Precision Nutrition Recommendations Generated by Metataxonomic Microbiome Testing Improve Food Group Choices and Intestinal Health Indicators in an Obese Population in Colombia

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

Study Overview

• Status: Completed
• Conditions: Microbiome; Obesity & Overweight; Gut
• Intervention / Treatment: Other: Personalized dietary recommendations

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050022
      • Astrolab-bio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Other: Personalized dietary recommendations; 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.
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycated hemoglobin (HbA1c)	Change in HbA1c levels measured in blood samples.	Baseline and up to 3 months
Change in HDL cholesterol	Change in high-density lipoprotein (HDL) cholesterol levels measured in blood samples.	Baseline and up to 12 weeks
Change in LDL cholesterol	Change in low-density lipoprotein (LDL) cholesterol levels measured in blood samples.	Baseline and 12 weeks
Change in triglycerides	Change in triglyceride levels measured in blood samples.	Baseline and 12 weeks
Change in total cholesterol	Change in total cholesterol levels measured in blood samples.	Baseline and 12 weeks
Change in fasting glucose	Change in fasting blood glucose levels measured in blood samples.	Baseline and 12 weeks
Change in body weight	Change in body weight measured in kilograms (kg).	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)	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.	Baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

• Sponsor: Astrolab bio
• Collaborators: EPS COMFAMA

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Gut microbiome; Gut health
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 03-89-1109- 2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 1 year after publication with no end date
• IPD Sharing Access Criteria: The data will only be shared by demand with other researchers that belong to recognized institutions according to the ORCID affiliation. All data sharing will be anonymous.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No