fibreconsumption of less than 30g red meat per day and at least 40g dietary fibre per day |
| high meat low fibre (hmlf) | Active comparator | Dietary Supplement: high meat low fibreconsumption of 200g red meat and not more than 20g dietary fibre per day |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 20 to 60
- obtained informed consent
- willing and able to consume defined diets
- willing and able to collect all intended samples
Key exclusion criteria (4 listed)
- prevalent chronic disease, i.e. diabetes (type 1 and 2), cardiovascular diseases, cancer
- Antibiotic treatment within the last three month before start of studies
- Prevalent gastrointestinal diseases, disorders and surgeries
- Pregnancy and breastfeeding
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 |
|---|---|---|
| low meat high fibreless than 30g red meat and at least 40g dietary fibre per day | Dietary supplement | low meat high fibre (lmhf) |
| high meat low fibreat least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day | Dietary supplement | high meat low fibre (hmlf) |
Primary outcome
change in gut microbiota composition
Time frame: baseline, week 3, 6 and 9
3 secondary outcomes
change in anthropometry
Time frame: baseline, week 3, 6 and 9
change in blood markers
Time frame: baseline, week 3, 6 and 9
change in salivary microbial composition
Time frame: baseline, week 3, 6 and 9
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 14 Aug 2012.
- Derived from this study: PubMed 25299601Foerster J, Maskarinec G, Reichardt N, Tett A, Narbad A, Blaut M, Boeing H. The influence of whole grain products and red meat on intestinal microbiota composition in normal weight adults: a randomized crossover intervention trial. PLoS One. 2014 Oct 9;9(10):e109606. doi: 10.1371/journal.pone.0109606. eCollection 2014.
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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.
Jana Foerster, PhD student principal investigator
German Institute of Human Nutrition Potsdam-Rehbruecke
Questions about this trial
What is this clinical trial studying?
A study testing low meat high fibre and high meat low fibre in people with Intestinal Microbiota and Blood Markers, run by German Institute of Human Nutrition.
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 4 inclusion and 4 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 14 Aug 2012. 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?
change in gut microbiota composition (time frame: baseline, week 3, 6 and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01449383, which also lists 1 linked publication.
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 Aug 2012.