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| Name | Class |
|---|---|
| EPS COMFAMA | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | ||
| Experimental Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astrolab-bio | Medellín | Antioquia | 050022 | Colombia |
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.
Beginning 1 year after publication with no end date
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.
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| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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