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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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San Luis Potosí
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Mexquitic de Carmona, San Luis Potosí, Mexico, 78480
- Dif Muncipal de Mexquitic de Carmona
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Fecal DNA extraction and 16S rRNA gene sequencing sing the V4-V5 region of the 16S rRNA gene.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Measurements of fecal Short Chain Fatty Acids (SCFAs) levels
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Monica L Rangel Martinez, MD, Servicios de Salud de San Luis Potosi
Publicaties en nuttige links
Algemene publicaties
- 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.
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SLP/006-2018
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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