ObesityNUTRIBIOTANCT04799223
Personalized Modulation of Microbiota
A study testing Four-foods eating guidelines and No designed-foods eating guidelines in people with Obesity and Microbial Colonization, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Intestinal flora or microbiota is the group of bacteria that live in the intestine, in a symbiotic relationship with the human body. It is estimated that human beings have around 2,000 different bacteria species. The gut microbiota plays a key in many of the body's functions. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Microbial Colonization, Nutrition Disorders
- What is being tested?
- Four-foods eating guidelines and No designed-foods eating guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2020to 15 May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers of both sexes with ages between 20 and 65 years.
- Volunteers with a body mass index between 24.9 and 34.9 kg / m2.
- Volunteers with intestinal dysbiosis.
- Physical examination and normal vital signs or clinically irrelevant for the study.
- Subjects must be able to understand and be willing to sign the informed consent.
Who cannot join
- Volunteers who have taken antibiotics or corticosteroids one month before the start of the intervention or antihistamines 15 days before the start of the intervention.
- Volunteers who are taken gastric protectors chronically.
- Volunteers who present changes in their pharmacological treatment in the last 3 months before the start of the study.
- Volunteers with intestinal pathologies (ulcerative colitis, Crohn's disease, or similar).
- Volunteers suffering from Covid-19
Trial locations and contacts
1 site in 1 country.
Spain1 site
Center for Nutrition Research. University of Navarra
Pamplona, Navarre
About this study
Official title: Personalized Modulation of the Microbiota Through the Intelligent Design of Foods and Ingredients Based on Enterotype-Based Diagnosis (NUTRIBIOTA). Nutritional Intervention in Humans
Intestinal flora or microbiota is the group of bacteria that live in the intestine, in a symbiotic relationship with the human body. It is estimated that human beings have around 2,000 different bacteria species. The gut microbiota plays a key in many of the body's functions. Hence, the analysis of the gut microbiome provides insight into the state of the microbiota as an indicator of overall health due to its metabolic, protective and nutritional functions. A balanced diet promotes the formation and maintenance of a well-structured microbiota, in which the different species of microorganisms cohabit in a balanced and controlled system.
The study is based on the hypothesis that the intake of certain plant-based foods rich in various active ingredients (especially non-digestible carbohydrates, certain types of fats and polyphenols) can modulate the microbiota and thus improve the health status of the human population.
Taking into account this background, the objective of this study is to assess the effect of the inclusion of functional foods and ingredients within a balanced diet on the composition of the microbiota and also on health parameters associated with metabolic disease.
Read the detailed description
The 60 volunteers participating in the study who meet the inclusion criteria, will be randomly divided into two groups:
- Control group (nutritional promotion): volunteers will be provided with basic nutritional recommendations based on a Mediterranean diet.
- Experimental group (Nutribiota): volunteers will be instructed to follow a dietary strategy similar to the control group, but including the functional foods and ingredients developed by the companies with the aim to promote a balanced and specific diet associated with improvements in the composition of the microbiota and metabolic parameters of the volunteers.
The duration of the study are 8 weeks, during which 4 visits are scheduled:
- Recruitment: this visit will consist on an initial screening in which the volunteers will be informed about the characteristics of the study and will be receive the information sheet and the informed consent form to be signed by all those interested in participating in the study. Volunteers who meet the inclusion for the study will be asked to complete the Food Frequency Questionnaire and Physical Activity Questionnaire for the next visit (visit 1). In addition, each participant will be provided with a faecal microbiota sample collection kit which they will have to hand in with the corresponding sample at the next visit (visit 1).
- Clinical investigation day 1 (week 0):after a fasting period of at least 10 hours, the nursing staff will take a blood sample to analyze the biochemical parameters and metabolomic profile. Anthropometric measurements will be taken from each volunteer (weight, height, waist and hip circumference, and body composition analysis by bioimpedance) with the collaboration of a dietician. In addition, faecal sample and Food Frequency Questionnaire and Physical Activity Questionnaire will be collected. Volunteers randomly assigned to the experimental group will be given the dishes and functional ingredients designed by the companies, which they will have to incorporate into a balanced dietary pattern following the indications given by the dietician.
- Clinical investigation day 2 (week 4): In this visit, the adherence of the volunteers to the study will be monitored and the weight of the volunteers will be registered. In addition, all study volunteers will be given a faecal microbiota sample collection kit, which should be handed in with the corresponding sample at the final visit. Moreover, Food Frequency Questionnaire and Physical Activity Questionnaire will be given to each volunteer in order to be filled for the final visit. Volunteers who belong to the experimental group will be given dishes and functional ingredients.
- Clinical investigation day 3 (week 8): Faecal sample, Food Frequency Questionnaire and Physical Activity Questionnaire will be collected. The procedures in this visit will be the same as in visit 1, but dishes and functional ingredients will not be given to the volunteers.
- Conditions
- Obesity, Microbial Colonization, Nutrition Disorders
- Being tested
- Four-foods eating guidelines, No designed-foods eating guidelines
- Keywords
- Obesity, Fecal microbiota, Nutrition, Diet, Insulin
- Medical subject headings
- Obesity, Communicable Diseases, Nutrition Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-foods eating guidelinesOther
To follow a healthy eating pattern and consume four (4) foods designed for the study (extra virgin olive oil with olive leaf extract, chickpea dish with spinach, vegetable cream dish, and olive fiber) and to follow a healthy eating pattern.
No designed-foods eating guidelinesOther
To follow a healthy eating pattern. Their diet is not accompanied by the four newly designed foods of the other group.
| Study group | Role | What they receive |
|---|---|---|
| Group receiving the 4 designed foods | Experimental | The experimental group consumes the 4 foods designed for the study and will follow healthy eating guidelines. Receives: Other: Four-foods eating guidelines |
| Group with no designed foods | Active comparator | The control group follows healthy eating guidelines. Receives: Other: No designed-foods eating guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of fecal microbiota composition
Measured by analyzing the variable regions V3-V4 of the prokaryotic 16S rRNA (ribosomal ribonucleic acid) gene sequences, which gives 460 bp amplicons in a two-round PCR protocol. The kit used will be the Nextera® XT DNA Index Kit, FC-131-1002 (Illumina, San Diego, CA, USA).
In the first step, PCR is used to amplify a template out of a DNA fecal sample using specific primers from Illumina. Then, sequencing libraries are built with the MiSeq® Reagent Kit v3 (600 cycles) MS-102-3003 (Illumina). Finally, paired-end sequencing is performed on a MiSeq platform (Illumina) with a 600 cycles Miseq run.
Fecal samples are self-collected by the volunteers' fecal samples using OMNIgene.GUT kits from DNA Genotek (Ottawa, ONT, Canada), according to the standard instructions provided by the company
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Secondary outcomes (16)
Change of glucose concentration
Glucose concentration will be reported in mg/dl
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of total cholesterol concentration
Total cholesterol concentration will be reported in mg/dl
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of LDL-cholesterol concentration
LDL-cholesterol concentration will be reported in mg/dl by Friedewald equation.
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of HDL-cholesterol concentration
HDL-cholesterol concentration will be reported in mg/dl
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of triglyceride concentration
Triglyceride concentration will be reported in mg/dl
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of aspartate aminotransaminase concentration
Aspartate aminotransaminase concentration will be reported in mg/dl
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of alanine aminotransferase concentration
Alanine aminotransferase concentration will be reported in U/L
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of insulin concentration
Insulin concentration will be reported in U/L
Measured: Clinical The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).day 1 and 3
Change of body weight
Body weight will be reported in kg
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body mass index
Body weight will be reported in kg
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body fat mass percentage
Body fat mass will be reported in percentage
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body lean mass
Body lean mass will be reported in kg
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body water percentage
Body water will be reported in percentage
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of visceral fat level
Visceral fat level will be reported
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of physical activity
Physical activity level will be monitored by physical activity questionnaire
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of dietary intake
Dietary energy and macronutrient intake will be monitored by a food frequency questionnaire
Measured: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Nov 2020
- Primary completion30 Mar 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fermín Milagro Yoldi, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Fermín Milagro Yoldi, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799223
- Sponsor's protocol ID
- NUTRIBIOTA
- Acronym
- NUTRIBIOTA
- Status last verified
- Feb 2023
- First submitted
- 4 Mar 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Modulation of the Microbiota Through the Intelligent Design of Foods and Ingredients Based on Enterotype-Based Diagnosis (NUTRIBIOTA). Nutritional Intervention in Humans
- ClinicalTrials.gov ID
- NCT04799223
- Acronym / sponsor ID
- NUTRIBIOTA / NUTRIBIOTA
- Conditions
- Obesity, Microbial Colonization, Nutrition Disorders
- Keywords
- Obesity, Fecal microbiota, Nutrition, Diet, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 16 Mar 2021 (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.
Intestinal flora or microbiota is the group of bacteria that live in the intestine, in a symbiotic relationship with the human body. It is estimated that human beings have around 2,000 different bacteria species. The gut microbiota plays a key in many of the body's functions. Hence, the analysis of the gut microbiome provides insight into the state of the microbiota as an indicator of overall health due to its metabolic, protective and nutritional functions. A balanced diet promotes the formation and maintenance of a well-structured microbiota, in which the different species of microorganisms cohabit in a balanced and controlled system.
The study is based on the hypothesis that the intake of certain plant-based foods rich in various active ingredients (especially non-digestible carbohydrates, certain types of fats and polyphenols) can modulate the microbiota and thus improve the health status of the human population.
Taking into account this background, the objective of this study is to assess the effect of the inclusion of functional foods and ingredients within a balanced diet on the composition of the microbiota and also on health parameters associated with metabolic disease.
Detailed description
The 60 volunteers participating in the study who meet the inclusion criteria, will be randomly divided into two groups:
- Control group (nutritional promotion): volunteers will be provided with basic nutritional recommendations based on a Mediterranean diet.
- Experimental group (Nutribiota): volunteers will be instructed to follow a dietary strategy similar to the control group, but including the functional foods and ingredients developed by the companies with the aim to promote a balanced and specific diet associated with improvements in the composition of the microbiota and metabolic parameters of the volunteers.
The duration of the study are 8 weeks, during which 4 visits are scheduled:
- Recruitment: this visit will consist on an initial screening in which the volunteers will be informed about the characteristics of the study and will be receive the information sheet and the informed consent form to be signed by all those interested in participating in the study. Volunteers who meet the inclusion for the study will be asked to complete the Food Frequency Questionnaire and Physical Activity Questionnaire for the next visit (visit 1). In addition, each participant will be provided with a faecal microbiota sample collection kit which they will have to hand in with the corresponding sample at the next visit (visit 1).
- Clinical investigation day 1 (week 0):after a fasting period of at least 10 hours, the nursing staff will take a blood sample to analyze the biochemical parameters and metabolomic profile. Anthropometric measurements will be taken from each volunteer (weight, height, waist and hip circumference, and body composition analysis by bioimpedance) with the collaboration of a dietician. In addition, faecal sample and Food Frequency Questionnaire and Physical Activity Questionnaire will be collected. Volunteers randomly assigned to the experimental group will be given the dishes and functional ingredients designed by the companies, which they will have to incorporate into a balanced dietary pattern following the indications given by the dietician.
- Clinical investigation day 2 (week 4): In this visit, the adherence of the volunteers to the study will be monitored and the weight of the volunteers will be registered. In addition, all study volunteers will be given a faecal microbiota sample collection kit, which should be handed in with the corresponding sample at the final visit. Moreover, Food Frequency Questionnaire and Physical Activity Questionnaire will be given to each volunteer in order to be filled for the final visit. Volunteers who belong to the experimental group will be given dishes and functional ingredients.
- Clinical investigation day 3 (week 8): Faecal sample, Food Frequency Questionnaire and Physical Activity Questionnaire will be collected. The procedures in this visit will be the same as in visit 1, but dishes and functional ingredients will not be given to the volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group receiving the 4 designed foods | Experimental | Other: Four-foods eating guidelinesThe experimental group consumes the 4 foods designed for the study and will follow healthy eating guidelines. |
| Group with no designed foods | Active comparator | Other: No designed-foods eating guidelinesThe control group follows healthy eating guidelines. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers of both sexes with ages between 20 and 65 years.
- Volunteers with a body mass index between 24.9 and 34.9 kg / m2.
- Volunteers with intestinal dysbiosis.
- Physical examination and normal vital signs or clinically irrelevant for the study.
- Subjects must be able to understand and be willing to sign the informed consent.
Key exclusion criteria (5 listed)
- Volunteers who have taken antibiotics or corticosteroids one month before the start of the intervention or antihistamines 15 days before the start of the intervention.
- Volunteers who are taken gastric protectors chronically.
- Volunteers who present changes in their pharmacological treatment in the last 3 months before the start of the study.
- Volunteers with intestinal pathologies (ulcerative colitis, Crohn's disease, or similar).
- Volunteers suffering from Covid-19
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 |
|---|---|---|
| Four-foods eating guidelinesTo follow a healthy eating pattern and consume four (4) foods designed for the study (extra virgin olive oil with olive leaf extract, chickpea dish with spinach, vegetable cream dish, and olive fiber) and to follow a healthy eating pattern. | Other | Group receiving the 4 designed foods |
| No designed-foods eating guidelinesTo follow a healthy eating pattern. Their diet is not accompanied by the four newly designed foods of the other group. | Other | Group with no designed foods |
Primary outcome
Change of fecal microbiota composition
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Measured by analyzing the variable regions V3-V4 of the prokaryotic 16S rRNA (ribosomal ribonucleic acid) gene sequences, which gives 460 bp amplicons in a two-round PCR protocol. The kit used will be the Nextera® XT DNA Index Kit, FC-131-1002 (Illumina, San Diego, CA, USA). In the first step, PCR is used to amplify a template out of a DNA fecal sample using specific primers from Illumina. Then, sequencing libraries are built with the MiSeq® Reagent Kit v3 (600 cycles) MS-102-3003 (Illumina). Finally, paired-end sequencing is performed on a MiSeq platform (Illumina) with a 600 cycles Miseq run. Fecal samples are self-collected by the volunteers' fecal samples using OMNIgene.GUT kits from DNA Genotek (Ottawa, ONT, Canada), according to the standard instructions provided by the company
16 secondary outcomes
Change of glucose concentration
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of total cholesterol concentration
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of LDL-cholesterol concentration
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of HDL-cholesterol concentration
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of triglyceride concentration
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of aspartate aminotransaminase concentration
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of alanine aminotransferase concentration
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of insulin concentration
Time frame: Clinical The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).day 1 and 3
Change of body weight
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body mass index
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body fat mass percentage
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body lean mass
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of body water percentage
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of visceral fat level
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of physical activity
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
Change of dietary intake
Time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).
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 3 Feb 2023.
- 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.
Fermín Milagro Yoldi, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-foods eating guidelines and No designed-foods eating guidelines in people with Obesity and Microbial Colonization, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 5 inclusion and 5 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 3 Feb 2023. 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 Spain. 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?
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 of fecal microbiota composition (time frame: The Time Frame contains two time points: day 1 (at baseline) compared to day 3 (after 8 weeks of dietary intervention).). 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 3 Feb 2023.