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The state of San Luis Potosà comprises several municipalities with diverse environmental conditions, ranging from semi-tropical to very arid zones. Arid zones have a high rate of childhood with obesity. This study aimed to investigate the effects of dietary supplementation with high-quality protein on the modulation of the gut microbiota.
Overweight and obesity are chronic diseases that result from complex interactions including genetics, environment, eating behaviors, and limited access to a healthy diet. Amaranth grains contain high-quality proteins (well balance of essential amino acids), with good biodigestibiliy. In addition, amaranth proteins contains encrypted peptides with several biological functions with health benefits, such as antihypertensive, antidiabetic, antioxidant, and antiobosegenic, but those activities have been reported in vitro assays and in vivo using mice models. In mice, have been reported the amaranth proteins were able to decrease the serum cholesterol and triglycerides levels and can modulate the gut microbiota. But until now, there are no studies evaluating the amaranth proteins in children with overweight and obesity and the modulation of gut microbiota.
The work aimed to form a group of children aged 8-10 years with different Body Mass Index (BMI) which were allocated in groups as: normal weight (NW), overweight (OW), and with obesity (OB). Children received amaranth protein for 90 days, blood and feces were taken at the beginning and the end of the trial. Levels of fasting blood glucose, cholesterol, triglycerides, and insulin were analyzed. HOMA-IR and Adinopectin/Leptin ratio were calculated. Feces were used to analyze the metagenome and quantify the levels of Short Chain Fatty Acids (SCFAs).
The study was aproved by the Research Ethics Committe of the Health Services San Luis Potosi (No. SLP/006-2018) and conducted in accordance with the Helsinki Declaration (2000). Informed assent was obtained from the participating children, and the informed consent from their parents or legal representatives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NW-AmProt | Active Comparator | Group of children with normal weight according to their BMI that receive daily 2g of amaranth protein as diet supplementation |
|
| OB-AmProt | Active Comparator | Group of children with overweight according to their BMI that receive daily 2g of amaranth protein as diet supplementation |
|
| OW-AmProt | Active Comparator | Group of children with obesitty according to their BMI that receive daily 2g of amaranth protein as diet supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AmProt (amaranth protein isolate) | Dietary Supplement | Groups of children taken 2 g of amaranth protein isolate daily for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal DNA extraction and 16S rRNA gene sequencing sing the V4-V5 region of the 16S rRNA gene. | Number of ASVs in each analyzed group, alfa and beta diversity, ASVs abundance | Samples were taken at the beginning and after 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of fecal Short Chain Fatty Acids (SCFAs) levels | Data of mg/g of acetic, propionic, butyric acids and total SCFAs | Samples were taken at the beginning and after 90 days |
| Hematological and biochemical serum analyses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica L Rangel Martinez, MD | Servicios de Salud de San Luis Potosi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dif Muncipal de Mexquitic de Carmona | Mexquitic de Carmona | San Luis Potosà | 78480 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34725762 | Result | Aceves-Martins M, Lopez-Cruz L, Garcia-Botello M, Gutierrez-Gomez YY, Moreno-Garcia CF. Interventions to Prevent Obesity in Mexican Children and Adolescents: Systematic Review. Prev Sci. 2022 May;23(4):563-586. doi: 10.1007/s11121-021-01316-6. Epub 2021 Nov 2. | |
| 41625558 | Result | Liu K, Liu S, Wang D, Qiao H. Obesity-induced cognitive impairment: Underlying mechanisms and therapeutic prospects. Metabol Open. 2026 Jan 16;29:100444. doi: 10.1016/j.metop.2026.100444. eCollection 2026 Mar. |
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Hematological and biochemical data 16S rRNA gene sequecing raw data
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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A non-randomized pilot/trial implementation trial
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All parties involved, including participants and investigators, know which treatment is being administered
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Table of glucose, cholesterol triglycerides, and cholesterol (mg/dL). ALT, ALP, GGT enzymes activities (U/L). Insulin, leptin (ng/mL). TNF-a, IL-1B, IL-6 (pg/mL)
| 3 months |
| 30813240 | Result | Fruhbeck G, Catalan V, Rodriguez A, Ramirez B, Becerril S, Salvador J, Colina I, Gomez-Ambrosi J. Adiponectin-leptin Ratio is a Functional Biomarker of Adipose Tissue Inflammation. Nutrients. 2019 Feb 22;11(2):454. doi: 10.3390/nu11020454. |
| 40871231 | Result | Samudio-Cruz MA, Luna-Angulo A, Cabrera-Ruiz E, Landa-Solis C, Rangel-Lopez E, Carrillo-Mora P, Rios-Martinez J, Toledo-Perez R, Paniagua-Perez R, Martinez-Canseco CJ, Lino-Gonzalez AL, Saldana Solano AJ, Sanchez-Chapul L. The Bacterial Composition of the Gut Microbiota of Mexicans with Overweight and Obesity: A Systematic Review. Microorganisms. 2025 Jul 24;13(8):1727. doi: 10.3390/microorganisms13081727. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |