Effects of Pea Proteins on Muscle Damage and Recovery

NCT05657314 | Completed

• 1 other identifier: BIOHM-1221
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-blind, randomized, placebo-controlled, crossover clinical trial of N=40 recreationally active men to be recruited a single investigational center in Ohio (i.e., The Center for Applied Health Sciences). Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks. Outcome variables include plasma amino acids, muscle damage, muscle recovery, and GI tolerance.

Conditions

Pea Proteins; Muscle Damage; Amino Acid Change

Outcome Measures

Primary Outcomes (6)

• Plasma amino acids

  Plasma amino acid responses before and 30, 60, 90, 120, 180 min post-ingestion of the test product.

  Change from baseline to 4 weeks.

• Lactate dehydrogenase (LDH)

  Concentration of LDH in plasma.

  Change from baseline to 24 hours after acute exercise.

• Creatine kinase (CK)

  Concentration of CK in plasma.

  Change from baseline to 24 hours after acute exercise.

• Myoglobin

  Concentration of myoglobin in plasma.

  Change from baseline to 24 hours after acute exercise.

• Blood Urea Nitrogen (BUN)

  Concentration of BUN in plasma.

  Change from baseline to 24 hours after acute exercise.

• Mid thigh circumference

  Mid thigh circumference as measured using a tape measure.

  Change from baseline to 24 hours after acute exercise.

Secondary Outcomes (4)

• Gastro Intestinal Bloating

  Change from baseline to 4 weeks.

• Gastro Intestinal Flatulence

  Change from baseline to 4 weeks.

• Fatigue

  Change from baseline to 4 weeks.

• Muscle Soreness

  Change from baseline to 24 hours after acute exercise.

Study Arms (2)

Comparator

ACTIVE COMPARATOR

15 grams of pea protein dissolved in 12 ounces of water.

Dietary Supplement: Active Comparator

Active

EXPERIMENTAL

15 grams of pea protein + probiotic blend (1 billion CFU/capsule - blend of Lactobacillus rhamnosus, Lactobacillus acidophilus, Saccharomyces boulardii, and Bifidobacterium breve) dissolved in 12 ounces of water.

Dietary Supplement: Active Comparator

Interventions

Active Comparator DIETARY_SUPPLEMENT

Consists of 15 grams of pea protein

Active; Comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide voluntary signed and dated informed consent.
• Be in good health as determined by medical history and routine blood chemistries.
• Age between the ages of 18 and 55 (inclusive).
• Body Mass Index of 18.5-29.9 (inclusive).
• Subject agrees to maintain existing dietary patterns throughout the study period apart from ingesting the provided treatment beverage.
• Subject is willing and able to comply with the study and supplement protocol.
• Subject agrees to abstain from alcohol, coffee, and caffeinated beverages 24 hours prior to testing on all study visits.
• Subject agrees to abstain from strenuous exercise 72 hours prior to testing on all study visits.
• Body weight of at least 120 pounds.
• Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
• Normal seated, resting heart rate (\<90 per minute).
• Willing to duplicate their previous 24-hour and fast for 8 hours prior each study visit.

You may not qualify if:

• Individuals who have been diagnosed with liver, renal, cardiovascular, or other metabolic disease.
• Use of any dietary supplements which may confound the study or its endpoints, including creatine, BCAA, HMB, betaine, beta-alanine, etc.
• Use of any prescription medications (particularly antibiotics and/or anti-inflammatories), or probiotics within the past 2 months which may confound the study or its endpoints.
• Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
• Smokers.
• Clinically significant abnormal laboratory results at screening.
• Known sensitivity to any ingredient in the test formulations as listed in the Nutrition Facts label.
• Individuals who are cognitively impaired and/or who are unable to give informed consent.
• Individuals with diabetes, asthma, chronic inflammatory conditions (e.g., rheumatoid arthritis, colitis, IBS/IBD, gout or fibromyalgia, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
• Individuals with excessive caffeine intake (600mg/day).
• Subjects who take medication which may adversely affect the measured outcomes (i.e., testosterone or other anabolic steroids, corticosteroids or testosterone replacement therapy (ingestion, injection, or transdermal), diuretics, etc.)
• History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Prior gastrointestinal bypass surgery (i.e., Lapband, etc.).
• Women

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead
• Biohm Health, LLC: collaborator

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks.

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 20, 2022
• Study Start: January 6, 2022
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

US (1)