Clinical trial NCT06908811: Effect of a Novel Blend of Plant Protein and Additional Ingredients on Resistance Training Adaptations
Official title: Effect of a Novel Blend of Plant Protein and Additional Ingredients on Resistance Training Adaptations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Exercise
Lead sponsor: Lindenwood University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel Design
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in 4-Compartment Lean Mass
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Perceptual Indicators of Training State
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Profile of Mood States (POMS) Score
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Pressure to Pain Threshold
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Handgrip Strength
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Isometric Mid-Thigh Pull Force
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Hex Bar Deadlift One-Repetition Maximum (1RM)
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Bench Press One-Repetition Maximum (1RM
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Isokinetic Peak Knee Extension Torque
timeFrame: Week 0, Week 4, and Week 8
measure: Performance in 5 Sets of Hex Bar Deadlift Protocol
timeFrame: Week 0, Week 4, and Week 8
Secondary outcomes:
measure: Change in 4-Compartment Fat Mass
timeFrame: Week 0, Week 4, and Week 8
measure: Change in 4-Compartment Fat-Free Mass
timeFrame: Week 0, Week 4, and Week 8
measure: Change in 4-Compartment Percent Body Fat
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Total, Extracellular, and Intracellular Body Water
timeFrame: Week 0, Week 4, and Week 8
measure: Change in Dry Fat-Free Mass
timeFrame: Week 0, Week 4, and Week 8
Other outcomes:
Locations:
city: St. Charles
country: United States
facility: Exercise and Performance Nutrition Laboratory
state: Missouri
Study officials:
affiliation: Lindenwood University
name: Chad Kerksick, PhD
role: PRINCIPAL_INVESTIGATOR
References: