Nutrition DisordersNCT03475368
Interactions Between Diet, Intestinal Microbiota and Metabolomics
A study testing Vegetarian diet, Low carbs diet and Mediterranean diet in people with Nutrition Disorders, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
It is widely known that the quality of the diet is able to modify the expression of many bacterial genes populating the intestine of the host, as well as the type of bacteria themselves. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Vegetarian diet, Low carbs diet and Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 1 Apr 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No major comorbidities with a life expectancy less than 12 months;
- BMI between 29 and 33 kg/m2
- Serum cholesterol 200-260 mg/dl
- Serum triglycerides > 150 mg/dl
Who cannot join
- Antibiotics or prebiotics in the 3 months before the enrollment;
- Use of statins or other medications for lowering cholesterol;
- Menopause;
- Previous history of cancer.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte, BARI, 70013
About this study
Official title: Diet, Intestinal Microbiota and Metabolomics: Evaluation of Possible Synergies
It is widely known that the quality of the diet is able to modify the expression of many bacterial genes populating the intestine of the host, as well as the type of bacteria themselves. This is also expressed with a more or less evident and troublesome after meals symptomatology that many patients complain to the health care staff.
A good composition of the microbiota is crucial for the health of the individual, both at the intestinal level as well as at the systemic level because, depending on the type of food substrate available at the intestinal level, metabolites will be produced capable of positively or negatively affect the health of the individual.
Read more
In fact, scientific evidence shows the existence of the causal link between the health of the microbiota and the genesis of inflammatory diseases not only intestinal, but also systemic, and even of cancer, obesity, metabolic syndrome and atherosclerosis.
The recent diffusion of gene sequencing techniques has brought significant developments in the study of the human and bacterial genome, which allow to produce enormous quantities of sequences at a lower cost and at a higher speed than previous techniques.
Therefore the clinical Nutrition Clinic of the IRCCS De Bellis in Castellana Grotte (BA) proposes to check if changes in the intestinal microbiota correlate, not only with anthropometric and clinical-laboratory parameters, but also with the typical symptoms of irritable bowel syndrome (IBS), a functional pathology very widespread with the advent of the modern era, in which, a diet rich in sugars and proteins of animal origin and poor in plant foods, is unfortunately common also in the areas of the Mediterranean basin.
- Conditions
- Nutrition Disorders
- Being tested
- Vegetarian diet, Low carbs diet, Mediterranean diet
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetarian dietOther
People randomized to this interventional group will take a vegetarian diet (i.e. without animal products, except milk and eggs).
Low carbs dietOther
People randomized to this interventional group will take low carbs diet (i.e. with a limited amount of carbohydrates)
Mediterranean dietOther
People randomized to this interventional group will take a traditional Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian diet | Experimental | People randomized to interventional groups will take a vegetarian diet (i.e. without animal products, except milk and eggs) Receives: Other: Vegetarian diet |
| Low carbs | Experimental | People randomized to interventional groups will take a low carbs diet (i.e. with a limited amount of carbohydrates). Receives: Other: Low carbs diet |
| Mediterranean diet | Active comparator | People randomized to interventional groups will take a mediterranean diet (i.e. with low glycemic index carbohydrates and vegetables). Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in weight
Measured: At baseline and after two months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gioacchino Leandro, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475368
- Sponsor's protocol ID
- 36
- Status last verified
- Apr 2018
- First submitted
- 16 Mar 2018
- Last updated
- 1 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zimmer J, Lange B, Frick JS, Sauer H, Zimmermann K, Schwiertz A, Rusch K, Klosterhalfen S, Enck P. A vegan or vegetarian diet substantially alters the human colonic faecal microbiota. Eur J Clin Nutr. 2012 Jan;66(1):53-60. doi: 10.1038/ejcn.2011.141. Epub 2011 Aug 3.
PubMed 21811294Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.
PubMed 17943116
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Intestinal Microbiota and Metabolomics: Evaluation of Possible Synergies
- ClinicalTrials.gov ID
- NCT03475368
- Acronym / sponsor ID
- 36
- Conditions
- Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 23 Mar 2018 (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.
It is widely known that the quality of the diet is able to modify the expression of many bacterial genes populating the intestine of the host, as well as the type of bacteria themselves. This is also expressed with a more or less evident and troublesome after meals symptomatology that many patients complain to the health care staff.
A good composition of the microbiota is crucial for the health of the individual, both at the intestinal level as well as at the systemic level because, depending on the type of food substrate available at the intestinal level, metabolites will be produced capable of positively or negatively affect the health of the individual.
In fact, scientific evidence shows the existence of the causal link between the health of the microbiota and the genesis of inflammatory diseases not only intestinal, but also systemic, and even of cancer, obesity, metabolic syndrome and atherosclerosis.
The recent diffusion of gene sequencing techniques has brought significant developments in the study of the human and bacterial genome, which allow to produce enormous quantities of sequences at a lower cost and at a higher speed than previous techniques.
Therefore the clinical Nutrition Clinic of the IRCCS De Bellis in Castellana Grotte (BA) proposes to check if changes in the intestinal microbiota correlate, not only with anthropometric and clinical-laboratory parameters, but also with the typical symptoms of irritable bowel syndrome (IBS), a functional pathology very widespread with the advent of the modern era, in which, a diet rich in sugars and proteins of animal origin and poor in plant foods, is unfortunately common also in the areas of the Mediterranean basin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegetarian diet | Experimental | Other: Vegetarian dietPeople randomized to interventional groups will take a vegetarian diet (i.e. without animal products, except milk and eggs) |
| Low carbs | Experimental | Other: Low carbs dietPeople randomized to interventional groups will take a low carbs diet (i.e. with a limited amount of carbohydrates). |
| Mediterranean diet | Active comparator | Other: Mediterranean dietPeople randomized to interventional groups will take a mediterranean diet (i.e. with low glycemic index carbohydrates and vegetables). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No major comorbidities with a life expectancy less than 12 months;
- BMI between 29 and 33 kg/m2
- Serum cholesterol 200-260 mg/dl
- Serum triglycerides > 150 mg/dl
Key exclusion criteria (4 listed)
- Antibiotics or prebiotics in the 3 months before the enrollment;
- Use of statins or other medications for lowering cholesterol;
- Menopause;
- Previous history of cancer.
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 |
|---|---|---|
| Vegetarian dietPeople randomized to this interventional group will take a vegetarian diet (i.e. without animal products, except milk and eggs). | Other | Vegetarian diet |
| Low carbs dietPeople randomized to this interventional group will take low carbs diet (i.e. with a limited amount of carbohydrates) | Other | Low carbs |
| Mediterranean dietPeople randomized to this interventional group will take a traditional Mediterranean diet. | Other | Mediterranean diet |
Primary outcome
Changes in weight
Time frame: At baseline and after two months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Background: PubMed 21811294Zimmer J, Lange B, Frick JS, Sauer H, Zimmermann K, Schwiertz A, Rusch K, Klosterhalfen S, Enck P. A vegan or vegetarian diet substantially alters the human colonic faecal microbiota. Eur J Clin Nutr. 2012 Jan;66(1):53-60. doi: 10.1038/ejcn.2011.141. Epub 2011 Aug 3.
- Background: PubMed 17943116Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetarian diet, Low carbs diet and Mediterranean diet in people with Nutrition Disorders, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 1 May 2018. 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 Italy. 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?
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?
Changes in weight (time frame: At baseline and after two months.). 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 NCT03475368, which also lists 2 linked publications.
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 1 May 2018.