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

NCT07492485 | Completed

• 1 other identifier: 03-89-1109- 2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. Outcomes included gut microbiome composition, blood biomarkers, weight, physical activity frequency, and dietary adherence over 12 weeks

Conditions

Obesity & Overweight; Gut; Microbiome

Keywords

Gut health; Gut microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in glycated hemoglobin (HbA1c)

  Baseline and up to 3 months

• Change in HDL cholesterol

  Baseline and up to 12 weeks

• Change in LDL cholesterol

  Baseline and 12 weeks

• Change in triglycerides

  Baseline and 12 weeks

• Change in total cholesterol

  Baseline and 12 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Experimental Group

EXPERIMENTAL

Other: Personalized dietary recommendations

Interventions

Personalized dietary recommendations OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astrolab bio: lead
• EPS COMFAMA: collaborator

Study Sites (1)

Astrolab-bio

Medellín, Antioquia, 050022, Colombia

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 25, 2026
• Study Start: July 10, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: March 25, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 1 year after publication with no end date
• 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.

Locations

CO (1)