Inflammation Clinical Trial
Official title:
Effects of Increased Greek Yogurt Consumption on Circulating Markers of Bone Metabolism and Inflammation in Youth and Young Adult Athletes
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2026 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 22 Years |
Eligibility | Inclusion Criteria: - Competitive youth or varsity athletes Exclusion Criteria: - Presence of injury - Inability to participate in practices - Allergy to dairy foods/dairy protein or - Diagnosis with lactose intolerance |
Country | Name | City | State |
---|---|---|---|
Canada | Brock University | St. Catharines | Ontario |
Lead Sponsor | Collaborator |
---|---|
Brock University | York University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Osteocalcin | Morning, fasted, resting serum levels of the bone remodelling marker osteocalcin (ng/ml) | Baseline (week 0) | |
Primary | Osteocalcin | Morning, fasted, resting serum levels of the bone remodelling marker osteocalcin (ng/ml) | End of control period and pre-intervention (week 8) | |
Primary | Osteocalcin | Morning, fasted, resting serum levels of the bone remodelling marker osteocalcin (ng/ml) | Middle of intervention period (week 16) | |
Primary | Osteocalcin | Morning, fasted, resting serum levels of the bone remodelling marker osteocalcin (ng/ml) | Completion of intervention period (week 24) | |
Primary | Amino-terminal propeptide of type I collagen (P1NP) | Morning, fasted, resting serum levels of bone formation marker P1NP (pg/ml) | Baseline (week 0) | |
Primary | Amino-terminal propeptide of type I collagen (P1NP) | Morning, fasted, resting serum levels of bone formation marker P1NP (pg/ml) | End of control period and pre-intervention (week 8) | |
Primary | Amino-terminal propeptide of type I collagen (P1NP) | Morning, fasted, resting serum levels of bone formation marker P1NP (pg/ml) | Middle of intervention period (week 16) | |
Primary | Amino-terminal propeptide of type I collagen (P1NP) | Morning, fasted, resting serum levels of bone formation marker P1NP (pg/ml) | Completion of intervention period (week 24) | |
Primary | Osteoprotegerin (OPG) | Morning, fasted, resting serum levels of bone formation regulator OPG (pg/ml) | Baseline (week 0) | |
Primary | Osteoprotegerin (OPG) | Morning, fasted, resting serum levels of bone formation regulator OPG (pg/ml) | End of control period and pre-intervention (week 8) | |
Primary | Osteoprotegerin (OPG) | Morning, fasted, resting serum levels of bone formation regulator OPG (pg/ml) | Middle of intervention period (week 16) | |
Primary | Osteoprotegerin (OPG) | Morning, fasted, resting serum levels of bone formation regulator OPG (pg/ml) | Completion of intervention period (week 24) | |
Primary | C-telopeptides of type I collagen (CTX) | Morning, fasted, resting serum levels of bone resorption marker CTX (ng/ml) | Baseline (week 0) | |
Primary | C-telopeptides of type I collagen (CTX) | Morning, fasted, resting serum levels of bone resorption marker CTX (ng/ml) | End of control period and pre-intervention (week 8) | |
Primary | C-telopeptides of type I collagen (CTX) | Morning, fasted, resting serum levels of bone resorption marker CTX (ng/ml) | Middle of intervention period (week 16) | |
Primary | C-telopeptides of type I collagen (CTX) | Morning, fasted, resting serum levels of bone resorption marker CTX (ng/ml) | Completion of intervention period (week 24) | |
Primary | Sclerostin | Morning, fasted, resting serum levels of bone resorption regulator sclerostin (pg/ml) | Baseline (week 0) | |
Primary | Sclerostin | Morning, fasted, resting serum levels of bone resorption regulator sclerostin (pg/ml) | End of control period and pre-intervention (week 8) | |
Primary | Sclerostin | Morning, fasted, resting serum levels of bone resorption regulator sclerostin (pg/ml) | Middle of intervention period (week 16) | |
Primary | Sclerostin | Morning, fasted, resting serum levels of bone resorption regulator sclerostin (pg/ml) | Completion of intervention period (week 24) | |
Primary | Receptor activator of nuclear factor kappa-? ligand (RANKL) | Morning, fasted, resting serum levels of bone resorption regulator RANKL (pg/ml) | Baseline (week 0) | |
Primary | Receptor activator of nuclear factor kappa-? ligand (RANKL) | Morning, fasted, resting serum levels of bone resorption regulator RANKL (pg/ml) | End of control period and pre-intervention (week 8) | |
Primary | Receptor activator of nuclear factor kappa-? ligand (RANKL) | Morning, fasted, resting serum levels of bone resorption regulator RANKL (pg/ml) | Middle of intervention period (week 16) | |
Primary | Receptor activator of nuclear factor kappa-? ligand (RANKL) | Morning, fasted, resting serum levels of bone resorption regulator RANKL (pg/ml) | Completion of intervention period (week 24) | |
Primary | Parathyroid hormone (PTH) | Morning, fasted, resting serum levels of bone related hormone PTH (pmol/L) | Baseline (week 0) | |
Primary | Parathyroid hormone (PTH) | Morning, fasted, resting serum levels of bone related hormone PTH (pmol/L) | End of control period and pre-intervention (week 8) | |
Primary | Parathyroid hormone (PTH) | Morning, fasted, resting serum levels of bone related hormone PTH (pmol/L) | Middle of intervention period (week 16) | |
Primary | Parathyroid hormone (PTH) | Morning, fasted, resting serum levels of bone related hormone PTH (pmol/L) | Completion of intervention period (week 24) | |
Primary | Interleukin-6 (IL6) | Morning, fasted, resting plasma levels of the inflammatory cytokine IL6 (pg/ml) | Baseline (week 0) | |
Primary | Interleukin-6 (IL6) | Morning, fasted, resting plasma levels of the inflammatory cytokine IL6 (pg/ml) | End of control period and pre-intervention (week 8) | |
Primary | Interleukin-6 (IL6) | Morning, fasted, resting plasma levels of the inflammatory cytokine IL6 (pg/ml) | Middle of intervention period (week 16) | |
Primary | Interleukin-6 (IL6) | Morning, fasted, resting plasma levels of the inflammatory cytokine IL6 (pg/ml) | Completion of intervention period (week 24) | |
Primary | Interleukin-10 (IL10) | Morning, fasted, resting plasma levels of the anti-inflammatory cytokine IL10 (pg/ml) | Baseline (week 0) | |
Primary | Interleukin-10 (IL10) | Morning, fasted, resting plasma levels of the anti-inflammatory cytokine IL10 (pg/ml) | End of control period and pre-intervention (week 8) | |
Primary | Interleukin-10 (IL10) | Morning, fasted, resting plasma levels of the anti-inflammatory cytokine IL10 (pg/ml) | Middle of intervention period (week 16) | |
Primary | Interleukin-10 (IL10) | Morning, fasted, resting plasma levels of the anti-inflammatory cytokine IL10 (pg/ml) | Completion of intervention period (week 24) | |
Primary | Tumour necrosis factor-alpha (TNFa) | Morning, fasted, resting plasma levels of the pro-inflammatory cytokine TNFa (pg/ml) | Baseline (week 0) | |
Primary | Tumour necrosis factor-alpha (TNFa) | Morning, fasted, resting plasma levels of the pro-inflammatory cytokine TNFa (pg/ml) | End of control period and pre-intervention (week 8) | |
Primary | Tumour necrosis factor-alpha (TNFa) | Morning, fasted, resting plasma levels of the pro-inflammatory cytokine TNFa (pg/ml) | Middle of intervention period (week 16) | |
Primary | Tumour necrosis factor-alpha (TNFa) | Morning, fasted, resting plasma levels of the pro-inflammatory cytokine TNFa (pg/ml) | Completion of intervention period (week 24) | |
Secondary | Insulin-like growth factor 1 (IGF1) | Morning, fasted, resting plasma levels of IGF1 (ng/ml) | Baseline (week 0) | |
Secondary | Insulin-like growth factor 1 (IGF1) | Morning, fasted, resting plasma levels of IGF1 (ng/ml) | End of control period and pre-intervention (week 8) | |
Secondary | Insulin-like growth factor 1 (IGF1) | Morning, fasted, resting plasma levels of IGF1 (ng/ml) | Middle of intervention period (week 16) | |
Secondary | Insulin-like growth factor 1 (IGF1) | Morning, fasted, resting plasma levels of IGF1 (ng/ml) | Completion of intervention period (week 24) | |
Secondary | Testosterone | Morning, fasted, resting plasma levels of testosterone (pg/ml) will be measured in male athletes | Baseline (week 0) | |
Secondary | Testosterone | Morning, fasted, resting plasma levels of testosterone (pg/ml) will be measured in male athletes | End of control period and pre-intervention (week 8) | |
Secondary | Testosterone | Morning, fasted, resting plasma levels of testosterone (pg/ml) will be measured in male athletes | Middle of intervention period (week 16) | |
Secondary | Testosterone | Morning, fasted, resting plasma levels of testosterone (pg/ml) will be measured in male athletes | Completion of intervention period (week 24) | |
Secondary | Estrogen | Morning, fasted, resting plasma levels of estrogen (pg/ml) will be measured in female athletes | Baseline (week 0) | |
Secondary | Estrogen | Morning, fasted, resting plasma levels of estrogen (pg/ml) will be measured in female athletes | End of control period and pre-intervention (week 8) | |
Secondary | Estrogen | Morning, fasted, resting plasma levels of estrogen (pg/ml) will be measured in female athletes | Middle of intervention period (week 16) | |
Secondary | Estrogen | Morning, fasted, resting plasma levels of estrogen (pg/ml) will be measured in female athletes | Completion of intervention period (week 24) | |
Secondary | Body mass | Body mass (kg) will be measured using Bioelectrical Impedance | Baseline (week 0) | |
Secondary | Body mass | Body mass (kg) will be measured using Bioelectrical Impedance | End of control period and pre-intervention (week 8) | |
Secondary | Body mass | Body mass (kg) will be measured using Bioelectrical Impedance | Middle of intervention period (week 16) | |
Secondary | Body mass | Body mass (kg) will be measured using Bioelectrical Impedance | Completion of intervention period (week 24) | |
Secondary | Fat mass | Fat mass (kg) will be measured using Bioelectrical Impedance | Baseline (week 0) | |
Secondary | Fat mass | Fat mass (kg) will be measured using Bioelectrical Impedance | End of control period and pre-intervention (week 8) | |
Secondary | Fat mass | Fat mass (kg) will be measured using Bioelectrical Impedance | Middle of intervention period (week 16) | |
Secondary | Fat mass | Fat mass (kg) will be measured using Bioelectrical Impedance | Completion of intervention period (week 24) | |
Secondary | Lean mass | Lean mass (kg) will be measured using Bioelectrical Impedance | Baseline (week 0) | |
Secondary | Lean mass | Lean mass (kg) will be measured using Bioelectrical Impedance | End of control period and pre-intervention (week 8) | |
Secondary | Lean mass | Lean mass (kg) will be measured using Bioelectrical Impedance | Middle of intervention period (week 16) | |
Secondary | Lean mass | Lean mass (kg) will be measured using Bioelectrical Impedance | Completion of intervention period (week 24) | |
Secondary | Body fat percentage | Body fat percentage (%) will be measured using Bioelectrical Impedance Analysis | Baseline (week 0) | |
Secondary | Body fat percentage | Body fat percentage (%) will be measured using Bioelectrical Impedance Analysis | End of control period and pre-intervention (week 8) | |
Secondary | Body fat percentage | Body fat percentage (%) will be measured using Bioelectrical Impedance Analysis | Middle of intervention period (week 16) | |
Secondary | Body fat percentage | Body fat percentage (%) will be measured using Bioelectrical Impedance Analysis | Completion of intervention period (week 24) | |
Secondary | Height | Height (cm) will be measured using a stadiometer | Baseline (week 0) | |
Secondary | Height | Height (cm) will be measured using a stadiometer | End of control period and pre-intervention (week 8) | |
Secondary | Height | Height (cm) will be measured using a stadiometer | Middle of intervention period (week 16) | |
Secondary | Height | Height (cm) will be measured using a stadiometer | Completion of intervention period (week 24) | |
Secondary | Bone Properties | Bone speed of sound (m/s) will be measured with transaxial quantitative ultrasound | Baseline (week 0) | |
Secondary | Bone Properties | Bone speed of sound (m/s) will be measured with transaxial quantitative ultrasound | End of control period and pre-intervention (week 8) | |
Secondary | Bone Properties | Bone speed of sound (m/s) will be measured with transaxial quantitative ultrasound | Middle of intervention period (week 16) | |
Secondary | Bone Properties | Bone speed of sound (m/s) will be measured with transaxial quantitative ultrasound | Completion of intervention period (week 24) | |
Secondary | Dietary intake (kcal/day) | Participants' dietary intake, including energy intake, as well as macronutrient, micronutrient, vitamin, and supplement intakes will be recorded using the Keenoa food application. Using the same application, participants will be asked to log their GY or WP intake in order to monitor adherence. | Baseline (week 0) | |
Secondary | Dietary intake (kcal/day) | Participants' dietary intake, including energy intake, as well as macronutrient, micronutrient, vitamin, and supplement intakes will be recorded using the Keenoa food application. Using the same application, participants will be asked to log their GY or WP intake in order to monitor adherence. | End of control period and pre-intervention (week 8) | |
Secondary | Dietary intake (kcal/day) | Participants' dietary intake, including energy intake, as well as macronutrient, micronutrient, vitamin, and supplement intakes will be recorded using the Keenoa food application. Using the same application, participants will be asked to log their GY or WP intake in order to monitor adherence. | Middle of intervention period (week 16) | |
Secondary | Dietary intake (kcal/day) | Participants' dietary intake, including energy intake, as well as macronutrient, micronutrient, vitamin, and supplement intakes will be recorded using the Keenoa food application. Using the same application, participants will be asked to log their GY or WP intake in order to monitor adherence. | Completion of intervention period (week 24) | |
Secondary | Energy expenditure (kcal/week) | Leisure-time physical activity will be assessed using the GSLTPAQ modified for the purpose of this study | Baseline (week 0) | |
Secondary | Energy expenditure (kcal/week) | Leisure-time physical activity will be assessed using the GSLTPAQ modified for the purpose of this study | End of control period and pre-intervention (week 8) | |
Secondary | Energy expenditure (kcal/week) | Leisure-time physical activity will be assessed using the GSLTPAQ modified for the purpose of this study | Middle of intervention period (week 16) | |
Secondary | Energy expenditure (kcal/week) | Leisure-time physical activity will be assessed using the GSLTPAQ modified for the purpose of this study | Completion of intervention period (week 24) | |
Secondary | Training volume (hours/week) | Training logs will be collected from participants and coaches | Baseline (week 0) | |
Secondary | Training volume (hours/week) | Training logs will be collected from participants and coaches | End of control period and pre-intervention (week 8) | |
Secondary | Training volume (hours/week) | Training logs will be collected from participants and coaches | Middle of intervention period (week 16) | |
Secondary | Training volume (hours/week) | Training logs will be collected from participants and coaches | Completion of intervention period (week 24) | |
Secondary | Nutrition knowledge | Participants' knowledge of nutrition will be assessed using the self-reported 97-item General and Sport-Specific Nutrition Knowledge Questionnaire (GeSNK) | Baseline (week 0) | |
Secondary | Nutrition knowledge | Participants' knowledge of nutrition will be assessed using the self-reported 97-item General and Sport-Specific Nutrition Knowledge Questionnaire (GeSNK) | Completion of intervention period (week 24) |
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