Dairy ProductsNCT04981652
The Effect of Whole Milk to Improve Muscle Health in Older Women
A study testing Whole Milk, Skim Milk and Almond Beverage in people with Dairy Products and Muscle Protein Synthesis, run by McMaster University at 1 site in Canada.
Trial summary
Muscle and strength begin to noticeably decline around 50 years of age, increasing an individual's risk for disease and disability. Although changes in muscle mass ultimately depend on the balance of muscle protein synthesis (MPS) and breakdown (MPB) of muscle proteins, the latter remains relatively constant with… Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dairy Products, Muscle Protein Synthesis, Aging
- What is being tested?
- Whole Milk, Skim Milk and Almond Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 60-75 years (inclusive)
- Be at least 5 years post-menopausal
- Have a body mass index (BMI) between 20-35 kg/m2
- Be able to maintain a habitual diet, physical activity patterns, and body mass throughout the trial
- Be in general good health
- Understand the study procedures and sign this form providing informed consent to participate in the study.
- Understand the study procedures and sign the form providing informed consent to participate in the study.
Who cannot join
- Use of tobacco or related products
- Use assistive walking devices (e.g., cane or walker)
- A history of neuromuscular problems or muscle and/or bone wasting diseases
- Any acute or chronic illness; cardiac, pulmonary, liver, or kidney abnormalities; insulin- or non-insulin-dependent diabetes or other metabolic disorders (all ascertained through medical questionnaires)
- Use of medications known to affect protein metabolism (i.e. corticosteroids, nonsteroidal anti-inflammatory drugs (prescription use or daily use of over the counter medication), or prescription strength acne medications)
- Use of anticoagulant medication
Show all 9Show fewer
- History of statin myalgia
- Allergy to lactose or almonds
- Consuming a vegan diet
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: Whole Milk to Augment Muscle Protein Synthesis in Older Women: a Randomized Controlled Trial
Muscle and strength begin to noticeably decline around 50 years of age, increasing an individual's risk for disease and disability. Although changes in muscle mass ultimately depend on the balance of muscle protein synthesis (MPS) and breakdown (MPB) of muscle proteins, the latter remains relatively constant with aging. Accordingly, interventions that increase rates of MPS may combat long-term decrements in skeletal muscle mass and function. Previous research has established that an optimal diet to maintain muscle mass in elderly individuals requires relatively large amounts of high-quality protein to be consumed at each meal of the day. While this is a seemingly simple strategy, there are some barriers to increasing protein feeding in elderly individuals, particularly the cost of high-quality protein and, sometimes, difficulty with chewing/swallowing. Moreover, older adults often do not wish to consume large portions of protein in one meal.
Milk is a readily accessible, affordable and nutritious source of nutrient-dense high-quality protein. Consuming milk with each meal is an easy strategy to promote the maintenance of skeletal muscle mass with aging. There is also evidence suggesting that a higher fat content of milk can have a beneficial role in stimulating the MPS response to feeding, but there are insufficient data to recommend this strategy to elderly individuals.
The primary aim is to measure the rates of MPS in response to controlled diets providing whole milk, fat-free milk, or a control supplement (almond beverage - often marketed as an 'alternative' to milk) with each meal. All diets will provide equal amounts of energy, but the dairy interventions will provide more protein, reflecting the amount of protein provided by each beverage. The investigators hypothesize that rates of MPS will be highest in the whole milk group but that fat-free milk will still elicit a greater MPS than almond beverage. The investigators will conduct the comparison of beverages under habitual physical activity levels and under a brief period of increased physical activity (i.e., increased daily steps). Thus, the investigators will be able to determine whether MPS responses to the experimental beverages are increased in combination with physical activity. The results will provide evidence regarding the effectiveness of daily milk ingestion for the maintenance of muscle in the elderly, increasing the marketability of milk, and potentially whole milk.
- Conditions
- Dairy Products, Muscle Protein Synthesis, Aging, Physical Activity
- Being tested
- Whole Milk, Skim Milk, Almond Beverage
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole MilkDietary supplement
Participants will consume twice daily whole milk beverages in addition to a standardized diet.
Skim MilkDietary supplement
Participants will consume twice daily skim milk beverages in addition to a standardized diet.
Almond BeverageDietary supplement
Participants will consume twice daily almond beverages in addition to a standardized diet.
| Study group | Role | What they receive |
|---|---|---|
| Whole Milk | Experimental | Participants randomly assigned to the whole milk condition will undergo three sequential study phases, each lasting three days in length. During phase 1, these participants will participate in habitual physical activity and consume a standardized diet, delivering 0.8 g/kg/body mass per day of protein. During the second phase, participants in this group will continue to perform habitual activity, but will have two whole milk experimental beverages (250 mL each serving, 3% milk fat) added to their standardized diet each day for the three day period. Finally, during the last three days of the study, participants will continue to consume the their intervention diet, but their physical activity levels (monitored via daily step count) will be increased to ~150% of their habitual levels. Receives: Dietary Supplement: Whole Milk |
| Skim Milk | Experimental | Participants randomly assigned to the skim milk condition will undergo three sequential study phases, each lasting three days in length. During phase 1, these participants will participate in habitual physical activity and consume a standardized diet, delivering 0.8 g/kg/body mass per day of protein. During the second phase, participants in this group will continue to perform habitual activity, but will have two skim milk experimental beverages (250 mL each serving, 0% milk fat) added to their standardized diet each day for the three day period. Finally, during the last three days of the study, participants will continue to consume the their intervention diet, but their physical activity levels (monitored via daily step count) will be increased to ~150% of their habitual levels. Receives: Dietary Supplement: Skim Milk |
| Almond Beverage | Experimental | Participants randomly assigned to the almond beverage condition will undergo three sequential study phases, each lasting three days in length. During phase 1, these participants will participate in habitual physical activity and consume a standardized diet, delivering 0.8 g/kg/body mass per day of protein. During the second phase, participants in this group will continue to perform habitual activity, but will have two almond experimental beverages (250 mL each serving) added to their standardized diet each day for the three day period. Finally, during the last three days of the study, participants will continue to consume the their intervention diet, but their physical activity levels (monitored via daily step count) will be increased to ~150% of their habitual levels. Receives: Dietary Supplement: Almond Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
Muscle protein synthesis will be calculated by determining the change in deuterated alanine enrichment in skeletal muscle proteins over each study phase
Measured: Assessed at baseline (day 0-3), intervention diet (4-7) and intervention diet + activity (day 8-10)
Secondary outcomes (1)
Western Blotting
The protein content of mechanistic target of rapamycin (mTOR) signalling components (i.e., mTOR, eIF4E-binding protein 1 (4EBP1), p70S6K and ribosomal protein S6 (rpS6) will be assessed
Measured: Assessed at baseline (day 0-3), intervention diet (4-7) and intervention diet + activity (day 8-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Jun 2018
- Primary completion1 Mar 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dairy ProductsStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomly assigned to one of three intervention groups (whole milk, skim milk or almond beverage)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981652
- Sponsor's protocol ID
- HIREB 4832
- Status last verified
- Apr 2022
- First submitted
- 19 Jul 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stokes T, Mei Y, Seo F, McKendry J, McGlory C, Phillips SM. Dairy and Dairy Alternative Supplementation Increase Integrated Myofibrillar Protein Synthesis Rates, and Are Further Increased when Combined with Walking in Healthy Older Women. J Nutr. 2022 Jan 11;152(1):68-77. doi: 10.1093/jn/nxab358.
PubMed 34610129
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Milk to Augment Muscle Protein Synthesis in Older Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04981652
- Acronym / sponsor ID
- HIREB 4832
- Conditions
- Dairy Products, Muscle Protein Synthesis, Aging, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Muscle and strength begin to noticeably decline around 50 years of age, increasing an individual's risk for disease and disability. Although changes in muscle mass ultimately depend on the balance of muscle protein synthesis (MPS) and breakdown (MPB) of muscle proteins, the latter remains relatively constant with aging. Accordingly, interventions that increase rates of MPS may combat long-term decrements in skeletal muscle mass and function. Previous research has established that an optimal diet to maintain muscle mass in elderly individuals requires relatively large amounts of high-quality protein to be consumed at each meal of the day. While this is a seemingly simple strategy, there are some barriers to increasing protein feeding in elderly individuals, particularly the cost of high-quality protein and, sometimes, difficulty with chewing/swallowing. Moreover, older adults often do not wish to consume large portions of protein in one meal.
Milk is a readily accessible, affordable and nutritious source of nutrient-dense high-quality protein. Consuming milk with each meal is an easy strategy to promote the maintenance of skeletal muscle mass with aging. There is also evidence suggesting that a higher fat content of milk can have a beneficial role in stimulating the MPS response to feeding, but there are insufficient data to recommend this strategy to elderly individuals.
The primary aim is to measure the rates of MPS in response to controlled diets providing whole milk, fat-free milk, or a control supplement (almond beverage - often marketed as an 'alternative' to milk) with each meal. All diets will provide equal amounts of energy, but the dairy interventions will provide more protein, reflecting the amount of protein provided by each beverage. The investigators hypothesize that rates of MPS will be highest in the whole milk group but that fat-free milk will still elicit a greater MPS than almond beverage. The investigators will conduct the comparison of beverages under habitual physical activity levels and under a brief period of increased physical activity (i.e., increased daily steps). Thus, the investigators will be able to determine whether MPS responses to the experimental beverages are increased in combination with physical activity. The results will provide evidence regarding the effectiveness of daily milk ingestion for the maintenance of muscle in the elderly, increasing the marketability of milk, and potentially whole milk.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants randomly assigned to one of three intervention groups (whole milk, skim milk or almond beverage)
| Arm | Type | Receives |
|---|---|---|
| Whole Milk | Experimental | Dietary Supplement: Whole MilkParticipants randomly assigned to the whole milk condition will undergo three sequential study phases, each lasting three days in length. During phase 1, these participants will participate in habitual physical activity and consume a standardized diet, delivering 0.8 g/kg/body mass per day of protein. During the second phase, participants in this group will continue to perform habitual activity, but will have two whole milk experimental beverages (250 mL each serving, 3% milk fat) added to their standardized diet each day for the three day period. Finally, during the last three days of the study, participants will continue to consume the their intervention diet, but their physical activity levels (monitored via daily step count) will be increased to ~150% of their habitual levels. |
| Skim Milk | Experimental | Dietary Supplement: Skim MilkParticipants randomly assigned to the skim milk condition will undergo three sequential study phases, each lasting three days in length. During phase 1, these participants will participate in habitual physical activity and consume a standardized diet, delivering 0.8 g/kg/body mass per day of protein. During the second phase, participants in this group will continue to perform habitual activity, but will have two skim milk experimental beverages (250 mL each serving, 0% milk fat) added to their standardized diet each day for the three day period. Finally, during the last three days of the study, participants will continue to consume the their intervention diet, but their physical activity levels (monitored via daily step count) will be increased to ~150% of their habitual levels. |
| Almond Beverage | Experimental | Dietary Supplement: Almond BeverageParticipants randomly assigned to the almond beverage condition will undergo three sequential study phases, each lasting three days in length. During phase 1, these participants will participate in habitual physical activity and consume a standardized diet, delivering 0.8 g/kg/body mass per day of protein. During the second phase, participants in this group will continue to perform habitual activity, but will have two almond experimental beverages (250 mL each serving) added to their standardized diet each day for the three day period. Finally, during the last three days of the study, participants will continue to consume the their intervention diet, but their physical activity levels (monitored via daily step count) will be increased to ~150% of their habitual levels. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be between the ages of 60-75 years (inclusive)
- Be at least 5 years post-menopausal
- Have a body mass index (BMI) between 20-35 kg/m2
- Be able to maintain a habitual diet, physical activity patterns, and body mass throughout the trial
- Be in general good health
Key exclusion criteria (9 listed)
- Use of tobacco or related products
- Use assistive walking devices (e.g., cane or walker)
- A history of neuromuscular problems or muscle and/or bone wasting diseases
- Any acute or chronic illness; cardiac, pulmonary, liver, or kidney abnormalities; insulin- or non-insulin-dependent diabetes or other metabolic disorders (all ascertained through medical questionnaires)
- Use of medications known to affect protein metabolism (i.e. corticosteroids, nonsteroidal anti-inflammatory drugs (prescription use or daily use of over the counter medication), or prescription strength acne medications)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole MilkParticipants will consume twice daily whole milk beverages in addition to a standardized diet. | Dietary supplement | Whole Milk |
| Skim MilkParticipants will consume twice daily skim milk beverages in addition to a standardized diet. | Dietary supplement | Skim Milk |
| Almond BeverageParticipants will consume twice daily almond beverages in addition to a standardized diet. | Dietary supplement | Almond Beverage |
Primary outcome
Muscle Protein Synthesis
Time frame: Assessed at baseline (day 0-3), intervention diet (4-7) and intervention diet + activity (day 8-10)
Muscle protein synthesis will be calculated by determining the change in deuterated alanine enrichment in skeletal muscle proteins over each study phase
1 secondary outcome
Western Blotting
Time frame: Assessed at baseline (day 0-3), intervention diet (4-7) and intervention diet + activity (day 8-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Results publication: PubMed 34610129Stokes T, Mei Y, Seo F, McKendry J, McGlory C, Phillips SM. Dairy and Dairy Alternative Supplementation Increase Integrated Myofibrillar Protein Synthesis Rates, and Are Further Increased when Combined with Walking in Healthy Older Women. J Nutr. 2022 Jan 11;152(1):68-77. doi: 10.1093/jn/nxab358.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Milk, Skim Milk and Almond Beverage in people with Dairy Products and Muscle Protein Synthesis, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis (time frame: Assessed at baseline (day 0-3), intervention diet (4-7) and intervention diet + activity (day 8-10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.