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临床试验/NCT03536871
NCT03536871已完成不适用

Exercise and Nutritional Supplementation for Aging and Sedentary Lifestyles

McMaster University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Body Composition

研究概览

简要总结

To understand the effects of a novel dietary supplement when used in conjunction with a healthy lifestyle exercise program and to define biomarkers that are specific to sarcopenia. A primary aim in the present study is to determine whether a relationship exists between positive changes in body composition through increases in lean mass and reductions in body fat following oral supplementation of naturally occurring food components in combination with exercise. The purpose of the present study is to examine the effects of a multi-nutrient supplement in combination with an endurance and resistance based exercise intervention in a cohort of older adult men with varying degrees of sarcopenia as compared to younger male controls (McMaster/CIHR/Exerkine project). A sub-purpose nested within the study is to provide serum and muscle samples for use in an aging/sarcopenia biomarker discovery study taken at pre-intervention for the young and older men (Buck Institute/Astellas project).

详细描述

The present study is a randomized double-blind placebo controlled repeated measures design, with sampling of the cohorts on multiple occasions. Upon obtaining informed consent participants will be randomized into one of six groups:

Healthy younger males - n=20; Healthy older males - placebo n=10, supplement n=10; Sarcopenic older males, placebo, n=20, supplement n=20;

Take home resistance training program The older adult male groups will be provided with a progressive resistance training program which will use exercise bands (Therabands®, Akron, Ohio) and consist of six upper body and six lower body exercises, which will be performed three times per week for 12 weeks without supervision at home. Each session will consist of active warm-up (5min), resistance training with elastic tubing (45min), and cool down (5min). Briefly, the resistance exercises will be performed using elastic tubing for chair squats, hip flexions, leg extensions, leg flexions, ankle dorsiflexion, wall push-ups, back rows, shoulder abductions, triceps extensions, and forearm flexions. Ankle plantar-flexions and abdominal curl-ups will be performed using body weight as resistance. Each participant will be given an exercise instruction booklet and a set of five elastic tubes offering different resistances. Prior to beginning the program trained staff will meet with participants and will teach them how to properly perform exercises in addition to determining the starting elastic tubing size. Furthermore, participants will perform one set of each exercise during weeks 1 and 2, two sets of each exercise during weeks 3 and 4, and three sets of lower body and two sets of upper body exercises during the remaining weeks. Participants will be instructed to move to the next larger tubing size when they can perform 12 repetitions with good exercise form during their last set. This progression will be monitored by the project staff mid way through the study over the phone.

Study products Study products will be provided by Infinit Nutrition Canada (Windsor, Ontario) to all older male subjects, however the young males will only act as baseline controls. The composition of the study products is displayed above in the general experimental design. Both products are similar in taste and appearance and provide an energetic value of ∼200 kcal per serving in a volume of 200 mL. Participants will be asked to consume 1 serving daily of the study product throughout the 12-wk intervention period. Participants will consume their serving at approximately the same time of day, but preferably before breakfast. Participants will be instructed to consume the supplement as a single bolus within 5-10 min. Subjects will also also be provided an omega-3 supplement (or placebo, if they are assigned to the placebo arm) and be instructed to consume 2 teaspoons at the same time as their nutritional supplement. Participants will be instructed to record product intake in a diary to check compliance. To maintain the double-blind nature of the experiment, the placebos, which contains microcrystalline cellulose or safflower oil, will be matched in size and appearance.

Three day weighed food record Participants will be asked to record everything that they consumed for 3 nonconsecutive days: 2 week-days and either a Saturday or a Sunday. On completion of the food record, it will be analyzed using a commercially available computerized database software (Nutribase version 11.5, Cybersoft Inc., Phoenix, AZ, USA). Food items will be aggregated into the following categories: fruit (e.g., fresh/frozen, tinned, juice), vegetables (e.g., fresh/frozen, canned), dairy products (e.g., milk, yoghurt, cheese), breads and cereals (e.g., bread, breakfast cereal, rice, pasta), meats and alternatives (e.g., red meat, poultry, fish, pork, processed meat, tofu, eggs, nuts) and extra foods (e.g., hamburger, pizza, meat pies, chocolate, cake, ice cream, jam, biscuits, crackers, crisps, alcohol).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The nutritional supplement will be delivered to a 3rd party contract research organization and the allocation will only be un-blinded after data lock.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Inactive younger men (< 1 hour of formal exercise/week) in the overweight BMI category (25 - 29.9 kg/m2).
  • Healthy older male participants will have a body mass index < 30 kg/m2, muscle mass index > 7.23 kg/m2, and a 4-meter walk test > 0.8 m/s.
  • Men in the older adult "sarcopenia" group will be individuals that have a body mass index < 30 kg/m2, a muscle mass index between 8.51-10.75 kg/m2, and a 4-meter walk test < 0.8m/s.

排除标准

  • Current smokers
  • On more than one anti-diabetic drug
  • Cardiovascular disease (myocardial infarction and/or hypertension requiring more than 2 medications)
  • Congestive heart failure
  • Renal disease (creatinine > 130)
  • Previous stroke
  • Hypertension requiring more than two-pharmacological agents
  • Active musculoskeletal injuries and/or severe osteoarthritis
  • Significant weight loss in the 3-month period prior to the study
  • Vegan diet
  • Dairy protein allergy
  • History of muscle and/or bone wasting diseases
  • Concurrent medications known to affect protein metabolism (i.e. corticosteroids, or prescription strength acne medications)
  • Inability to consent
  • Chronic obstructive pulmonary disease (FVC or FEV1 < 80% of age predicted mean value or requiring any medication other than a puffer as needed)
  • Concurrent supplementation with a dietary protein, calcium, l-leucine, creatine, CoQ10, alpha lipoic acid, n-3 PUFA, and conjugated linoleic acid.

结局指标

主要结局

Body Composition

时间窗: 12 weeks

Fat-Free and Fat Mass

Muscle Strength

时间窗: 12 weeks

Knee extension isometric strength and leg press

Functional Outcomes

时间窗: 12 weeks

6 Minute Walk Test

次要结局

  • Plasma lipids(12 weeks)
  • Mitochondrial Function(12 weeks)
  • Quality of Life assessment(12 weeks)
  • Inflammatory markers(12 weeks)
  • Glycemia measurements(12 weeks)
  • Muscle Fibre Size(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Tarnopolsky

Principal Investigator, Professor, Director of Neuromuscular and Neurometabolic Clinic

McMaster University

研究点 (2)

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