NCT06530394

Brief Summary

This study aims to examine whether Greek yogurt (GY) consumption will lead to beneficial changes in bone metabolism and inflammation, in senior adults, male and female, when combined with regular exercise (senior fit classes; GYEX) and without exercise (GYNE). It is hypothesized that compared to a control group (senior fit classes, no GY; NYEX), an 8-week GY consumption intervention in senior adults with and without exercise will lead to positive effects on body composition, and markers of bone metabolism and inflammation such that the anabolic and anti-inflammatory markers of these physiological processes will increase more than any training-induced catabolic and pro-inflammatory markers (i.e., more than measures observed in the NYNE group).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

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

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

July 28, 2024

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (12)

  • Serum concentrations of osteocalcin

    Bone turnover marker measured in picograms/milliliter of serum (pg/mL)

    Weeks 0 and 8

  • Serum concentrations of amino-terminal propeptide of type I collagen (P1NP)

    Bone formation marker measured in pg/mL

    Weeks 0 and 8

  • Serum concentrations of C-telopeptides of type I collagen (CTX)

    Bone resorption marker measured in ng/mL

    Weeks 0 and 8

  • Serum concentrations of osteoprotegerin (OPG)

    Regulator of bone remodelling (osteokine) measured in pg/mL

    Weeks 0 and 8

  • Serum concentrations of sclerostin

    Regulator of bone remodelling (osteokine) measured in pg/mL

    Weeks 0 and 8

  • Serum concentrations of receptor activator of nuclear factor kappa-Β ligand (RANKL)

    Regulator of bone remodelling (osteokine) measured in pg/mL

    Weeks 0 and 8

  • Serum concentrations of parathyroid hormone (PTH)

    Regulator of bone remodelling measured in pg/mL

    Weeks 0 and 8

  • Plasma concentrations of interleukin-6 (IL6)

    Inflammatory cytokine measured in pg/mL

    Weeks 0 and 8

  • Plasma concentrations of interleukin-10 (IL10)

    Anti-inflammatory cytokine measured in pg/mL

    Weeks 0 and 8

  • plasma concentrations of inflammatory cytokines, including interleukin-6 (IL6), interleukin-10 Plasma concentrations of tumour necrosis factor-alpha (TNFα)

    Pro-inflammatory cytokine measured in pg/mL

    Weeks 0 and 8

  • Serum concentrations of irisin

    Myokine measured in pg/mL

    Weeks 0 and 8

  • Serum concentrations of insulin-like growth factor 1 (IGF1)

    Growth factor measured in pg/mL

    Weeks 0 and 8

Secondary Outcomes (5)

  • Body mass

    Weeks 0 and 8

  • Body composition

    Weeks 0 and 8

  • Height

    Weeks 0 and 8

  • Energy intake and expenditure

    Weeks 0 and 8

  • Sport-Specific Nutrition Knowledge Questionnaire (GeSNK)

    Weeks 0 and 8

Study Arms (3)

Greek yogurt exercising group (GYEX)

EXPERIMENTAL

Participants will be asked to consume 2 servings/day (preferably morning and night) of 175 g commercially available GY (0% MF, flavoured, 130 calories, 17 g protein, 225 g calcium (e.g., OIKOS High Protein GY) for a total of 8 weeks. For their convenience, the participants 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 daily routines and lifestyles. For the same reasons, the participants will be able to choose the flavour of their GY.

Dietary Supplement: Greek yogurt

Control exercising group (NYEX)

NO INTERVENTION

During the 8-weeks, participants will be instructed to follow their typical, habitual diet and exercise regimen.

Intervention non-exercising group (GYNE)

ACTIVE COMPARATOR

Participants will be instructed to follow their typical habitual diet. Participants will be asked to consume 2 servings/day (preferably morning and night) of 175 g commercially available GY (0% MF, flavoured, 130 calories, 17 g protein, 225 g calcium; e.g., OIKOS High Protein GY) for a total of 8 weeks. For their convenience, the participants 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 intervention's feasibility, the servings' timing will be flexible to facilitate daily routines and lifestyles. For the same reasons, the participants will be able to choose the flavour of their GY.

Dietary Supplement: Greek yogurt

Interventions

Greek yogurtDIETARY_SUPPLEMENT

Whole food dairy products, such as Greek yogurt (GY), offer a high quality, nutrient-dense snack, high in bone-supporting ingredients, including protein, calcium, and phosphorus. These nutrients are crucial to the structural integrity and strength of bone, i.e., the collagen and hydroxyapatite matrices.

Greek yogurt exercising group (GYEX)Intervention non-exercising group (GYNE)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 55+ years from from the Niagara area.

You may not qualify if:

  • injuries and inability to participate in classes,
  • allergy to dairy foods/dairy protein, or
  • diagnosed with lactose intolerance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

MeSH Terms

Conditions

OsteoporosisInflammation

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent blind researchers will analyze blood and data using masked participant codes.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be invited to participate in this 8-week study, with senior fit participants being randomly assigned into the control (NYEX) or the intervention exercising (GYEX) group and non-senior fit citizens from the Niagara community will be assigned to the intervention non-exercising group (GYNE).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

August 10, 2024

Primary Completion

June 30, 2025

Study Completion

August 28, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Locations