Gut, Microbiome, Obesity & Overweight
Conditions
Keywords
Gut health, Gut microbiome
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
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.
Interventions
OTHERPersonalized 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.
Sponsors
Astrolab bio
EPS COMFAMA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
23 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gut microbiota diversity (Shannon Index) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated hemoglobin (HbA1c) | Baseline and up to 3 months | Change in HbA1c levels measured in blood samples. |
| Change in HDL cholesterol | Baseline and up to 12 weeks | Change in high-density lipoprotein (HDL) cholesterol levels measured in blood samples. |
| Change in LDL cholesterol | Baseline and 12 weeks | Change in low-density lipoprotein (LDL) cholesterol levels measured in blood samples. |
| Change in triglycerides | Baseline and 12 weeks | Change in triglyceride levels measured in blood samples. |
| Change in total cholesterol | Baseline and 12 weeks | Change in total cholesterol levels measured in blood samples. |
| Change in fasting glucose | Baseline and 12 weeks | Change in fasting blood glucose levels measured in blood samples. |
| Change in body weight | Baseline and 12 weeks | Change in body weight measured in kilograms (kg). |
| Change in body mass index (BMI) | Baseline and 12 weeks | Change in body mass index (BMI), calculated as weight (kg) divided by height squared (m²) |
| Dietary adherence to intervention | 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. |
Countries
Colombia
Outcome results
None listed