Chronic Study on Body Composition, Training, Performance, and Recovery

NCT ID: NCT04230824

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-01-01

Brief Summary

The chronic phase of the study will evaluate the effects of pre-exercise and post-exercise ingestion of a multi-ingredient supplement on adaptations to a 6-week exercise program consisting of both resistance training and high intensity aerobic exercise, using a randomized, double-blind, placebo-controlled design. Participants will complete an enrollment/familiarization visit, a baseline testing session, followed by a 6-week supervised exercise intervention, and post-testing session identical to baseline testing. Participants will be randomized during the baseline session to groups receiving either 1) Active Treatment (pre-post supplementation), 2) placebo (noncaloric beverage), or 3) control, not participating in exercise or consuming a treatment. During the supervised 6-week resistance training program, participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week). Thirty-minutes prior to each training session, and within 15 minutes post-exercise, participants will consume their randomly assigned treatment beverage. Body composition, blood markers of muscle damage/recovery, strength, and performance tests will be measured before (baseline) and after training (Post) to evaluate the effects of supplementation. All data collection will be conducted by the Principal Investigator and Research Assistants. All subjects will report to the Applied Physiology Laboratory and Human Performance Center in Fetzer Hall for all testing and training sessions, which will span approximately 8 weeks.

Conditions

Damage Muscle; Body Weight Changes; Performance Enhancing Product Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Pre-workout plus and Protein recovery plus

Pre-workout plus: a blend of caffeine, choline bitartrate, carbohydrate, HMB, vitamin D3 mixed with water and consumed within 30 minutes prior to exercise

Protein recovery plus: a blend of whey protein, caseinate, carbohydrate, vitamin C, alpha-tocopherol, vitamin D3, glucosamine mixed with water and consumed 15 minutes post exercise

Group Type: ACTIVE_COMPARATOR

Pre-workout plus and Protein recovery plus

Intervention Type: DIETARY_SUPPLEMENT

products consumed prior and after exercise

6-week resistance training program

Intervention Type: OTHER

participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week)

Placebo

Non-caloric powder mixed with water and consumed within 30 minutes prior to exercise and within 15 minutes after exercise

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo product consumed prior and after exercise

6-week resistance training program

Intervention Type: OTHER

participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week)

Control

This arm will receive no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-workout plus and Protein recovery plus

products consumed prior and after exercise

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo product consumed prior and after exercise

Intervention Type: OTHER

6-week resistance training program

participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant is an adult between the ages of 25-50 years
• Participant has a recorded BMI of 20-35 kg/m2
• Participant exercises less than 3 hours per week for at least 8 weeks preceding the study
• Participant has provided written and dated informed consent to participate in the study
• Participant is willing to and able to comply with the protocol
• Participant is apparently healthy and no reported metabolic disorders, heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire
• Participant agrees to maintain current diet and exercise routine during the study
• Participant agrees to refrain from taking any anti-inflammatory supplement 48 hours prior to exercise or for exercise related pain or medications to prevent any further nutritional or drug related protection against exercise induced muscle damage
• Participant agrees to wear an accelerometer to track activity during entire study
• Participant has a resting (seated for 5 minutes) blood pressure of systolic pressure between 140-90 mmHg and a diastolic pressure between 90-50 mmHg

Exclusion Criteria

• Participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement Participant is using, or has consistently used one of the following dietary supplements within 12 weeks prior to enrollment: Beta-alanine, Creatine, HMB, Carnosine, Vitamin D
• Participant has consistently consumed whey protein/plant protein and/or 1,000 mg of fish oil within the previous 4 weeks prior to enrollment
• Participant has gained or lost ≥ 8 lbs in the previous month
• Participant has a known allergy or sensitivity to the placebo or active ingredients
• Participant has used tobacco more than three days per week (on average) in the previous 6 months, or refuses to abstain from all tobacco use for the duration of the study
• Participant is pregnant or planning to become pregnant
• Participant has any musculoskeletal condition prohibiting them from participation

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Pharmanex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbie Smith-Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

Cabre HE, Gordon AN, Patterson ND, Smith-Ryan AE. Evaluation of pre-workout and recovery formulations on body composition and performance after a 6-week high-intensity training program. Front Nutr. 2022 Nov 2;9:1016310. doi: 10.3389/fnut.2022.1016310. eCollection 2022.

Reference Type: DERIVED

PMID: 36407519 (View on PubMed)

Other Identifiers

20-PHX-0001 Chronic

Identifier Type: -

Identifier Source: org_study_id