Resistance ExerciseIOVNCT06908811
Effect of a Novel Blend of Plant Protein and Additional Ingredients on Resistance Training Adaptations
A study testing Novel Plant Protein Blend, Pea/Rice Protein Blend and Whey Protein in people with Resistance Exercise, run by Lindenwood University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistance Exercise
- What is being tested?
- Novel Plant Protein Blend, Pea/Rice Protein Blend and Whey Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2022to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
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.
Read the 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.
- Conditions
- Resistance Exercise
- Being tested
- Novel Plant Protein Blend, Pea/Rice Protein Blend, Whey Protein, Carbohydrate Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Plant Protein BlendDietary supplement
Novel plant protein blend containing 30 grams of protein.
Pea/Rice Protein BlendDietary supplement
Pea/Rice protein blend containing 30 grams of protein
Whey ProteinDietary supplement
Whey concentrate protein blend containing 30 grams of protein
Carbohydrate PlaceboDietary supplement
Maltodextrin placebo
| Study group | Role | What they receive |
|---|---|---|
| Novel Plant Protein | Experimental | Novel plant protein blend containing 30 grams of protein taken twice per day for 8 weeks Receives: 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 Receives: 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 Receives: Dietary Supplement: Whey Protein |
| Carbohydrate Placebo | Placebo comparator | Carbohydrate placebo (maltodextrin) taken twice per day for 8 weeks Receives: Dietary Supplement: Carbohydrate Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, Week 4, and Week 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start19 Aug 2022
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908811
- Sponsor's protocol ID
- IRB-22-67
- Acronym
- IOV
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Blend of Plant Protein and Additional Ingredients on Resistance Training Adaptations
- ClinicalTrials.gov ID
- NCT06908811
- Acronym / sponsor ID
- IOV / IRB-22-67
- Conditions
- Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Design
| Arm | Type | Receives |
|---|---|---|
| Novel Plant Protein | Experimental | Dietary Supplement: Novel Plant Protein BlendNovel plant protein blend containing 30 grams of protein taken twice per day for 8 weeks |
| Pea/Rice Protein | Active comparator | Dietary Supplement: Pea/Rice Protein BlendPea/Rice protein blend containing 30 grams of protein taken twice per day for 8 weeks |
| Whey Protein | Active comparator | Dietary Supplement: Whey ProteinWhey protein blend containing 30 grams of protein taken twice per day for 8 weeks |
| Carbohydrate Placebo | Placebo comparator | Dietary Supplement: Carbohydrate PlaceboCarbohydrate placebo (maltodextrin) taken twice per day for 8 weeks |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Plant Protein BlendNovel plant protein blend containing 30 grams of protein. | Dietary supplement | Novel Plant Protein |
| Pea/Rice Protein BlendPea/Rice protein blend containing 30 grams of protein | Dietary supplement | Pea/Rice Protein |
| Whey ProteinWhey concentrate protein blend containing 30 grams of protein | Dietary supplement | Whey Protein |
| Carbohydrate PlaceboMaltodextrin placebo | Dietary supplement | Carbohydrate Placebo |
Primary outcome
Change in 4-Compartment Lean Mass
Time frame: Week 0, Week 4, and Week 8
Lean 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 State
Time frame: Week 0, Week 4, and Week 8
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."
Change in Profile of Mood States (POMS) Score
Time frame: Week 0, Week 4, and Week 8
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.
Change in Pressure to Pain Threshold
Time frame: Week 0, Week 4, and Week 8
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.
Change in Handgrip Strength
Time frame: Week 0, Week 4, and Week 8
Maximal handgrip strength will be assessed using a calibrated hand dynamometer. Higher values indicate greater strength.
Change in Isometric Mid-Thigh Pull Force
Time frame: Week 0, Week 4, and Week 8
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
Change in Hex Bar Deadlift One-Repetition Maximum (1RM)
Time frame: Week 0, Week 4, and Week 8
Maximal hex bar deadlift strength will be assessed using a standardized one-repetition maximum (1RM) test.
Change in Bench Press One-Repetition Maximum (1RM
Time frame: Week 0, Week 4, and Week 8
Maximal upper-body strength will be assessed using a standardized one-repetition maximum (1RM) bench press test.
Change in Isokinetic Peak Knee Extension Torque
Time frame: Week 0, Week 4, and Week 8
Peak torque of the quadriceps will be assessed using an isokinetic dynamometer. Higher values indicate greater knee extensor strength.
Performance in 5 Sets of Hex Bar Deadlift Protocol
Time frame: Week 0, Week 4, and Week 8
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.
5 secondary outcomes
Change in 4-Compartment Fat Mass
Time frame: Week 0, Week 4, and Week 8
Change in 4-Compartment Fat-Free Mass
Time frame: Week 0, Week 4, and Week 8
Change in 4-Compartment Percent Body Fat
Time frame: Week 0, Week 4, and Week 8
Change in Total, Extracellular, and Intracellular Body Water
Time frame: Week 0, Week 4, and Week 8
Change in Dry Fat-Free Mass
Time frame: Week 0, Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Plant Protein Blend, Pea/Rice Protein Blend and Whey Protein in people with Resistance Exercise, run by Lindenwood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 4-Compartment Lean Mass (time frame: Week 0, Week 4, and Week 8). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.