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

NCT04230824 | Completed

• 1 other identifier: 20-PHX-0001 Chronic
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Strength

  Change from baseline in strength by measuring 1 repetition maximum for leg press and bench press

  baseline, week 8

Secondary Outcomes (5)

• Muscle soreness

  baseline, week 8

• Recovery

  baseline, week 8

• Training Volume

  baseline, week 8

• Performance

  baseline, week 8

• Body Composition

  baseline, week 8

Study Arms (3)

Pre-workout plus and Protein recovery plus

ACTIVE COMPARATOR

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

Dietary Supplement: Pre-workout plus and Protein recovery plus; Other: 6-week resistance training program

Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Other: 6-week resistance training program

Control

NO INTERVENTION

This arm will receive no intervention

Interventions

Pre-workout plus and Protein recovery plus DIETARY_SUPPLEMENT

products consumed prior and after exercise

Pre-workout plus and Protein recovery plus

Placebo OTHER

placebo product consumed prior and after exercise

Placebo

6-week resistance training program 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; Pre-workout plus and Protein recovery plus

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanex: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 36407519 DERIVED

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: February 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)