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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07583043
Acronym
AmProtObes
Enrollment
56
Registered
2026-05-13
Start date
2018-03-10
Completion date
2018-06-30
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

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

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTAmProt (amaranth protein isolate)

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

Sponsors

Instituto Potosino De Investigacion Cientifica Y Tecnologica AC
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

All parties involved, including participants and investigators, know which treatment is being administered

Intervention model description

A non-randomized pilot/trial implementation trial

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fecal DNA extraction and 16S rRNA gene sequencing sing the V4-V5 region of the 16S rRNA gene.Samples were taken at the beginning and after 90 daysNumber of ASVs in each analyzed group, alfa and beta diversity, ASVs abundance

Secondary

MeasureTime frameDescription
Measurements of fecal Short Chain Fatty Acids (SCFAs) levelsSamples were taken at the beginning and after 90 daysData of mg/g of acetic, propionic, butyric acids and total SCFAs
Hematological and biochemical serum analyses3 monthsTable 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)

Countries

Mexico

Contacts

STUDY_DIRECTORMonica L Rangel Martinez, MD

Servicios de Salud de San Luis Potosi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026