Obesity & OverweightNCT07492485
Precision Nutrition Recommendations Generated by Metataxonomic Microbiome Testing Improve Food Group Choices and Intestinal Health Indicators in an Obese Population in Colombia
A study testing Personalized dietary recommendations in people with Obesity & Overweight and Gut, run by Astrolab bio at 1 site in Colombia.
Trial summary
This study evaluated whether personalized dietary recommendations based on gut microbiome testing can improve intestinal health and food choices in adults with obesity in the region of Antioquia, Colombia. Fifty participants were randomly assigned to an intervention or control group. Read more about this study
- Who is it for?
- Ages 23 to 65 years
- Conditions the study is for
- Obesity & Overweight, Gut, Microbiome
- What is being tested?
- Personalized dietary recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 10 Jul 2023to 20 Feb 2024
- 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 23 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Affiliation with Comfama healthcare provider
- Age between 23 and 65 years
- Body Mass Index (BMI) ≥ 30 kg/m²
- Residence in Medellín, Antioquia, Colombia
- Willingness and ability to participate in the study for 12 weeks
Who cannot join
- Pregnancy or lactation
- History of bariatric surgery
- Diagnosed mental health conditions
- Use of specific medications (e.g., antidepressants, antibiotics)
- Participation in a structured nutritional plan
- Planned extended travel within the next 9 months
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluated whether personalized dietary recommendations based on gut microbiome testing can improve intestinal health and food choices in adults with obesity in the region of Antioquia, Colombia. Fifty participants were randomly assigned to an intervention or control group. Outcomes included gut microbiome composition, blood biomarkers, weight, physical activity frequency, and dietary adherence over 12 weeks
Read the detailed description
The study investigated the effects of precision nutrition recommendations on gut microbiota diversity and metabolic health in obese adults. Fifty participants (BMI ≥30) affiliated with Comfama healthcare in Antioquia, Colombia, were randomized into an intervention group (n=25) receiving a 12-week diet plan designed to improve microbial diversity and metabolic health, and a control group (n=25).
The intervention emphasized increased fiber intake, fermented foods, reduced sugar and saturated fats, and a variety of colorful fruits and vegetables. Probiotic or prebiotic supplements were included in selected cases. Outcomes were measured at baseline and after 12 weeks and included gut microbiota diversity via 16S rRNA gene sequencing (V3-V4 region), blood biomarkers (HbA1c, total cholesterol, HDL, LDL, triglycerides, glucose), anthropometric data, dietary adherence, physical activity, and psychological measures. Significant improvements in microbial diversity and intestinal health indicators were observed in the intervention group.
- Conditions
- Obesity & Overweight, Gut, Microbiome
- Being tested
- Personalized dietary recommendations
- Keywords
- Gut health, Gut microbiome
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized dietary recommendationsOther
Experimental: Personalized dietary intervention (n=25) Participants receive personalized dietary recommendations intended to improve gut microbiota diversity and metabolic health. Recommendations include increased dietary fiber intake, incorporation of fermented foods, reduced intake of added sugars and saturated fats, and increased consumption and variety of fruits and vegetables. Optional probiotic or prebiotic supplementation may be recommended.
Adherence is monitored through periodic online questionnaires and regular phone or text message follow-ups. Precise nutrient intake and supplement dosages are not strictly quantified.
Behavioral: Personalized dietary recommendations Individualized dietary guidance designed to promote gut microbiota diversity and metabolic health through increased fiber intake, fermented foods, reduced added sugars and saturated fats, and greater variety of fruits and vegetables. Optional probiotic or prebiotic supplementation may be included.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Experimental Group | Experimental | Not described Receives: Other: Personalized dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiota diversity (Shannon Index)
Change in gut microbiota diversity assessed using the Shannon Diversity Index via 16S rRNA sequencing (V3-V4 region).
Measured: Baseline and up to 3 months
Secondary outcomes (9)
Change in glycated hemoglobin (HbA1c)
Change in HbA1c levels measured in blood samples.
Measured: Baseline and up to 3 months
Change in HDL cholesterol
Change in high-density lipoprotein (HDL) cholesterol levels measured in blood samples.
Measured: Baseline and up to 12 weeks
Change in LDL cholesterol
Change in low-density lipoprotein (LDL) cholesterol levels measured in blood samples.
Measured: Baseline and 12 weeks
Change in triglycerides
Change in triglyceride levels measured in blood samples.
Measured: Baseline and 12 weeks
Change in total cholesterol
Change in total cholesterol levels measured in blood samples.
Measured: Baseline and 12 weeks
Change in fasting glucose
Change in fasting blood glucose levels measured in blood samples.
Measured: Baseline and 12 weeks
Change in body weight
Change in body weight measured in kilograms (kg).
Measured: Baseline and 12 weeks
Change in body mass index (BMI)
Change in body mass index (BMI), calculated as weight (kg) divided by height squared (m²)
Measured: Baseline and 12 weeks
Dietary adherence to intervention
Dietary adherence assessed using 3-day dietary records analyzed for compliance with the prescribed dietary intervention. Results will be expressed as percentage adherence to dietary recommendations.
Measured: Baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start10 Jul 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astrolab bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EPS COMFAMA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492485
- Sponsor's protocol ID
- 03-89-1109- 2012
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will only share this information by demand of the journal were the study will be published or with other researchers from recognized institutions (according to their ORCID profile) that direclty ask for the data. All data will be anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Nutrition Recommendations Generated by Metataxonomic Microbiome Testing Improve Food Group Choices and Intestinal Health Indicators in an Obese Population in Colombia
- ClinicalTrials.gov ID
- NCT07492485
- Acronym / sponsor ID
- 03-89-1109- 2012
- Conditions
- Obesity & Overweight, Gut, Microbiome
- Keywords
- Gut health, Gut microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Astrolab bioIndustry (pharma, biotech, devices)
- Collaborators
- EPS COMFAMA
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 25 Mar 2026 (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.
This study evaluated whether personalized dietary recommendations based on gut microbiome testing can improve intestinal health and food choices in adults with obesity in the region of Antioquia, Colombia. Fifty participants were randomly assigned to an intervention or control group. Outcomes included gut microbiome composition, blood biomarkers, weight, physical activity frequency, and dietary adherence over 12 weeks
Detailed description
The study investigated the effects of precision nutrition recommendations on gut microbiota diversity and metabolic health in obese adults. Fifty participants (BMI ≥30) affiliated with Comfama healthcare in Antioquia, Colombia, were randomized into an intervention group (n=25) receiving a 12-week diet plan designed to improve microbial diversity and metabolic health, and a control group (n=25).
The intervention emphasized increased fiber intake, fermented foods, reduced sugar and saturated fats, and a variety of colorful fruits and vegetables. Probiotic or prebiotic supplements were included in selected cases. Outcomes were measured at baseline and after 12 weeks and included gut microbiota diversity via 16S rRNA gene sequencing (V3-V4 region), blood biomarkers (HbA1c, total cholesterol, HDL, LDL, triglycerides, glucose), anthropometric data, dietary adherence, physical activity, and psychological measures. Significant improvements in microbial diversity and intestinal health indicators were observed in the intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Experimental Group | Experimental | Other: Personalized dietary recommendations |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Affiliation with Comfama healthcare provider
- Age between 23 and 65 years
- Body Mass Index (BMI) ≥ 30 kg/m²
- Residence in Medellín, Antioquia, Colombia
- Willingness and ability to participate in the study for 12 weeks
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- History of bariatric surgery
- Diagnosed mental health conditions
- Use of specific medications (e.g., antidepressants, antibiotics)
- Participation in a structured nutritional plan
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 |
|---|---|---|
| Personalized dietary recommendationsExperimental: Personalized dietary intervention (n=25) Participants receive personalized dietary recommendations intended to improve gut microbiota diversity and metabolic health. Recommendations include increased dietary fiber intake, incorporation of fermented foods, reduced intake of added sugars and saturated fats, and increased consumption and variety of fruits and vegetables. Optional probiotic or prebiotic supplementation may be recommended. Adherence is monitored through periodic online questionnaires and regular phone or text message follow-ups. Precise nutrient intake and supplement dosages are not strictly quantified. Behavioral: Personalized dietary recommendations Individualized dietary guidance designed to promote gut microbiota diversity and metabolic health through increased fiber intake, fermented foods, reduced added sugars and saturated fats, and greater variety of fruits and vegetables. Optional probiotic or prebiotic supplementation may be included. | Other | Experimental Group |
Primary outcome
Change in gut microbiota diversity (Shannon Index)
Time frame: Baseline and up to 3 months
Change in gut microbiota diversity assessed using the Shannon Diversity Index via 16S rRNA sequencing (V3-V4 region).
9 secondary outcomes
Change in glycated hemoglobin (HbA1c)
Time frame: Baseline and up to 3 months
Change in HDL cholesterol
Time frame: Baseline and up to 12 weeks
Change in LDL cholesterol
Time frame: Baseline and 12 weeks
Change in triglycerides
Time frame: Baseline and 12 weeks
Change in total cholesterol
Time frame: Baseline and 12 weeks
Change in fasting glucose
Time frame: Baseline and 12 weeks
Change in body weight
Time frame: Baseline and 12 weeks
Change in body mass index (BMI)
Time frame: Baseline and 12 weeks
Dietary adherence to intervention
Time frame: Baseline, 6 weeks, and 12 weeks
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 25 Mar 2026.
- Individual participant dataSharing planned: Yes. We will only share this information by demand of the journal were the study will be published or with other researchers from recognized institutions (according to their ORCID profile) that direclty ask for the data. All data will be anonymous.
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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 Personalized dietary recommendations in people with Obesity & Overweight and Gut, run by Astrolab bio at 1 site in Colombia.
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 6 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 25 Mar 2026. 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 Colombia. 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 in gut microbiota diversity (Shannon Index) (time frame: Baseline and up to 3 months). 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 25 Mar 2026.