NCT05922462

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

June 4, 2023

Last Update Submit

December 28, 2024

Conditions

Bone Growth AbnormalInflammation

Keywords

AthletesBone markersInflammatory cytokinesGreek yogurtWhey protein

Outcome Measures

Primary Outcomes (40)

  • Osteocalcin

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

    Baseline (week 0)

  • Osteocalcin

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

    End of control period and pre-intervention (week 8)

  • Osteocalcin

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

    Middle of intervention period (week 16)

  • Osteocalcin

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

    Completion of intervention period (week 24)

  • Amino-terminal propeptide of type I collagen (P1NP)

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

    Baseline (week 0)

  • 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)

  • 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)

  • 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)

  • Osteoprotegerin (OPG)

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

    Baseline (week 0)

  • Osteoprotegerin (OPG)

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

    End of control period and pre-intervention (week 8)

  • Osteoprotegerin (OPG)

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

    Middle of intervention period (week 16)

  • Osteoprotegerin (OPG)

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

    Completion of intervention period (week 24)

  • C-telopeptides of type I collagen (CTX)

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

    Baseline (week 0)

  • 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)

  • 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)

  • 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)

  • Sclerostin

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

    Baseline (week 0)

  • Sclerostin

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

    End of control period and pre-intervention (week 8)

  • Sclerostin

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

    Middle of intervention period (week 16)

  • Sclerostin

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

    Completion of intervention period (week 24)

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

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

    Baseline (week 0)

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

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

    End of control period and pre-intervention (week 8)

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

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

    Middle of intervention period (week 16)

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

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

    Completion of intervention period (week 24)

  • Parathyroid hormone (PTH)

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

    Baseline (week 0)

  • Parathyroid hormone (PTH)

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

    End of control period and pre-intervention (week 8)

  • Parathyroid hormone (PTH)

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

    Middle of intervention period (week 16)

  • Parathyroid hormone (PTH)

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

    Completion of intervention period (week 24)

  • Interleukin-6 (IL6)

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

    Baseline (week 0)

  • Interleukin-6 (IL6)

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

    End of control period and pre-intervention (week 8)

  • Interleukin-6 (IL6)

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

    Middle of intervention period (week 16)

  • Interleukin-6 (IL6)

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

    Completion of intervention period (week 24)

  • Interleukin-10 (IL10)

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

    Baseline (week 0)

  • 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)

  • Interleukin-10 (IL10)

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

    Middle of intervention period (week 16)

  • Interleukin-10 (IL10)

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

    Completion of intervention period (week 24)

  • Tumour necrosis factor-alpha (TNFα)

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

    Baseline (week 0)

  • Tumour necrosis factor-alpha (TNFα)

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

    End of control period and pre-intervention (week 8)

  • Tumour necrosis factor-alpha (TNFα)

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

    Middle of intervention period (week 16)

  • Tumour necrosis factor-alpha (TNFα)

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

    Completion of intervention period (week 24)

Secondary Outcomes (50)

  • Insulin-like growth factor 1 (IGF1)

    Baseline (week 0)

  • Insulin-like growth factor 1 (IGF1)

    End of control period and pre-intervention (week 8)

  • Insulin-like growth factor 1 (IGF1)

    Middle of intervention period (week 16)

  • Insulin-like growth factor 1 (IGF1)

    Completion of intervention period (week 24)

  • Testosterone

    Baseline (week 0)

  • +45 more secondary outcomes

Study Arms (2)

Greek yogurt intervention group (GY)

EXPERIMENTAL

Participants in the GY group will be instructed by a registered dietician to consume 2 servings/day (preferably morning and night) of 175 g GY (0% MF, flavoured, 130 calories, 17 g protein, 225 g calcium; e.g., OIKOS High Protein GY) for a total of 16 weeks. For their convenience, the athletes will be provided with appropriate scoops to measure out 175 g of GY per serving of the larger 650 g commercially available, pre-packaged containers. Although it is recommended to consume the two servings morning and night, to increase ecological validity and strengthen the feasibility of the intervention, the timing of the servings will be flexible to facilitate the training and competition routines. For the same reasons, the athletes will be able to choose the flavour of their GY.

Dietary Supplement: Greek yogurt

Whey protein intervention group (WP)

EXPERIMENTAL

Participants in the WP group will follow a similar consumption schedule but will be instructed by the RD to consume two servings/day (preferably morning and night) each of 2/3 of a scoop of commercially available WP powder (flavoured, \~29 g, 120 calories, 19 g protein, 112.5 g calcium; e.g., PURE Whey Protein, Walmart) for a total of 16 weeks. The WP scoop will be dissolved in water (e.g., 1 g of WP isolate to 10 mL of water, as recommended by the manufacturer). This protein dose is similar to the previous dose in young swimmers and comparable to other studies in adults. Athletes will be provided with appropriately marked scoops (corresponding to 2/3 of the manufacturer scoop) to measure their single servings. Each athlete will receive two large containers (2 x 907 g = 1814 g per week) at the beginning of each week, which will be enough to cover the two daily servings of 29 g (i.e., 58 g/day).

Dietary Supplement: Whey protein

Interventions

Greek yogurtDIETARY_SUPPLEMENT

For 16 weeks, athletes will consume 2 servings/day of 175 g GY (0% MF, flavoured, 130 calories, 17 g protein, 225 g calcium; e.g., OIKOS High Protein GY)

Greek yogurt intervention group (GY)
Whey proteinDIETARY_SUPPLEMENT

For 16 weeks, athletes will consume 2 servings/day of 2/3 of a scoop of commercially available WP powder (flavoured, \~29 g, 120 calories, 19 g protein, 112.5 g calcium; e.g., PURE Whey Protein, Walmart)

Whey protein intervention group (WP)

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Competitive youth or varsity athletes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

RECRUITING

MeSH Terms

Conditions

Bone Diseases, DevelopmentalInflammation

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Panagiota Klentrou, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Panagiota Klentrou, PhD

CONTACT

9056885550nklentrou@brocku.ca

Madison Bell, MSc

CONTACT

7052793113mb14pf@brocku.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study will use a randomized controlled parallel design, where participants will be randomly assigned to either to consume greek yogurt or whey protein for 16 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2023

First Posted

June 28, 2023

Study Start

September 1, 2023

Primary Completion

August 30, 2025

Study Completion

April 30, 2026

Last Updated

December 31, 2024

Record last verified: 2024-12

Locations

CA(1)