Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:39 PM
Study NCT ID:
NCT07420933
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pea vs Whey Protein Supplementation With Resistance Training on Young Adults' Strength, Body Composition, and Metabolic Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resting Metabolic Rate', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Differences in Resting Metabolic Rate (kcal/d) will be measured using indirect calorimetry (Parvo Medics TrueOne 2400, Parvo Medics, Sandy, UT)'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Systolic (mmHg) and diastolic (mmHg) blood pressure measured using digital blood pressure monitor (Spot Vital Signs 4200B, Welch Allyn, Skaneateles Falls, NY)'}, {'measure': 'Weight status', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Body Mass Index (kg/m\\*\\*2) calculated from measured body weight (kg) and height (cm) using digital scale and stadiometer, respectively. Body weight (kg)'}], 'primaryOutcomes': [{'measure': 'Difference in body composition', 'timeFrame': 'Baseline and 8 weeks', 'description': '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)'}, {'measure': 'Difference in muscle strength', 'timeFrame': 'Baseline and 8 weeks', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Nutritional Metabolic Biomarkers', 'timeFrame': 'Baseline and 8 weeks', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pea protein isolate', 'whey protein isolate', 'progressive resistance exercise', 'body composition', 'strength', 'essential amino acid'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': '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:\n\n1. Do lean body mass changes differ between supplement groups following a progressive resistance exercise PRE training program?\n2. Does improvements in muscle strength differ between groups following a PRE training program?\n3. 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\n\nParticipants will:\n\n* Consume Pea or Whey protein supplement twice daily for 8 weeks\n* Participate in a PRE training program twice weekly for approximately 1.5 hours per day', 'detailedDescription': 'Adequate dietary protein intake is essential for maximizing skeletal muscle hypertrophy and strength gains during progressive resistance exercise (PRE) training. Whey protein isolate is commonly used to support these adaptations; however, there is limited clinical evidence comparing plant-based protein supplements with whey protein when protein dose is controlled and combined with structured resistance training. Pea protein isolate represents a sustainable, plant-based alternative, but its effectiveness in promoting muscle accretion, strength, and metabolic responses relative to whey protein isolate has not been fully characterized. Therefore, this study will compare the effects of pea protein isolate and whey protein isolate supplementation on changes in lean body mass, muscle strength, and postprandial metabolic responses in healthy, untrained young adult males. Participants will be randomized in a double-blind, parallel-group design to consume either pea protein isolate or whey protein isolate for 8 weeks while completing a supervised, PRE training program. Lean body mass and strength outcomes will be assessed before and after the intervention, and acute postprandial essential amino acid, glucose, and insulin responses will be evaluated following standardized protein ingestion at baseline and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Adults 18-30y\n* BMI between 18.5 - 28 kg/m\\*\\*2\n\nThe subjects will be excluded if:\n\n* they have a history or current diagnosis of cardiovascular disease, cancer, diabetes, gastrointestinal disorders, or metabolic disorders.\n* they use tobacco products\n* consume alcohol as defined as \\>2 drinks per day,\n* follow a special diet\n* reported recent significant body weight changes (\\>5% prior 3 months)\n* report an intolerance or allergy to ingredients in the supplements.\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT07420933', 'briefTitle': "Pea vs Whey Protein Supplementation With Resistance Training on Young Adults' Strength, Body Composition, and Metabolic Parameters", 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'The Effect of Pea Protein Supplementation on Muscle Hypertrophy and Metabolic Parameters in Young Adults Following an 8-week Resistance Training Program', 'orgStudyIdInfo': {'id': 'PProtRCT-FY2019-182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pea Protein', 'description': '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)', 'interventionNames': ['Dietary Supplement: Protein Isolate', 'Behavioral: Progressive Resistance Exercise Training (PRE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whey Protein', 'description': '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)', 'interventionNames': ['Dietary Supplement: Protein Isolate', 'Behavioral: Progressive Resistance Exercise Training (PRE)']}], 'interventions': [{'name': 'Protein Isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this arm will consume protein isolate (24g/sachet) twice daily for 8 weeks.', 'armGroupLabels': ['Pea Protein', 'Whey Protein']}, {'name': 'Progressive Resistance Exercise Training (PRE)', 'type': 'BEHAVIORAL', 'description': "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:\n\n1. Seated chest press\n2. Lat pulldown\n3. Military Press\n4. Seated row\n5. Bicep Curl\n6. Triceps Extension\n7. Leg Press\n8. Leg extension\n9. Leg Curl\n10. Heel Raise\n11. Abdominal curls\n12. Back extension At the first exercise session, each subject's 1-RM will be estimated for the exercises listed above", 'armGroupLabels': ['Pea Protein', 'Whey Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Woman's University Institute of Health Sciences Houston Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ingredion Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}