12 weeks of strength training and high protein consumption in perimenopausal females
| ISRCTN | ISRCTN20867728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20867728 |
| Protocol serial number | HiREB #18538 |
| Sponsor | Dairy Farmers Of Canada |
| Funders | Dairy Farmers of Canada, Mitacs, Natural Sciences and Engineering Research Council of Canada |
- Submission date
- 05/01/2026
- Registration date
- 08/01/2026
- Last edited
- 07/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Perimenopause is a transitional period in the female life cycle involving significant changes to the hormonal, energy processing, and musculoskeletal systems of the body. Diet and exercise are key strategies for managing the development of some of these changes including increased body fat and the associated negative health effects. Dairy products are accessible whole foods that are rich sources of important nutrients, and previous research has shown that when combined with exercise, dairy products can improve fat loss and increase muscle mass gain in adults and adolescent females, however it is unknown if these findings also apply to females during perimenopause.
Who can participate?
Healthy, sedentary, perimenopausal females aged 40-60 years
What does the study involve?
After screening and informed consent is obtained, participants will attend the lab and have the following baseline measures assessed: body composition (fat, bone, and lean mass) measured using DEXA, muscle mass measured by D3-creatine dilution, blood, fecal sample, muscle biopsy sample, strength testing and menopausal and other health/symptom questionnaires.
Participants will then be randomly allocated into a nutrition condition that is consumed daily and consists of either:
1. Two 175 g of a high-protein Greek-style yogurt + 90 ml of a probiotic yogurt drink, or
2. An energy and protein matched, collagen + carbohydrate pudding supplement
They will also be randomly allocated into one of two progressive exercise training programs, both involving twice weekly supervised gym-based full-body resistance exercises for 12 weeks, and either:
1. Higher load (3 sets, 8-12 reps to failure), or
2. Lower load (3 sets, 20-25 reps to failure)
After 12 weeks, participants will return to the lab to repeat the rested, fasted baseline measurements.
What are the possible benefits and risks of participating?
Risks: the risks of this study include discomfort, fatigue, and delayed onset of muscle soreness from the resistance exercise training, low-dose radiation from the dual x-ray absorptiometry scan, bruising, infection, and discomfort from the muscle biopsies/blood sampling, and possible cyber-related privacy breach.
Benefits: each participant will receive an honorarium of $200 upon the completion of the study to compensate them for their time. Resistance exercise training may improve their muscle mass and strength which has been shown numerous times to have health long term benefits.
Where is the study run from?
McMaster University (Canada)
When is the study starting and how long is it expected to last?
January 2026, expected to run for ~1-2 years
Who is funding the study?
1. Dairy Farmers of Canada
2. MITACS
3. Natural Sciences and Engineering Research Council of Canada (NSERC)
Who is the main contact?
Dr Stuart Phillips, phillis@mcmaster.ca
Contact information
Principal investigator
1280 Main Street West
Department of Kinesiology
McMaster University
Hamilton
L8S4K1
Canada
| 0000-0002-1956-4098 | |
| Phone | +1 (0)905 525 4140 ext 24465 |
| phillis@mcmaster.ca |
Public, Scientific
1280 Main Street West
Department of Kinesiology
McMaster University
Hamilton
L8S4K1
Canada
| 0000-0003-1929-6983 | |
| Phone | +1 (0)905 525 9140 Ext. 21918 |
| prowtinj@mcmaster.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel interventional double-blind randomized control trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The combined effect of yogurt consumption with resistance exercise on body composition and inflammation in perimenopausal females |
| Study acronym | SPRY |
| Study objectives | The objective of our proposed study is to determine whether 12 weeks of resistance exercise combined with three daily servings of yogurt (2 x high-protein Greek-style yogurt and 1 x probiotic yogurt drink) enhances body composition adaptations (i.e., reduced body fat and increased lean mass) and other related health markers (i.e., gut microbiome, menopausal symptom questionnaires, bone turnover, and inflammatory biomarkers) compared with an isonitrogenous, isoenergetic (carbohydrate + collagen) supplement in perimenopausal females. Females, particularly those transitioning through menopause, can undergo deleterious and accelerated physiological changes and have been vastly underrepresented in published trials; thus, strategies to enhance their health and wellbeing must be developed and optimized. |
| Ethics approval(s) |
Approved 07/06/2025, Hamilton Integrated Research Ethics Board (237 Barton Street East, Hamilton, L8L 2X2, Canada; +1 (0)905 521 2100 ext 42013; belle@hhsc.ca), ref: 18538 |
| Health condition(s) or problem(s) studied | Perimenopausal females |
| Intervention | This study has two nutrition supplement groups, which are consumed twice daily for 12 weeks. They consist of: 1. Intervention: 350 g high protein 0% Greek Yogurt 2. Energy and protein matched control group: 40 g collagen, 15 g thicken-up, 39 g vanilla instant pudding. The participants will also complete two supervised, full-body resistance training sessions twice per week, with the type of training randomized into either: 1. Higher-load group (8-12 repetitions before failure) 2. Lower-load group (20-25 repetitions before failure) Both groups will complete an additional 1x at-home workout that consists of full body aerobic/high-intensity interval exercise. Randomisation will be completed by the registered dietitian using an online randomisation software and generated before subjects enter the protocol. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Body composition measured using dual x-ray absorptiometry (DXA) at baseline and after 12 weeks |
| Key secondary outcome measure(s) |
1. Skeletal muscle mass measured using D3-creatine at baseline and after 12 weeks |
| Completion date | 01/01/2028 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Mixed |
| Lower age limit | 35 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Be in the perimenopausal period (Stage -1 or -2 assessed using the STRAW+10 guidelines) . 2. Be untrained/sedentary (<2 structured exercise sessions per week). 3. Low habitual dairy consumption (≤1 serving of milk, yogurt, cheese/day). 4. Be able to maintain a habitual diet and safe to perform RET three times per week throughout the trial (assessed by the “Get Active” Questionnaire). 5. Understand the study procedures and provide informed consent to participate in the study. |
| Key exclusion criteria | 1. Regular use of tobacco- or cannabis-related products (smoking, chewing or vaping). 2. Have any electronic medical or metal implants. 3. Currently pregnant or planning to get pregnant. 4. Allergy to dairy foods or lactose intolerance. 5. Orthopaedic conditions (MSK injury, chronic back pain etc) that may worsen with exercise. 6. Any acute or chronic illness relating to the cardiac, pulmonary, skeletal or neuromuscular systems, Type 1 diabetes or unmanaged hypertension, lipidaemia or cardiovascular disease or any other medical concern that may interfere with their ability to safely complete the study. 7. Regular use of medications known to affect protein metabolism or inflammation (i.e. corticosteroids, non-steroidal anti-inflammatory drugs (prescription use or daily use of over-the-counter medication), or prescription strength acne medications). 8. Concurrent participation in a research study that may interfere with the results of the current study. |
| Date of first enrolment | 06/01/2026 |
| Date of final enrolment | 01/10/2027 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hamilton
L8S 4L8
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data-sharing plans for the current study are that all data will be made publicly available upon reasonable request from the PI, Dr Stuart Phillips (phillis@mcmaster.ca). |
Editorial Notes
06/01/2026: Study's existence confirmed by the Hamilton Integrated Research Ethics Board.