Plant-Based Protein for Healthy Nutrition

(PBP Trial)

Recruiting at 1 trial location

Overseen By Changhyun Lim, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Analgesics, Anti-inflammatories, Corticosteroids, others

Disqualifiers: Neuromuscular problems, Metabolic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

8 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you are not currently using analgesic or anti-inflammatory drugs, corticosteroids, hormonal contraceptives, or anabolic steroids. If you are taking any of these, you would need to stop before participating.

What data supports the effectiveness of the treatment Protein Quality in the clinical trial 'Plant-Based Protein for Healthy Nutrition'?

Research shows that adding high-quality plant protein sources to a vegan diet can improve protein quality, helping to meet essential amino acid needs. This suggests that plant-based proteins can be an effective part of a healthy diet, potentially offering health benefits like reduced cardiovascular risk and better satiety. ^{1 2 3 4 5}

Is plant-based protein generally safe for human consumption?

Research suggests that plant-based proteins are generally safe for human consumption and may offer health benefits similar to animal proteins. However, they may have lower essential amino acid content, which can be addressed by consuming a variety of plant proteins or fortifying them with specific amino acids. ^{1 3 5 6 7}

How does the treatment 'Plant-Based Protein for Healthy Nutrition' differ from other treatments for protein quality?

This treatment is unique because it focuses on using high-quality plant-based proteins to improve protein quality in diets, which can help meet essential amino acid requirements without relying on animal proteins. It emphasizes the environmental and ethical benefits of plant proteins, while also addressing potential health benefits such as reduced cardiovascular risk and increased satiety. ^{1 3 5 8 9}

Research Team

Stuart Phillips, PhD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for healthy non-smokers aged 18-30 with a BMI of 18-30 kg/m2. Participants must have regular menstrual cycles without hormonal contraceptives if female, and be in good health as confirmed by a questionnaire. Those using steroids, analgesics, anti-inflammatories or corticosteroids, or with chronic illness or muscle diseases cannot join.

Inclusion Criteria

Be in general good health as assessed by a general health questionnaire

Have a body mass index (BMI) between 18-30 kg·m2 (inclusive)

Regular menstrual cycle and not using hormonal contraceptives

Exclusion Criteria

I am currently taking painkillers or anti-inflammatory medication.

I have a long-term health condition or a recent illness.

I have a history of muscle or bone diseases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume test drinks containing either whey protein isolate, plant-based protein isolate, or plant-based protein isolate with leucine to assess muscle protein synthesis and other responses.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscle protein synthesis, aminoacidemia, and tolerability.

5 hours

1 visit (in-person)

Treatment Details

Interventions

• Protein Quality

Trial Overview The study is testing how well a new plant-based protein blend helps build muscle compared to whey protein isolate. It's designed to see if the plant protein can match the muscle-building response that whey protein typically produces.

Participant Groups

Group I: Whey protein isolate Experimental Treatment 1 Intervention

Whey protein isolate is the 'gold standard' of protein supplements due to being rich in essential amino acids and leucine. Leucine is a key amino acid the is required to stimulate muscle protein synthesis. Muscle protein synthesis is the major mechanism the underpins muscle growth. The whey protein would ostensibly serve as a positive control.

Group II: Plant based protein isolate + leucine Experimental Treatment 1 Intervention

Enriching plant-based protein with leucine will increase the 'quality' of said protein source and theoretically should have similar muscle protein synthetic responses to whey protein.

Group III: Plant based protein isolate Experimental Treatment 1 Intervention

Current plant-based protein isolates available contain insufficient amounts of leucine, and are less digestible, resulting in a reduced muscle protein synthesis responses. The plant based protein would ostensibly serve as a negative control.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Protein Quality Changes of Vegan Day Menus with Different Plant Protein Source Compositions. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The value of dietary plant protein in older people. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Plant Proteins: Assessing Their Nutritional Quality and Effects on Health and Physical Function. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Plant-Based Protein Consumption on Kidney Function and Mineral Bone Disorder Outcomes in Adults With Stage 3-5 Chronic Kidney Disease: A Systematic Review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Plant Proteins: Methods of Quality Assessment and the Human Health Benefits of Pulses. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring Health-Promoting Attributes of Plant Proteins as a Functional Ingredient for the Food Sector: A Systematic Review of Human Interventional Studies. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

The Anabolic Response to Plant-Based Protein Ingestion. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

True ileal digestibility of legumes determined by dual-isotope tracer method in Indian adults. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Plant proteins in relation to human protein and amino acid nutrition. [2018]