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临床试验/NCT06908811
NCT06908811已完成不适用

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

Lindenwood University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in Handgrip Strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Supplements were blinded, in labeled containers. Each supplement will be of a similar volume, texture, and flavor, and labeled in indistinguishable packaging to ensure blinding.

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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/m
  • •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/m
  • •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.

研究组 & 干预措施

Novel Plant Protein

Experimental

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

干预措施: Novel Plant Protein Blend (Dietary Supplement)

Pea/Rice Protein

Active Comparator

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

干预措施: Pea/Rice Protein Blend (Dietary Supplement)

Carbohydrate Placebo

Placebo Comparator

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

干预措施: Carbohydrate Placebo (Dietary Supplement)

Whey Protein

Active Comparator

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

干预措施: Whey Protein (Dietary Supplement)

结局指标

主要结局

Change in Handgrip Strength

时间窗: Week 0, Week 4, and Week 8

Maximal handgrip strength will be assessed using a calibrated hand dynamometer. Higher values indicate greater strength.

Change in 4-Compartment Lean Mass

时间窗: Week 0, Week 4, and Week 8

Lean mass will be assessed using a 4-compartment model, which includes measurements of body density, total body water, and bone mineral content.

Change in Perceptual Indicators of Training State

时间窗: Week 0, Week 4, and Week 8

Participants will rate their readiness to train, soreness, recovery, energy, and sleep quality using 100-mm visual analog scales. Each scale is anchored with contextually appropriate statements such as "Lowest Possible" and "Highest Possible."

Change in Profile of Mood States (POMS) Score

时间窗: Week 0, Week 4, and Week 8

Mood state will be assessed using the Profile of Mood States (POMS) questionnaire, a validated tool for measuring transient affective states. The POMS consists of six subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment), with a Total Mood Disturbance (TMD) score calculated by summing negative subscale scores and subtracting the Vigor score. Higher TMD scores indicate greater mood disturbance, while lower scores indicate improved mood state.

Change in Pressure to Pain Threshold

时间窗: Week 0, Week 4, and Week 8

Pressure pain threshold will be assessed using a digital algometer to determine the minimum pressure required to elicit pain. Higher scores indicate higher tolerance to pain.

Change in Isometric Mid-Thigh Pull Force

时间窗: Week 0, Week 4, and Week 8

Maximal force output will be assessed using an isometric mid-thigh pull on a force plate, measured in Newtons. Higher scores equal greater force production

Change in Hex Bar Deadlift One-Repetition Maximum (1RM)

时间窗: Week 0, Week 4, and Week 8

Maximal hex bar deadlift strength will be assessed using a standardized one-repetition maximum (1RM) test.

Change in Bench Press One-Repetition Maximum (1RM

时间窗: Week 0, Week 4, and Week 8

Maximal upper-body strength will be assessed using a standardized one-repetition maximum (1RM) bench press test.

Change in Isokinetic Peak Knee Extension Torque

时间窗: Week 0, Week 4, and Week 8

Peak torque of the quadriceps will be assessed using an isokinetic dynamometer. Higher values indicate greater knee extensor strength.

Performance in 5 Sets of Hex Bar Deadlift Protocol

时间窗: Week 0, Week 4, and Week 8

Strength endurance will be assessed using a hex bar deadlift protocol consisting of 3 sets of 10 repetitions at 70% 1RM and 2 sets to failure at 80% 1RM. Repetition count and total volume lifted will be recorded.

次要结局

  • Change in 4-Compartment Fat Mass(Week 0, Week 4, and Week 8)
  • Change in 4-Compartment Fat-Free Mass(Week 0, Week 4, and Week 8)
  • Change in 4-Compartment Percent Body Fat(Week 0, Week 4, and Week 8)
  • Change in Total, Extracellular, and Intracellular Body Water(Week 0, Week 4, and Week 8)
  • Change in Dry Fat-Free Mass(Week 0, Week 4, and Week 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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