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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06908811
Acronym
IOV
Enrollment
60
Registered
2025-04-03
Start date
2022-08-19
Completion date
2025-01-17
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistance Exercise

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.

Interventions

DIETARY_SUPPLEMENTNovel Plant Protein Blend

Novel plant protein blend containing 30 grams of protein.

DIETARY_SUPPLEMENTPea/Rice Protein Blend

Pea/Rice protein blend containing 30 grams of protein

DIETARY_SUPPLEMENTWhey Protein

Whey concentrate protein blend containing 30 grams of protein

DIETARY_SUPPLEMENTCarbohydrate Placebo

Maltodextrin placebo

Sponsors

Lindenwood University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

Randomized, Double-Blind, Placebo-Controlled, Parallel Design

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Performance in 5 Sets of Hex Bar Deadlift ProtocolWeek 0, Week 4, and Week 8Strength 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.
Change in Handgrip StrengthWeek 0, Week 4, and Week 8Maximal handgrip strength will be assessed using a calibrated hand dynamometer. Higher values indicate greater strength.
Change in Isometric Mid-Thigh Pull ForceWeek 0, Week 4, and Week 8Maximal force output will be assessed using an isometric mid-thigh pull on a force plate, measured in Newtons. Higher scores equal greater force production
Change in Hex Bar Deadlift One-Repetition Maximum (1RM)Week 0, Week 4, and Week 8Maximal hex bar deadlift strength will be assessed using a standardized one-repetition maximum (1RM) test.
Change in Bench Press One-Repetition Maximum (1RMWeek 0, Week 4, and Week 8Maximal upper-body strength will be assessed using a standardized one-repetition maximum (1RM) bench press test.
Change in Isokinetic Peak Knee Extension TorqueWeek 0, Week 4, and Week 8Peak torque of the quadriceps will be assessed using an isokinetic dynamometer. Higher values indicate greater knee extensor strength.
Change in 4-Compartment Lean MassWeek 0, Week 4, and Week 8Lean mass will be assessed using a 4-compartment model, which includes measurements of body density, total body water, and bone mineral content.
Change in Perceptual Indicators of Training StateWeek 0, Week 4, and Week 8Participants 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.
Change in Profile of Mood States (POMS) ScoreWeek 0, Week 4, and Week 8Mood 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.
Change in Pressure to Pain ThresholdWeek 0, Week 4, and Week 8Pressure 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.

Secondary

MeasureTime frameDescription
Change in 4-Compartment Percent Body FatWeek 0, Week 4, and Week 8Body fat percentage will be assessed using a 4-compartment model.
Change in Total, Extracellular, and Intracellular Body WaterWeek 0, Week 4, and Week 8Hydration status will be measured using bioelectrical impedance analysis (BIA) to assess total, extracellular, and intracellular body water content.
Change in 4-Compartment Fat MassWeek 0, Week 4, and Week 8Fat mass will be measured using a 4-compartment model, which integrates body density, total body water, and bone mineral content.
Change in Dry Fat-Free MassWeek 0, Week 4, and Week 8Dry 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.
Change in 4-Compartment Fat-Free MassWeek 0, Week 4, and Week 8Fat-free mass will be assessed using a 4-compartment model, providing a more precise measurement of body composition changes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026