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OpenTrials
Completed

NCT Number: NCT04981652

The Effect of Whole Milk to Improve Muscle Health in Older Women

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.

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Key information

Age range

60 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • History of statin myalgia
  • Allergy to lactose or almonds
  • Consuming a vegan diet

Treatment and study plan

Whole Milk

Dietary Supplement

Participants will consume twice daily whole milk beverages in addition to a standardized diet.

Skim Milk

Dietary Supplement

Participants will consume twice daily skim milk beverages in addition to a standardized diet.

Almond Beverage

Dietary Supplement

Participants will consume twice daily almond beverages in addition to a standardized diet.

Primary outcomes

  1. 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

Secondary outcomes

  1. Western Blotting

    Time frame: Assessed at baseline (day 0-3), intervention diet (4-7) and intervention diet + activity (day 8-10)

    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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Whole Milk to Augment Muscle Protein Synthesis in Older Women: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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