Effect of a Novel Blend of Plant Protein and Additional Ingredients on Resistance Training Adaptations (IOV)

Lindenwood University

Status: Completed

Conditions: Resistance Exercise

Treatments: Dietary Supplement: Carbohydrate Placebo; Dietary Supplement: Pea/Rice Protein Blend; Dietary Supplement: Novel Plant Protein Blend; Dietary Supplement: Whey Protein

Study type: Interventional

Funder types: Other

Identifiers

NCT06908811

IRB-22-67

Details and patient eligibility

About

This study seeks to compare the observed changes in resistance training adaptations (strength, performance, body composition, recovery, and lactate responses) after supplementation of isocaloric and isonitrogenous amounts of a novel plant protein formulation against changes observed in a pea/rice plant protein blend, whey protein, and a carbohydrate placebo in healthy resistance-trained men and women between the ages of 18-39.

Full description

This study seeks to compare the observed changes in resistance training adaptations (strength, performance, body composition, recovery, and lactate responses) after supplementation of isocaloric and isonitrogenous amounts of a novel plant protein formulation against changes observed in a pea/rice plant protein blend, whey protein, and a carbohydrate placebo in healthy resistance-trained men and women between the ages of 18-39.

Enrollment: 60 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Between the ages of 18-39 years
• Participants will be healthy and free of disease as determined by evaluation of a medical history
• All participants will be required to abstain from taking any additional forms of nutritional supplementation deemed to be ergogenic or that will impact resistance training adaptations (pre-workouts, creatine, beta-alanine, etc.) for four weeks prior to beginning this study and for the entire duration of the study.

Exclusion Criteria

• Those individuals less than 18 and greater than 39 years of age will be excluded.
• Participants who are determined to not be weight stable defined as pre-study and visit 1 body mass levels deviating by 3% or more.
• Any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease.
• Body mass index >29.9 kg/m2. Males with a body mass index greater than 29.9 kg/m2, but a body fat percentage less than 27.5% fat will be accepted into the study. Females with a body mass index greater than 29.9 kg/m2, but a body fat percentage less than 32.5% fat will be accepted into the study. The average body mass index for the entire study cohort will be less than 27.5 kg/m2. As such, an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 27.5 kg/m2
• Individuals who present with any previous injury or illness that would prevent them from appropriately completing all exercise lifts.
• Participants who are not able to fit onto the DEXA table will not be able to participate in the research due to size restrictions of the equipment. This typically includes individuals exceeding 400 pounds or those greater than 6'4".
• Those individuals with less than 3 months of structured resistance training, aerobic training, or team sport participation experience will be excluded from the study.
• Pregnant women, women trying to become pregnant, or nursing women. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Novel Plant Protein

Experimental group

Description:

Novel plant protein blend containing 30 grams of protein taken twice per day for 8 weeks

Treatment:

Dietary Supplement: Novel Plant Protein Blend

Pea/Rice Protein

Active Comparator group

Description:

Pea/Rice protein blend containing 30 grams of protein taken twice per day for 8 weeks

Treatment:

Dietary Supplement: Pea/Rice Protein Blend

Whey Protein

Active Comparator group

Description:

Whey protein blend containing 30 grams of protein taken twice per day for 8 weeks

Treatment:

Dietary Supplement: Whey Protein

Carbohydrate Placebo

Placebo Comparator group

Description:

Carbohydrate placebo (maltodextrin) taken twice per day for 8 weeks

Treatment:

Dietary Supplement: Carbohydrate Placebo