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临床试验/NCT07289867
NCT07289867已完成不适用

Nutritional Effects of Supplementing Nonagenarians With a Supplement Based on a Fruit From the Cerrado: Buriti

Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Change in Body Weight

研究概览

简要总结

The population aged over 90 is growing worldwide, and the search for strategies to promote a better quality of life for the older persons is a challenge for science. Advancing age is associated with several physiological changes leading to different diseases, among which malnutrition and sarcopenia stand out. Malnutrition prevention and treatment are based on functional food/nutritional interventions, such as oral supplement use. However, studies evaluating the effectiveness of these supplements in nonagenarians are still scarce in the literature. The present study aimed to evaluate the use of a buriti fruit (Mauritia flexuosa) supplement in persons 90 years and older. The study included 40 individuals who were randomized into two groups. The group Supplement Test (ST) used a Buriti-based supplement with full vitamins and minerals; the control group used a capsule containing the same composition of vitamins and minerals as the test supplement, which was called Vitamin Mix (VM). The intervention lasted 12 weeks. The following analyses were carried out before and after this period: Mini Nutritional Assessment (MNA) questionnaire, handgrip strength (HGS), biochemical tests, and anthropometric measurements. The main results showed that the Buriti supplement led to a significant increase in body weight, Body Mass Index (BMI), handgrip strength, and globulins, when compared to the group that used the vitamin mix. Therefore, it can be concluded that the buriti supplement promotes an improvement in body composition, increased strength, and globulins in nonagenarians, and may be a viable and effective strategy for malnutrition treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
90 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged 90 or over were selected from the database of the Reference Center for Elderly Health Care in Montes Claros, MG .

排除标准

  • Exclusion criteria included severe obesity, decompensated chronic diseases, or inability/refusal to consent.

结局指标

主要结局

Change in Body Weight

时间窗: Baseline and after 12 weeks of supplementation

Body weight (kg) was measured using a calibrated digital scale to evaluate changes after supplementation.

Change in Muscle Strength

时间窗: Baseline and after 12 weeks of supplementation.

Muscle strength was assessed using a handgrip dynamometer to evaluate functional improvement following 12 weeks of supplementation.

Change in Body Weight

时间窗: Baseline and after 12 weeks of supplementation

Body weight (kg) was measured using a calibrated digital scale to evaluate changes after supplementation.

Change in Muscle Strength

时间窗: Baseline and after 12 weeks of supplementation.

Muscle strength was assessed using a handgrip dynamometer to evaluate functional improvement following 12 weeks of supplementation.

次要结局

  • Change in Body Mass Index(Baseline and after 12 weeks of supplementation.)
  • Change in Serum Globulin Levels(Baseline and after 12 weeks of supplementation.)
  • Change in Body Weight(Baseline and after 12 weeks of supplementation)
  • Change in Body Mass Index(Baseline and after 12 weeks of supplementation.)
  • Change in Body Weight(Baseline and after 12 weeks of supplementation)
  • Change in Serum Globulin Levels(Baseline and after 12 weeks of supplementation.)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sergio Henrique Sousa Santos

Professor / principal investigator

Federal University of Minas Gerais

研究点 (2)

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