Effect of Diet Supplementation With Amaranth Protein on Mexican Children With Overweight and Obesity (AmProtObes)
Dietary Supplementation With Amaranth Protein Isolate Modu-lates the Gut Microbiota in Children With Overweight and Obe-sity: A Nonrandomized Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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San Luis Potosí
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Mexquitic de Carmona, San Luis Potosí, Mexique, 78480
- Dif Muncipal de Mexquitic de Carmona
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- children who had not received antibiotics, prebiotics, or other drugs
Exclusion Criteria:
- children with other diseases and those who refused to sign informed consent form
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: NW-AmProt
Group of children with normal weight according to their BMI that receive daily 2g of amaranth protein as diet supplementation
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Groups of children taken 2 g of amaranth protein isolate daily for 90 days
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Comparateur actif: OB-AmProt
Group of children with overweight according to their BMI that receive daily 2g of amaranth protein as diet supplementation
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Groups of children taken 2 g of amaranth protein isolate daily for 90 days
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Comparateur actif: OW-AmProt
Group of children with obesitty according to their BMI that receive daily 2g of amaranth protein as diet supplementation
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Groups of children taken 2 g of amaranth protein isolate daily for 90 days
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fecal DNA extraction and 16S rRNA gene sequencing sing the V4-V5 region of the 16S rRNA gene.
Délai: Samples were taken at the beginning and after 90 days
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Number of ASVs in each analyzed group, alfa and beta diversity, ASVs abundance
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Samples were taken at the beginning and after 90 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Measurements of fecal Short Chain Fatty Acids (SCFAs) levels
Délai: Samples were taken at the beginning and after 90 days
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Data of mg/g of acetic, propionic, butyric acids and total SCFAs
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Samples were taken at the beginning and after 90 days
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Hematological and biochemical serum analyses
Délai: 3 months
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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)
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3 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Monica L Rangel Martinez, MD, Servicios de Salud de San Luis Potosi
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SLP/006-2018
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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