- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07583043
Effect of Diet Supplementation With Amaranth Protein on Mexican Children With Overweight and Obesity (AmProtObes)
Dietary Supplementation With Amaranth Protein Isolate Modu-lates the Gut Microbiota in Children With Overweight and Obe-sity: A Nonrandomized Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
San Luis Potosí
-
Mexquitic de Carmona, San Luis Potosí, 멕시코, 78480
- Dif Muncipal de Mexquitic de Carmona
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: NW-AmProt
Group of children with normal weight according to their BMI that receive daily 2g of amaranth protein as diet supplementation
|
Groups of children taken 2 g of amaranth protein isolate daily for 90 days
|
|
활성 비교기: OB-AmProt
Group of children with overweight according to their BMI that receive daily 2g of amaranth protein as diet supplementation
|
Groups of children taken 2 g of amaranth protein isolate daily for 90 days
|
|
활성 비교기: OW-AmProt
Group of children with obesitty according to their BMI that receive daily 2g of amaranth protein as diet supplementation
|
Groups of children taken 2 g of amaranth protein isolate daily for 90 days
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fecal DNA extraction and 16S rRNA gene sequencing sing the V4-V5 region of the 16S rRNA gene.
기간: Samples were taken at the beginning and after 90 days
|
Number of ASVs in each analyzed group, alfa and beta diversity, ASVs abundance
|
Samples were taken at the beginning and after 90 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Measurements of fecal Short Chain Fatty Acids (SCFAs) levels
기간: Samples were taken at the beginning and after 90 days
|
Data of mg/g of acetic, propionic, butyric acids and total SCFAs
|
Samples were taken at the beginning and after 90 days
|
|
Hematological and biochemical serum analyses
기간: 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)
|
3 months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Monica L Rangel Martinez, MD, Servicios de Salud de San Luis Potosi
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SLP/006-2018
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .