Effect of a Novel Blend of Plant Protein and Additional Ingredients on Resistance Training Adaptations

NCT06908811 | Completed

• 1 other identifier: IRB-22-67
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to compare the observed changes in resistance training adaptations (strength, performance, body composition, recovery, and lactate responses) after supplementation of isocaloric and isonitrogenous amounts of a novel plant protein formulation against changes observed in a pea/rice plant protein blend, whey protein, and a carbohydrate placebo in healthy resistance-trained men and women between the ages of 18-39.

Conditions

Resistance Exercise

Outcome Measures

Primary Outcomes (10)

• Change in 4-Compartment Lean Mass

  Lean mass will be assessed using a 4-compartment model, which includes measurements of body density, total body water, and bone mineral content.

  Week 0, Week 4, and Week 8

• Change in Perceptual Indicators of Training State

  Participants will rate their readiness to train, soreness, recovery, energy, and sleep quality using 100-mm visual analog scales. Each scale is anchored with contextually appropriate statements such as "Lowest Possible" and "Highest Possible."

  Week 0, Week 4, and Week 8

• Change in Profile of Mood States (POMS) Score

  Mood state will be assessed using the Profile of Mood States (POMS) questionnaire, a validated tool for measuring transient affective states. The POMS consists of six subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment), with a Total Mood Disturbance (TMD) score calculated by summing negative subscale scores and subtracting the Vigor score. Higher TMD scores indicate greater mood disturbance, while lower scores indicate improved mood state.

  Week 0, Week 4, and Week 8

• Change in Pressure to Pain Threshold

  Pressure pain threshold will be assessed using a digital algometer to determine the minimum pressure required to elicit pain. Higher scores indicate higher tolerance to pain.

  Week 0, Week 4, and Week 8

• Change in Handgrip Strength

  Maximal handgrip strength will be assessed using a calibrated hand dynamometer. Higher values indicate greater strength.

  Week 0, Week 4, and Week 8

• Change in Isometric Mid-Thigh Pull Force

  Maximal force output will be assessed using an isometric mid-thigh pull on a force plate, measured in Newtons. Higher scores equal greater force production

  Week 0, Week 4, and Week 8

• Change in Hex Bar Deadlift One-Repetition Maximum (1RM)

  Maximal hex bar deadlift strength will be assessed using a standardized one-repetition maximum (1RM) test.

  Week 0, Week 4, and Week 8

• Change in Bench Press One-Repetition Maximum (1RM

  Maximal upper-body strength will be assessed using a standardized one-repetition maximum (1RM) bench press test.

  Week 0, Week 4, and Week 8

• Change in Isokinetic Peak Knee Extension Torque

  Peak torque of the quadriceps will be assessed using an isokinetic dynamometer. Higher values indicate greater knee extensor strength.

  Week 0, Week 4, and Week 8

• Performance in 5 Sets of Hex Bar Deadlift Protocol

  Strength endurance will be assessed using a hex bar deadlift protocol consisting of 3 sets of 10 repetitions at 70% 1RM and 2 sets to failure at 80% 1RM. Repetition count and total volume lifted will be recorded.

  Week 0, Week 4, and Week 8

Secondary Outcomes (5)

• Change in 4-Compartment Fat Mass

  Week 0, Week 4, and Week 8

• Change in 4-Compartment Fat-Free Mass

  Week 0, Week 4, and Week 8

• Change in 4-Compartment Percent Body Fat

  Week 0, Week 4, and Week 8

• Change in Total, Extracellular, and Intracellular Body Water

  Week 0, Week 4, and Week 8

• Change in Dry Fat-Free Mass

  Week 0, Week 4, and Week 8

Study Arms (4)

Novel Plant Protein

EXPERIMENTAL

Novel plant protein blend containing 30 grams of protein taken twice per day for 8 weeks

Dietary Supplement: Novel Plant Protein Blend

Pea/Rice Protein

ACTIVE COMPARATOR

Pea/Rice protein blend containing 30 grams of protein taken twice per day for 8 weeks

Dietary Supplement: Pea/Rice Protein Blend

Whey Protein

ACTIVE COMPARATOR

Whey protein blend containing 30 grams of protein taken twice per day for 8 weeks

Dietary Supplement: Whey Protein

Carbohydrate Placebo

PLACEBO COMPARATOR

Carbohydrate placebo (maltodextrin) taken twice per day for 8 weeks

Dietary Supplement: Carbohydrate Placebo

Interventions

Novel Plant Protein Blend DIETARY_SUPPLEMENT

Novel plant protein blend containing 30 grams of protein.

Novel Plant Protein

Pea/Rice Protein Blend DIETARY_SUPPLEMENT

Pea/Rice protein blend containing 30 grams of protein

Pea/Rice Protein

Whey Protein DIETARY_SUPPLEMENT

Whey concentrate protein blend containing 30 grams of protein

Whey Protein

Carbohydrate Placebo DIETARY_SUPPLEMENT

Maltodextrin placebo

Carbohydrate Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-39 years
• Participants will be healthy and free of disease as determined by evaluation of a medical history
• All participants will be required to abstain from taking any additional forms of nutritional supplementation deemed to be ergogenic or that will impact resistance training adaptations (pre-workouts, creatine, beta-alanine, etc.) for four weeks prior to beginning this study and for the entire duration of the study.

You may not qualify if:

• Those individuals less than 18 and greater than 39 years of age will be excluded.
• Participants who are determined to not be weight stable defined as pre-study and visit 1 body mass levels deviating by 3% or more.
• Any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease.
• Body mass index \>29.9 kg/m2. Males with a body mass index greater than 29.9 kg/m2, but a body fat percentage less than 27.5% fat will be accepted into the study. Females with a body mass index greater than 29.9 kg/m2, but a body fat percentage less than 32.5% fat will be accepted into the study. The average body mass index for the entire study cohort will be less than 27.5 kg/m2. As such, an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 27.5 kg/m2
• Individuals who present with any previous injury or illness that would prevent them from appropriately completing all exercise lifts.
• Participants who are not able to fit onto the DEXA table will not be able to participate in the research due to size restrictions of the equipment. This typically includes individuals exceeding 400 pounds or those greater than 6'4".
• Those individuals with less than 3 months of structured resistance training, aerobic training, or team sport participation experience will be excluded from the study.
• Pregnant women, women trying to become pregnant, or nursing women. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chad Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Supplements were blinded, in labeled containers. Each supplement will be of a similar volume, texture, and flavor, and labeled in indistinguishable packaging to ensure blinding.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled, Parallel Design

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: August 19, 2022
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)