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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Aktiv komparator: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fecal DNA extraction and 16S rRNA gene sequencing sing the V4-V5 region of the 16S rRNA gene.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Measurements of fecal Short Chain Fatty Acids (SCFAs) levels
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Monica L Rangel Martinez, MD, Servicios de Salud de San Luis Potosi
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SLP/006-2018
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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