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Completed

NCT Number: NCT07492485

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

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Key information

Conditions

Obesity & Overweight Body Weight Gut Microbiome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Astrolab-bio

Medellín, Antioquia, 050022, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in glycated hemoglobin (HbA1c)

    Time frame: Baseline and up to 3 months

    Change in HbA1c levels measured in blood samples.

  2. Change in HDL cholesterol

    Time frame: Baseline and up to 12 weeks

    Change in high-density lipoprotein (HDL) cholesterol levels measured in blood samples.

  3. Change in LDL cholesterol

    Time frame: Baseline and 12 weeks

    Change in low-density lipoprotein (LDL) cholesterol levels measured in blood samples.

  4. Change in triglycerides

    Time frame: Baseline and 12 weeks

    Change in triglyceride levels measured in blood samples.

  5. Change in total cholesterol

    Time frame: Baseline and 12 weeks

    Change in total cholesterol levels measured in blood samples.

  6. Change in fasting glucose

    Time frame: Baseline and 12 weeks

    Change in fasting blood glucose levels measured in blood samples.

  7. Change in body weight

    Time frame: Baseline and 12 weeks

    Change in body weight measured in kilograms (kg).

  8. Change in body mass index (BMI)

    Time frame: Baseline and 12 weeks

    Change in body mass index (BMI), calculated as weight (kg) divided by height squared (m²)

  9. Dietary adherence to intervention

    Time frame: Baseline, 6 weeks, and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Astrolab bio

Industry

Collaborators

  • EPS COMFAMA

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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