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临床试验/NCT06610253
NCT06610253已完成不适用

Evaluation of the Impact of the Consumption of Plant-derived Protein Supplements Compared to Animal-derived Proteins and in Relation to the Metabolic State and Body Composition of People Practicing Physical Activity.

University of Warmia and Mazury in Olsztyn2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月30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
60
试验地点
2
主要终点
analysis of selected blood biochemical parameters - electrolytes (Na, K, Cl)

研究概览

简要总结

The goal of the study is to evaluate how the consumption of plant-based protein supplements compares to animal-based protein supplements in terms of their effects on metabolic state and body composition in individuals who engage in physical activity.

The increasing awareness of the health advantages of plant-based foods and the rising number of health-conscious consumers are driving the demand for plant-based supplements. Furthermore, there is a tendency for consumers to favor vegetable proteins over animal proteins.

The effect of total protein intake and its various sources on gains in lean body mass and strength in response to resistance training has been extensively studied. However, most research has focused on comparing soy protein preparations to animal-derived preparations, primarily whey protein and casein. Studies suggest that whey protein, which has a higher leucine content, may stimulate muscle protein synthesis more effectively than soy and casein. It is unclear to what extent the type of protein supplement affects strength and lean body mass in studies lasting six weeks or longer. Pea and rice proteins may be suitable replacements for highly allergenic soy protein. Consequently, there is a need for research to assess the impact of these products on human metabolic state and overall health and well-being.

详细描述

Dietary supplements are commonly used foodstuffs. For a long time, supplements were used mainly by people practicing sports professionally. An increasing number of supplements are dedicated to people for whom sport comes down to health-promoting physical activity. At the same time, cultural, ethical, and environmental trends encourage society to reduce animal products and use plant-based alternatives. The size of the global dietary supplement market was valued at USD 151.9 billion in 2021. It is projected to grow at an average annual rate (CAGR) of 8.9% between 2022 and 2030. Forecasts assume that consumer demand for protein supplements and amino acid products, such as creatine, tyrosine, and citrulline, will guarantee the segment of proteins and amino acids the highest share in CAGR at the level of 13.4%.

Such a dynamic trend brings with it several questions that pose new challenges to the world of science. Can protein products of plant origin compete with the preparations based on proteins of animal origin, which have been present for many years? What effects can the investigators expect from systematic supplementation of vegetable proteins? Which of the vegetable proteins is the best substitute for proteins of animal origin, and does supplementation with vegetable proteins carry no additional risks? In the study, the investigators want to compare four protein preparations: whey protein, pea protein, rice protein, and a preparation composed of pea and rice protein mixed in the right proportion to increase its biological value by complementing the limiting amounts of amino acids. Pea and rice proteins may be a promising replacement for highly allergenic proteins such as soy protein. Therefore, there is a need to research the assessment of the impact of these products on the metabolic state of humans in terms of health and quality of life.

Another research aspect regarding the consumption of proteins of various origins is the assessment of their impact on the intestinal microbiota profile. In recent years, the number of scientific publications on the role of intestinal microbiota in shaping human health has been increasing. It is now known that the intestinal microbiota is not only involved in the processes related to the digestion and absorption of nutrients. Bacteria included in the intestinal microbiota perform various functions, and their proper quantitative and qualitative structure supports the homeostasis of the whole organism, shaping immunity, metabolism, and the synthesis of many chemical compounds.

Research hypotheses:

  1. Protein preparations of vegetable origin (rice protein isolate, pea protein isolate) when covering the demand for leucine (protein from food + preparation) will not show significant differences in body composition compared to a protein preparation of animal origin (WPC).
  2. The combination of the intervention with the preparations (pea and rice proteins), due to the reduction in the amount of limiting amino acids, will have a more favorable effect on the total protein utilization than the separate intervention with the preparation of rice protein and pea protein.
  3. Increased protein supply will help reduce muscle mass loss during intense physical exercise.
  4. A diet enriched with a protein preparation affects the biochemical parameters of the blood and the microbiota profile.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy men aged 18-40, practicing systematic physical activity at least twice a week.

排除标准

  • food allergies to milk, pea and rice proteins.

结局指标

主要结局

analysis of selected blood biochemical parameters - electrolytes (Na, K, Cl)

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

The measurement electrolytes (Na, K, Cl) will be performed by the MFA Analytical Laboratory in Olsztyn. Result values will be expressed in units - mmol/l

analysis of selected blood biochemical parameters - lipid profile

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

The measurement of lipid profile (HDL,LDL, non HDL, triglycerides) will be performed by the MFA Analytical Laboratory in Olsztyn. Result values will be expressed in units - mg/dl

analysis of selected blood biochemical parameters - liver condition

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

The measurement of liver condition (ASPAT, ALAT, GGTP, LDH) will be performed by the MFA Analytical Laboratory in Olsztyn. Result values will be expressed in units - U/L

analysis of selected blood biochemical parameters - protein metabolism

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

The measurement of serum total protein, total bilirubin, serum urea, serum creatinine, serum uric acid will be performed by the MFA Analytical Laboratory in Olsztyn. Result values will be expressed in units - mg/dl

analysis of the amino acid profile in plasma and urine samples

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

Analysis of the amino acid profile in plasma and urine samples of volunteers collected during the experiment will be carried out using the HPLC-MS method

analysis of the stool samples

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

It will be assessed by next-generation sequencing (NGS) of the bacterial specific 16S rRNA variable region. DNA will be extracted from the samples using the QIAamp Fast DNA Stool Mini Kit (Qiagen) according to the manufacturer's instructions. The extracted DNA will be used to assess the microbiota profile by amplifying the V3-V4 region of the 16S rRNA gene using primers and protocols according to the instructions for preparing the 16S metagenomic sequencing library

body composition analysis - body weight

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

Measurement of body composition parameters - body weight will be performed using the body scale that is part of the Body Composition Analyzer SECA (515mBCA). Body weight will be expressed in units - kilograms, with an accuracy of 0.01 kg

body composition analysis - body high

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

The measurement of body composition parameters - height, will be performed using a validated measure included in the Body Composition Analyzer SECA equipment (515mBCA). Participants' height will be expressed in units - meters with an accuracy of 0.01 m

body composition analysis

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

Measurement of body composition parameters (body fat, total body water, skeletal muscle mass, bone mass will be performed using the bioimpedance method using the Body Composition Analyzer SECA (515mBCA). Parameters will be expressed in units - kilograms, with an accuracy of 0.01 kg and their conversion into percentages of total body weight

body composition analysis - BMI

时间窗: 3 times. at the beginning, after 4 weeks and after 8 weeks

Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms (kg) and height in metres (m).

次要结局

未报告次要终点

研究者

发起方
University of Warmia and Mazury in Olsztyn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bartosz Kroplewski

MSc Eng.

University of Warmia and Mazury in Olsztyn

研究点 (2)

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