- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420933
Pea vs Whey Protein Supplementation With Resistance Training on Young Adults' Strength, Body Composition, and Metabolic Parameters
The Effect of Pea Protein Supplementation on Muscle Hypertrophy and Metabolic Parameters in Young Adults Following an 8-week Resistance Training Program
The goal of this clinical trial is to compare the impact of pea protein or whey protein supplementation during a progressive resistance exercise (PRE) regimen on body composition and strength in young adults who are not undergoing regular strength training. The main questions it aims to answer are:
- Do lean body mass changes differ between supplement groups following a progressive resistance exercise PRE training program?
- Does improvements in muscle strength differ between groups following a PRE training program?
- Does glucose, insulin, and essential amino acid appearance and clearance rate differ between groups following a PRE training program? Researchers will compare pea protein supplementation to whey protein supplementation to see if there are any differences in body composition and strength
Participants will:
- Consume Pea or Whey protein supplement twice daily for 8 weeks
- Participate in a PRE training program twice weekly for approximately 1.5 hours per day
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77008
- Texas Woman's University Institute of Health Sciences Houston Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy Adults 18-30y
- BMI between 18.5 - 28 kg/m**2
The subjects will be excluded if:
- they have a history or current diagnosis of cardiovascular disease, cancer, diabetes, gastrointestinal disorders, or metabolic disorders.
- they use tobacco products
- consume alcohol as defined as >2 drinks per day,
- follow a special diet
- reported recent significant body weight changes (>5% prior 3 months)
- report an intolerance or allergy to ingredients in the supplements.
- report regular consumption of other muscle or metabolic stimulating products or drugs such as creatine, other amino acids or protein supplements, growth hormone or derivatives, or ergogenic aids including steroids.
- if they answer "no" to any question on the Physical Activity Readiness Questionnaire which would indicate that the subject cannot safely participate in an exercise program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pea Protein
Participants in this arm will consume pea protein isolate (24g/sachet) twice daily for 8 weeks while participating in an 8-week PRE program (2, 1.5hr sessions per week)
|
Participants in this arm will consume protein isolate (24g/sachet) twice daily for 8 weeks.
Based on the resistance training guidelines from the American College of Sports Medicine, each subject will attend two supervised resistance training sessions weekly for a duration of 8 weeks. A minimum two day rest between PRE sessions will be required. Twelve exercises that targets each major muscle group will be conducted at each exercise session in the order listed below:
|
|
Active Comparator: Whey Protein
Participants in this arm will consume whey protein isolate (24g/sachet) twice daily for 8 weeks while participating in an 8-week PRE program (2, 1.5hr sessions per week)
|
Participants in this arm will consume protein isolate (24g/sachet) twice daily for 8 weeks.
Based on the resistance training guidelines from the American College of Sports Medicine, each subject will attend two supervised resistance training sessions weekly for a duration of 8 weeks. A minimum two day rest between PRE sessions will be required. Twelve exercises that targets each major muscle group will be conducted at each exercise session in the order listed below:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in body composition
Time Frame: Baseline and 8 weeks
|
Differences in lean mass (kg, kg/m^2, and % total mass) and fat mass (kg, and % total mass) assessed using Dual Energy X-ray Absorptiometry (DXA; Horizon W, Hologic, Marlborough, MA)
|
Baseline and 8 weeks
|
|
Difference in muscle strength
Time Frame: Baseline and 8 weeks
|
Differences in muscle strength assessed by maximal isometric force produced by quadriceps (Nm) using a Biodex System 3 dynamometer, hand grip (kg) using a handgrip dynamometer, 1-Rep Max for chest press (kg), and 1-Rep Max for leg press (kg)
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional Metabolic Biomarkers
Time Frame: Baseline and 8 weeks
|
Differences in essential amino acid (Histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) cMax and iAUC, glucose (cMax and iAUC), and insulin (cMax and iAUC) will be measured from plasma following a protein load (0.3 g/kg body weight of pea- or whey-protein isolate)
|
Baseline and 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting Metabolic Rate
Time Frame: Baseline and 8 weeks
|
Differences in Resting Metabolic Rate (kcal/d) will be measured using indirect calorimetry (Parvo Medics TrueOne 2400, Parvo Medics, Sandy, UT)
|
Baseline and 8 weeks
|
|
Blood Pressure
Time Frame: Baseline and 8 weeks
|
Systolic (mmHg) and diastolic (mmHg) blood pressure measured using digital blood pressure monitor (Spot Vital Signs 4200B, Welch Allyn, Skaneateles Falls, NY)
|
Baseline and 8 weeks
|
|
Weight status
Time Frame: Baseline and 8 weeks
|
Body Mass Index (kg/m**2) calculated from measured body weight (kg) and height (cm) using digital scale and stadiometer, respectively.
Body weight (kg)
|
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PProtRCT-FY2019-182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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