Counteracting Age-related Loss of Skeletal Muscle Mass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Change in muscle cross sectional area
研究概览
简要总结
Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects.
Upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy Resistance Training (N=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50), Protein Collagen (N=40-50) and Carbohydrate (N=30-35). The individuals randomized into one of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to the supplement content.
Assessments will be performed at Baseline (before intervention start), and after 6 and 12 months of intervention and again at 18 months (after 6 months of follow up).
The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12 months of intervention.
The primary hypothesis is that by applying the intension-to-treat analysis, the Light Intensity Training group will increase quadriceps muscle cross sectional area just as much as the Heavy Resistance Training group. The two training groups will gain more muscle mass than the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate groups that will loose quadriceps muscle cross sectional areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, independently living
- •Age at least 65 years
排除标准
- •Subjects dependent on help/nursing etc.
- •Chronic medical diseases: Diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia.
- •Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
- •Implanted magnetic devices incompatible with MRi-scanning.
- •Weekly alcohol consumption > 21 units (1 unit equals 4g of ethanol) for men and > 14 for women.
- •Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics.
- •>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.
结局指标
主要结局
Change in muscle cross sectional area
时间窗: Baseline, 6, 12, and 18 months
MRi scans of quadriceps muscle cross sectional area. The primary time interval for assessment of the primary outcome measure is from Baseline to 12 months intervention. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey and 2) Protein Whey vs. Protein Collagen vs. Carbohydrate. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis. Assessments are performed at 6 months as well and at 18 months (after 6 months follow up). Changes in muscle cross sectional area will be evaluated over 6 months from Baseline to 6 months, from 6 to 12 months, and from 12 months to 18 months.
次要结局
- Change in quadriceps muscle isometric strength(Baseline, 6, 12 and 18 months)
- Change in quadriceps muscle isokinetic strength(Baseline, 6, 12 and 18 months)
- Change in leg extension muscle power(Baseline, 6, 12 and 18 months)
- Change in gut microbiota composition.(Baseline, 6 and 12 months (and 18 months on a subset of samples).)
- Change from baseline in muscle structure and signalling(Baseline and 12 months)
- Change in 30 s chair stand(Baseline, 6, 12 and 18 months)
- Change in whole body composition and bone mineral density(Baseline, 6, 12 and 18 months)
- Change in faecal metabolome.(Baseline, 6 and 12 months (and 18 months on a subset of samples).)
- Change in plasma metabolome.(Baseline, 6 and 12 months (and 18 months on a subset of samples).)
研究者
Lars Holm
Ph.D. M.S.
Bispebjerg Hospital