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

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.

Study Overview

• Status: Completed
• Conditions: Resistance Exercise
• Intervention / Treatment: Dietary supplement: Novel Plant Protein Blend; Dietary supplement: Pea/Rice Protein Blend; Dietary supplement: Whey Protein; Dietary supplement: Carbohydrate Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Exercise and Performance Nutrition Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel Plant Protein; Novel plant protein blend containing 30 grams of protein taken twice per day for 8 weeks	Dietary supplement: Novel Plant Protein Blend; Novel plant protein blend containing 30 grams of protein.
Active Comparator: Pea/Rice Protein; Pea/Rice protein blend containing 30 grams of protein taken twice per day for 8 weeks	Dietary supplement: Pea/Rice Protein Blend; Pea/Rice protein blend containing 30 grams of protein
Active Comparator: Whey Protein; Whey protein blend containing 30 grams of protein taken twice per day for 8 weeks	Dietary supplement: Whey Protein; Whey concentrate protein blend containing 30 grams of protein
Placebo Comparator: Carbohydrate Placebo; Carbohydrate placebo (maltodextrin) taken twice per day for 8 weeks	Dietary supplement: Carbohydrate Placebo; Maltodextrin placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 4-Compartment Fat Mass	Fat mass will be measured using a 4-compartment model, which integrates body density, total body water, and bone mineral content.	Week 0, Week 4, and Week 8
Change in 4-Compartment Fat-Free Mass	Fat-free mass will be assessed using a 4-compartment model, providing a more precise measurement of body composition changes.	Week 0, Week 4, and Week 8
Change in 4-Compartment Percent Body Fat	Body fat percentage will be assessed using a 4-compartment model.	Week 0, Week 4, and Week 8
Change in Total, Extracellular, and Intracellular Body Water	Hydration status will be measured using bioelectrical impedance analysis (BIA) to assess total, extracellular, and intracellular body water content.	Week 0, Week 4, and Week 8
Change in Dry Fat-Free Mass	Dry fat-free mass will be assessed using a combination of dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA) for a comprehensive measure of lean tissue mass.	Week 0, Week 4, and Week 8

Collaborators and Investigators

• Sponsor: Lindenwood University
• Investigators: Principal Investigator: Chad Kerksick, PhD, Lindenwood University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB-22-67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No