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临床试验/NCT03600311
NCT03600311已完成不适用

Using Resistance Exercise and Protein Consumption to Protect Bone Health During Weight Loss

University of Nebraska Lincoln2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年8月31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
17
试验地点
2
主要终点
Change in Serum [CTX] (ng/mL)

研究概览

简要总结

The purpose of this study is to determine if post-exercise protein supplementation can rescue the anabolic response of muscle and bone to resistance exercise during caloric restriction.

详细描述

  1. Preliminary Testing Prior to the study start, participants will be weighed and body composition will be determined using bioimpedance analysis. Then participants will undergo a 5RM barbell back squat exercise testing procedure.
  2. Randomization

Participants will proceed through each of the following conditions lasting 3 days:

CON: Participants will be in energy balance and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise.

CR+C: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g maltodextrin post-exercise.

CR+P: Participants will be restricted to 15 kcal/kg FFM/day and consume 1.2 g protein/kg BW/day. Participants will be provided 30 g whey protein post-exercise. 3. Diet Prescription Dietary energy intake will be controlled using clinical products, maltodextrin and whey protein isolate to meet target energy intakes. Participants will receive calcium and Vitamin D supplementation throughout the study. 4. Exercise Prescription Participants will perform one bout of 5 sets of 5 repetitions of barbell back squat exercise on the morning of Day 3 each condition. Additional exercise and intense physical activity will be prohibited. 5. Assessments Body weight and composition (DXA + BIA), fasting blood draws for assessment of metabolic and anabolic hormones and questionnaires will be conducted before and after each condition. A 24-hour serial blood draw procedure will be conducted following each workout session on each Day 3. 6. Washout Once a participant completes a study condition, participants will continue to take daily body weights at home for up to one week. Then participants will be required to wait one more week before completing their next condition during which they will resume regular diet and physical activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Weigh at least 110 lbs
  • Weight-Stable (2.5 kg) within the past six months
  • Height-Stable (< 0.25 inches) within the past year
  • 3 years of resistance training experience
  • Tested Inclusion Criteria:
  • <20% body fat (men) or <30% body fat (women)

排除标准

  • Lactose intolerant
  • Pregnancy
  • Taking interfering medications such as steroids, thyroid or growth hormones

研究组 & 干预措施

Energy Balance

Placebo Comparator

Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

干预措施: Calcium and Vitamin D (Dietary Supplement)

Energy Balance

Placebo Comparator

Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

干预措施: Energy Balance (Other)

Energy Balance

Placebo Comparator

Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

干预措施: Post-Exercise Carbohydrate (Dietary Supplement)

Caloric Restriction and CHO Supp

Active Comparator

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

干预措施: Caloric Restriction (Other)

Caloric Restriction and CHO Supp

Active Comparator

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

干预措施: Post-Exercise Carbohydrate (Dietary Supplement)

Caloric Restriction and PRO Supp

Experimental

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of whey protein following exercise.

干预措施: Caloric Restriction (Other)

Caloric Restriction and PRO Supp

Experimental

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of whey protein following exercise.

干预措施: Post-Exercise Protein (Dietary Supplement)

Caloric Restriction and PRO Supp

Experimental

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of whey protein following exercise.

干预措施: Calcium and Vitamin D (Dietary Supplement)

Caloric Restriction and CHO Supp

Active Comparator

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

干预措施: Calcium and Vitamin D (Dietary Supplement)

结局指标

主要结局

Change in Serum [CTX] (ng/mL)

时间窗: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

Measured via ELISA

Change in Serum [P1NP] (pg/mL)

时间窗: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

Measured via ELISA

Change in Serum [IGF-1] (ng/mL)

时间窗: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

Measured via ELISA

Change in Serum [IGFBP-3] (ng/mL)

时间窗: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

Measured via ELISA

Change in Serum [GH] (pg/mL)

时间窗: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

Measured via ELISA

Change in Serum [Sclerostin] (pmol/L)

时间窗: Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

Measured via ELISA

次要结局

  • Change in Body Weight (kg)(Baseline and Day 4)
  • Change in Perceived Hunger (mm or %)(Baseline and Day 4)
  • Change in Body Fat Percentage (%)(Baseline and Day 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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