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OpenTrials
Completed

NCT Number: NCT07583043

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

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.

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dif Muncipal de Mexquitic de Carmona

Mexquitic de Carmona, San Luis Potosí, 78480, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AmProt (amaranth protein isolate)

Dietary Supplement

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

Primary outcomes

  1. Fecal DNA extraction and 16S rRNA gene sequencing sing the V4-V5 region of the 16S rRNA gene.

    Time frame: Samples were taken at the beginning and after 90 days

    Number of ASVs in each analyzed group, alfa and beta diversity, ASVs abundance

Secondary outcomes

  1. Measurements of fecal Short Chain Fatty Acids (SCFAs) levels

    Time frame: Samples were taken at the beginning and after 90 days

    Data of mg/g of acetic, propionic, butyric acids and total SCFAs

  2. Hematological and biochemical serum analyses

    Time frame: 3 months

    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)

Sponsors and collaborators

Lead sponsor

Instituto Potosino De Investigacion Cientifica Y Tecnologica AC

Other

Registry information

Official study title

Dietary Supplementation With Amaranth Protein Isolate Modu-lates the Gut Microbiota in Children With Overweight and Obe-sity: A Nonrandomized Trial

Acronym: AmProtObes

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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