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Active, Not Recruiting

NCT Number: NCT05139160

Aminoacidemia and Protein Kinetics in Response to the Ingestion of Plant-based Protein Blends

The present investigation aims to study a novel plant based protein isolate blend to determine if it results in similar muscle building responses compared to whey protein isolate.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Nutrition, Healthy

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhyun Lim

Hamilton, Ontario, L8S 4K1, Canada

About this study

Whey protein is considered the 'gold standard' to maintain body proteins (muscle, skin, bone). When isolated from milk, whey protein isolate (WPI) contains all nine essential amino acids (EAA) which are 'building blocks' that are needed to support the maintenance of body proteins. To date, there is no plant-based protein (PBP) isolate that compares to the recommended WPI towards how our body builds or supports our muscles. WPI is considered the 'gold standard' because it contains all of the EAA which provide the right amount of 'building blocks' to support our muscles. Current PBP isolates available contain insufficient amounts of EAA, and are less digestible, resulting in less 'building blocks' available to support our muscles. Recently, plant protein combinations have been designed to provide the right amounts of all the EAAs. Therefore, the aim of the present study is to determine the effects of a novel PBP blend on muscle protein synthesis responses by comparing it to WPI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, between the ages of 18 - 30 years (inclusive)
  • Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)
  • Be in general good health as assessed by a general health questionnaire
  • Non-smoking
  • Regular menstrual cycle and not using hormonal contraceptives
  • Willing and able to provide informed consent

Exclusion criteria

  • Currently using analgesic or anti-inflammatory drugs
  • A history of neuromuscular problems or muscle and/or bone wasting diseases
  • Any acute or chronic illness, metabolic disorders
  • Currently using corticosteroids
  • Use of hormonal contraceptives or anabolic steroids (e.g. testosterone)

Treatment and study plan

Protein quality

Dietary Supplement

the present investigation aims to study a novel protein based protein isolate blend with and without leucine an compared with whey protein isolate to determine its impact aminoacidemia and muscle protein synthesis healthy adults.

Primary outcomes

  1. Muscle protein synthesis

    Time frame: Over a 5 hour period

    A marker of muscle growth

Secondary outcomes

  1. Aminoacidemia

    Time frame: Over a 5 hour period

    Amino acids in the blood

  2. Appetite and desire for specific food types in response to test drinks types H

    Time frame: Immediately before, and 30, 60, 120, 180 and 300 minutes after test drinks are consumed.

    Questionnaire on appetite and palpability of the drinks assessed by a visual analogue scale. 100 mm in length with words anchored at each end, expressing the most positive and the most negative rating used to assess hunger, satiety and fullness. Higher scores mean a better outcome.

  3. Palatability of test drinks

    Time frame: Immediately after test drink are consumed.

    Questionnaire of palatability of test drinks assessed by a visual analogue scale. 100 mm in length with words anchored at each end, expressing the most positive and the most negative rating used to assess visual appeal, smell, taste, aftertaste and palatability. Higher scores mean a better outcome.

  4. Questionnaire on safety

    Time frame: Over a 5 hour period

    Safety will be measured via a questionnaire; e.g. can the participant drink the test drinks and are they okay? Yes or no.

  5. Tolerability of test drinks

    Time frame: Over a 5 hour period

    Tolerability will be measured using Visual Analog Scales anchored by the following descriptors: 0 - no symptoms at all; 100 - worst symptoms participant has ever experienced for the following: nausea, belching, feeling of fullness, vomiting, abdominal distension, flatulence, diarrhoea, dry mouth, and thirst.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Acronym: PBP

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Dec 1, 2021
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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