Clinical trial NCT06946316: Dairy vs Plant-based Beverages for Improving Bone Health During Exercise
Official title: Dairy Versus Plant-based Beverages Combined With Resistance-training for Improving Bone Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effects of consuming dairy milk versus two plant-based beverages (pea-based, and almond-based) after resistance training sessions (3 times per week for 12 months) on bone properties (bone mineral density, bone geometry), body composition, strength, and functional performance in post-menopausal women and men 50y and older.

Detailed description: The purpose of the study is to compare consumption of dairy milk (1% chocolate milk) to plant-based beverages (protein-matched pea beverage and low-protein almond beverage) after resistance-training sessions on bone mineral density, bone geometric properties, lean tissue and fat mass, muscular strength, and functional performance. One-hundred and fifty postmenopausal women and men 50y or older will be randomized to one of three groups: 1) Dairy milk; 2) pea-beverage; 3) almond beverage. The study will be double-blind, accomplished by chocolate flavoring of each beverage. Participants will do supervised strength-training sessions three times per week for 12 months. After each strength-training session, participants will consume 375 ml of their beverage and then consume 375 ml of their beverage again one hour later.

Eligibility criteria: Inclusion Criteria:

* Women need to be postmenopausal (no age limit)
* Men need to be 50y or older

Exclusion Criteria:

* Taking medications that might affect bone
* Conditions that might preclude participating in a resistance-training program (determined by the "Get Active Questionnaire").
* Planning 6 weeks of travel during the 12 month intervention period
* Planning major surgery during the 12 month intervention period
* Already strength training greater than 2 days per week for 30 minutes or longer per session
* Allergies to ingredients in the beverages

Primary outcomes:
measure: Change in section modulus at the hip (cm to the power of 3)
timeFrame: 12 months
Secondary outcomes:
measure: Change in lumbar spine bone mineral density (g/cm-squared)
timeFrame: 12 months
measure: Change in hip bone mineral density (g/cm-squared)
timeFrame: 12 months
measure: Change in cross-sectional area at the hip (cm-squared)
timeFrame: 12 months
measure: Change in cortical thickness at the hip (cm)
timeFrame: 12 months
measure: Change in buckling ratio at the hip (no units)
timeFrame: 12 months
measure: Change in bench press strength (kg)
timeFrame: 6 and 12 months
measure: Change in knee extension strength (kg)
timeFrame: 6 and 12 months
measure: Change in lean tissue mass (kg)
timeFrame: 12 months
measure: Change in fat mass (kg)
timeFrame: 12 months
measure: change in 30 second sit to stand (number of repetitions)
timeFrame: 6 and 12 months
measure: Change in walking speed (m/s)
timeFrame: 6 and 12 months
measure: Change in timed up and go performance (s)
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Kinesiology University of Saskatchewan
state: Saskatchewan
Study officials:
References: