NCT04814225已完成2 期
A Randomized, Triple-blind, Comparator Controlled, Parallel Clinical Trial to Study the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance in a Healthy, Sedentary Adult Population After the Initiation of a Resistance Training Program
Roquette Canada, LTD.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The difference in composite whole-body muscle strength
研究概览
简要总结
The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population.
详细描述
Whey, a by-product of cheese manufacturing, is commonly used as an ingredient in meat products, dairy products, baked goods, snacks, beverages, and infant formula. Its widespread use is due to its advantageous effects on health, economics, and high nutritional value by containing lactose, minerals, vitamins, and soluble proteins. Due to allergies, dietary restrictions and/or personal dietary choices there is a need for an alternative protein source(s), and plant-based protein options are in demand for these reasons. Roquette produces the NUTRALYS® Pea Protein family of ingredients, supplying the widest range of pea protein ingredients to the food industry suitable for use in a plethora of plant-based foods. Few studies have examined the equivalence between pea protein and whey on muscle performance in sedentary adults. The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population.
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)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males & females between 30 and <60 years of age, inclusive
- •Waist circumference < 102 cm (40 inches) in men and < 88 cm (35 inches) in women
- •Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- •Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Double-barrier method
- •Intrauterine devices
- •Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Participant having a sedentary lifestyle defined as not engaging in greater than 60 minutes of regular and structured moderate to vigorous exercise per week
- •Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
- •Agrees to follow and is able to complete the exercise guidelines for the duration of the study
- •Motivated to comply with exercise guidelines as assessed by the Self-Motivation Questionnaire at screening
- •Agrees to avoid vigorous exercise outside of regular routine for 48 hours prior to and after exercise challenge
- •Agrees to maintain their daily caloric intake
- •Willingness to complete questionnaires, records and diaries associated with the study and to complete all study assessments
- •Willing to refrain from taking NSAID for 24 hours prior to and 72 post study appointments
- •Provided voluntary, written, informed consent to participate in the study
- •Healthy as determined by medical history, laboratory results and electrocardiogram (ECG), as assessed by Qualified Investigator (QI)
排除标准
- •Women who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients. Adheres to a vegan diet
- •Engaged in regular and structured resistance training (≥2x times per week) as assessed by the QI
- •Currently experiencing any medical condition that interferes with the ability to undergo physical strength testing during the study and/or ability to complete exercise guidelines as assessed by the QI
- •Metal implants that may affect the DEXA scan results as assessed on case-by-case basis by the QI
- •Participants who have followed a specific diet (e.g. ketogenic, paleo, etc.) or have had a change of diet within 30 days of baseline as assessed by the QI
- •Current regular use of a protein supplement unless willing to washout (Section 7.3.2)
- •Current use of over-the-counter medications, dietary supplements, foods/drinks for muscle building or function unless willing to washout (Section 7.3.2)
- •Current use of prescribed medications for muscle building or function (see Section 7.3.1)
- •Current use of prescribed steroidal anti-inflammatory medications (see Section 7.3.1), or anti-inflammatory over-the-counter medications or supplements (see Section 7.3.2) unless willing to washout
- •Significant cardiovascular event or revascularization in the past 6 months. Participants with history of cardiovascular event or revascularization will be assessed case by case by the QI. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis.
- •History of kidney stones will be assessed by the QI on a case-by-case basis
- •Self-reported confirmation of a HIV-, Hepatitis B- or C-positive diagnosis, autoimmune disease or those that are immune compromised
- •Self-reported confirmation of blood/bleeding disorders
- •Alcohol intake >2 standard drinks per day
- •Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study appointment as assessed by the QI
- •Participation in other pharmaceutical, weight loss/diet, exercise intervention or clinical research studies 30 days prior to enrollment as assessed by the QI
- •Individuals who are unable to give informed consent
- •Any other condition, chronic disease or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
结局指标
主要结局
The difference in composite whole-body muscle strength
时间窗: From baseline to day 84
The difference in composite whole-body muscle strength, as assessed by the sum of handgrip, elbow flexion and extension and knee flexion and extension strength from baseline to day 84 between IPs 1, 2, 3 and comparator.
次要结局
- The difference in change in weight(From baseline to day 84)
- The difference in change in android/gynoid fat ratio(From baseline to day 84)
- The difference in change in product tolerability(From baseline to days 28, 56 and 84)
- The difference in change in upper body strength(From baseline to days 28, 56 and 84)
- The difference in change in fat mass (% or g)(From baseline to day 84)
- The difference in change in handgrip strength(From baseline to days 28, 56 and 84)
- The difference in change in isometric leg strength(From baseline to days 28, 56 and 84)
- The difference in change in waist circumference(From baseline to day 84)
- The difference in change in muscle mass (% or g)(From baseline to day 84)
- The difference in change in quality of life(From baseline to days 28, 56 and 84)
- The difference in change in blood CRP concentrations(From baseline to days 28, 56 and 84)
- The difference in change in immune function(From screening to day 84)
- The difference in product perception(At day 84)
- The difference in change in endurance performance(From baseline to days 28, 56 and 84)
研究者
研究点 (2)
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