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临床试验/NCT07583043
NCT07583043已完成不适用

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

Instituto Potosino De Investigacion Cientifica Y Tecnologica AC1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年3月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

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

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究者

发起方
Instituto Potosino De Investigacion Cientifica Y Tecnologica AC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Paulina Barba de la Rosa

Titular Professor

Instituto Potosino De Investigacion Cientifica Y Tecnologica AC

研究点 (1)

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