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临床试验/NCT05922462
NCT05922462招募中不适用

Effects of Increased Greek Yogurt Consumption on Circulating Markers of Bone Metabolism and Inflammation in Youth and Young Adult Athletes

Brock University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Osteoprotegerin (OPG)

研究概览

简要总结

Physical activity and dairy consumption during growth and development are each known to improve peak bone mass in young adults. Peak bone mass, the maximum amount of bone a person will have in their lifetime, is typically reached in the early 20's in females and late 20's in males. However, evidence suggests that young people do not consume enough dairy to maximize their bone mass. The resulting effect in peak bone mass can be troublesome, particularly for athletes, such as volleyball players. This study aims to determine whether increased dairy consumption combined with training can have an additive effect on the physiology of young competitive athletes. Specifically, we will examine whether Greek yogurt consumption will lead to beneficial changes in bone metabolism and inflammation, in adolescent and young adult, male and female athletes, similar to those observed with whey protein supplementation. Many athletes choose exclusively protein supplementation and miss out on other nutrients vital for healthy growth and development. By examining the benefits of Greek yogurt across different athlete age groups and sexes, this work will help reshape the attitudes, beliefs, and behaviours surrounding diet of young athletes.

详细描述

Purpose: This study will investigate the effect of chronic high-impact exercise training and GY consumption on bone metabolism and inflammation compared with isonitrogenous/isocaloric whey protein (WP) supplementation (a common practice by athletes) in youth and young adult athletes.

Participants: A total of 40 varsity athletes (aged 17-22 years; 20 males, 20 females) will be recruited in year one, and 40 club athletes (aged 15-16 years; 20 males, 20 females) will be recruited in year two. Participants will be recruited from the varsity teams at Brock and club teams in the Niagara area (one male and one female team from each age group). All participants (and the parents/guardians of club athletes) will provide written informed consent in order to be included in the study. Potential participants will complete an online health screening questionnaire to document general health and individual and family health history. It will also be used to record information on medication use and for female participants to report menstrual history and status, as well as the use and type of oral contraceptives (brand and hormone). Athletes will be excluded from the study if they are injured and unable to participate in practices, have an allergy to dairy foods/dairy protein or have been diagnosed with lactose intolerance.

Athletes from each team will be randomly assigned to either the GY intervention group or the WP comparison group. Thus, eight treatment groups (n = 10 athletes per group):

  • GY x Female Varsity
  • GY x Male Varsity
  • GY x Female Club
  • GY x Male Club
  • WP x Female Varsity
  • WP x Male Varsity
  • WP x Female Club
  • WP x Male Club

Study Design and Procedures: The study will follow a randomized controlled parallel design over a two-year period. At the beginning of their training season, varsity (year one) and club athletes (year two) will be invited to participate in this 24-week study, consisting of an 8-week control condition (September to November) and a 16-week intervention condition (November to March).

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
None

入排标准

年龄范围
15 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Competitive youth or varsity athletes

排除标准

  • Presence of injury
  • Inability to participate in practices
  • Allergy to dairy foods/dairy protein or
  • Diagnosis with lactose intolerance

结局指标

主要结局

Osteoprotegerin (OPG)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting serum levels of bone formation regulator OPG (pg/ml)

Sclerostin

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting serum levels of bone resorption regulator sclerostin (pg/ml)

Amino-terminal propeptide of type I collagen (P1NP)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting serum levels of bone formation marker P1NP (pg/ml)

Interleukin-10 (IL10)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting plasma levels of the anti-inflammatory cytokine IL10 (pg/ml)

C-telopeptides of type I collagen (CTX)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting serum levels of bone resorption marker CTX (ng/ml)

Receptor activator of nuclear factor kappa-Β ligand (RANKL)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting serum levels of bone resorption regulator RANKL (pg/ml)

Interleukin-6 (IL6)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting plasma levels of the inflammatory cytokine IL6 (pg/ml)

Tumour necrosis factor-alpha (TNFα)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting plasma levels of the pro-inflammatory cytokine TNFα (pg/ml)

Osteocalcin

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting serum levels of the bone remodelling marker osteocalcin (ng/ml)

Parathyroid hormone (PTH)

时间窗: Completion of intervention period (week 24)

Morning, fasted, resting serum levels of bone related hormone PTH (pmol/L)

次要结局

  • Dietary intake (kcal/day)(Completion of intervention period (week 24))
  • Nutrition knowledge(Completion of intervention period (week 24))
  • Testosterone(Completion of intervention period (week 24))
  • Lean mass(Completion of intervention period (week 24))
  • Bone Properties(Completion of intervention period (week 24))
  • Body mass(Completion of intervention period (week 24))
  • Insulin-like growth factor 1 (IGF1)(Completion of intervention period (week 24))
  • Estrogen(Completion of intervention period (week 24))
  • Fat mass(Completion of intervention period (week 24))
  • Body fat percentage(Completion of intervention period (week 24))
  • Height(Completion of intervention period (week 24))
  • Energy expenditure (kcal/week)(Completion of intervention period (week 24))
  • Training volume (hours/week)(Completion of intervention period (week 24))

研究者

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

Panagiota Klentrou

Professor

Brock University

研究点 (2)

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