Evaluation of the Impact of the Consumption of Plant-derived Protein Supplements Compared to Animal-derived Proteins

NCT06610253 | Completed DMC

• 1 other identifier: 4/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition, Healthy; Body Weight Changes

Keywords

protein; physical activity; pea protein; rice protein; whey protein; plant-derived protein

Outcome Measures

Primary Outcomes (10)

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

  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

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

• analysis of selected blood biochemical parameters - lipid profile

  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

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

• analysis of selected blood biochemical parameters - liver condition

  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

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

• analysis of selected blood biochemical parameters - protein metabolism

  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

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

• analysis of the amino acid profile in plasma and urine samples

  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

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

• analysis of the stool samples

  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

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

• body composition analysis - body weight

  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

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

• body composition analysis - body high

  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

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

• body composition analysis

  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

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

• body composition analysis - BMI

  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).

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

Study Arms (4)

Whey protein

ACTIVE COMPARATOR

Healthy men engaged in physical activity. Daily supplementation with the indicated protein preparation for a period of 8 weeks. Whey group receiving 30g of a preparation containing 80% whey protein concentrate

Dietary Supplement: Protein

Pea protein

EXPERIMENTAL

Healthy men engaged in physical activity. Daily supplementation with the indicated protein preparation for a period of 8 weeks. Pea group receiving 30g of a preparation containing 80% pea protein isolate

Dietary Supplement: Protein

Rice protein

EXPERIMENTAL

Healthy men engaged in physical activity. Daily supplementation with the indicated protein preparation for a period of 8 weeks. Rice group receiving 30g of a preparation containing 80% rice protein isolate

Dietary Supplement: Protein

MIX protein

EXPERIMENTAL

Healthy men engaged in physical activity. Daily supplementation with the indicated protein preparation for a period of 8 weeks. MIX group receiving 30g of a preparation containing 80% rice and pea protein isolate.

Dietary Supplement: Protein

Interventions

Protein DIETARY_SUPPLEMENT

Controlled, randomized, single-blind, parallel-group, prospective. Planned, parallel, randomized, single-blind, controlled clinical trial (RCT). Participants will be randomly assigned to one of four interventions: Whey Protein Concentrate - WPC, Pea Protein Isolate - PPI, Rice Protein ISOLATE - RPI, a combination of PPI and RPI to see if the intervention works together in synergy. The experiment was scheduled for week 8. Each participant will consume 30g of a dedicated preparation every day for 8 weeks. The planned measurements will be performed three times - before the experiment begins, after 4 and 8 weeks.

MIX protein; Pea protein; Rice protein; Whey protein

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• food allergies to milk, pea and rice proteins.

Sponsors & Collaborators

• University of Warmia and Mazury in Olsztyn: lead

Study Sites (1)

University of Warmia and Mazury

Olsztyn, Warmian-Masurian Voivodeship, 10-720, Poland

Location

MeSH Terms

Conditions

Body Weight Changes; Motor Activity

Interventions

Proteins

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Bartosz Kroplewski, MSc, Eng.

  UWM Olsztyn

  PRINCIPAL INVESTIGATOR

• Katarzyna Przybyłowicz, Prof Eng.

  UWM Olsztyn

  STUDY DIRECTOR

• Tomasz Sawicki, PhD, Eng.

  UWM Olsztyn

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Eng.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: September 24, 2024
• Study Start: June 30, 2023
• Primary Completion: September 30, 2023
• Study Completion: April 20, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)