Effect of Diet Supplementation With Amaranth Protein on Mexican Children With Overweight and Obesity

NCT07583043 | Completed

• 1 other identifier: SLP/006-2018
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The state of San Luis Potosí 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.

Conditions

Overweight and Obesity

Keywords

protein; diet supplementation; children; insulin resistance; adiponectin/leptin; gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Measurements of fecal Short Chain Fatty Acids (SCFAs) levels

  Samples were taken at the beginning and after 90 days

• Hematological and biochemical serum analyses

  3 months

Study Arms (3)

NW-AmProt

ACTIVE COMPARATOR

Group of children with normal weight according to their BMI that receive daily 2g of amaranth protein as diet supplementation

Dietary Supplement: AmProt (amaranth protein isolate)

OB-AmProt

ACTIVE COMPARATOR

Group of children with overweight according to their BMI that receive daily 2g of amaranth protein as diet supplementation

Dietary Supplement: AmProt (amaranth protein isolate)

OW-AmProt

ACTIVE COMPARATOR

Group of children with obesitty according to their BMI that receive daily 2g of amaranth protein as diet supplementation

Dietary Supplement: AmProt (amaranth protein isolate)

Interventions

AmProt (amaranth protein isolate) DIETARY_SUPPLEMENT

Groups of children taken 2 g of amaranth protein isolate daily for 90 days

NW-AmProt; OB-AmProt; OW-AmProt

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children who had not received antibiotics, prebiotics, or other drugs

You may not qualify if:

• children with other diseases and those who refused to sign informed consent form

Sponsors & Collaborators

• Instituto Potosino De Investigacion Cientifica Y Tecnologica AC: lead

Study Sites (1)

Dif Muncipal de Mexquitic de Carmona

Mexquitic de Carmona, San Luis Potosí, 78480, Mexico

Location

Related Publications (4)

• 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.

  PMID: 34725762 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.

  PMID: 41625558 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.

  PMID: 30813240 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.

  PMID: 40871231 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Monica L Rangel Martinez, MD

  Servicios de Salud de San Luis Potosi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All parties involved, including participants and investigators, know which treatment is being administered
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor

Model Details: A non-randomized pilot/trial implementation trial

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 13, 2026
• Study Start: March 10, 2018
• Primary Completion: March 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 13, 2026

Record last verified: 2026-04

Locations

ME (1)