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

Instituto Potosino De Investigacion Cientifica Y Tecnologica AC

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: AmProt (amaranth protein isolate)

Study type: Interventional

Funder types: Other

Identifiers

NCT07583043

SLP/006-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

NW-AmProt

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: AmProt (amaranth protein isolate)

OB-AmProt

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: AmProt (amaranth protein isolate)

OW-AmProt

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: AmProt (amaranth protein isolate)