Acute Study on Muscle Soreness, Damage, and Performance

Pharmanex

Status: Completed

Conditions: Soreness, Muscle; Damage Muscle; Performance Enhancing Product Use

Treatments: Dietary Supplement: Pre-workout plus and protein recovery plus; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04230226

20-PHX-0001 Acute

Details and patient eligibility

About

The acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient supplement in a randomized, double-blind, placebo-controlled, crossover design. Participants will complete one enrollment visit, in which they will sign a consent form and complete a health history questionnaire. Participants will complete two interventions, with three visits each (6 visits total), in which a treatment beverage (pre/post supplement, or non-caloric placebo) will be consumed within 30 minutes prior to exercise and within 15 minutes post-exercise, in random order. Total time from enrollment to completion will be at least 14 days. Testing visits will be separated by a minimum of 7 days of rest to allow for recovery and washout, based on a half-life of ≤8 hours for all ingredients present in the supplement.

Enrollment: 32 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 (acute) or medications to prevent any further nutritional or drug related protection against exercise induced muscle damage
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Pre-workout and Post-workout Product

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Pre-workout plus and protein recovery plus

Study Placebo

Placebo Comparator group

Description:

non-caloric powder mixed with water consumed within 30 minutes prior to exercise and within 15 minutes post exercise

Treatment:

Other: Placebo