Muscle Mass, Quality, and the Menopause: Sex-specific Strategies to Mitigate Sarcopenia in Ageing Populations

What this trial studies

Aging causes muscles to often become smaller and weaker resulting in physical frailty and functional impairments, such as difficulty raising from a chair, dressing, and preparing meals. In the UK there is a growing aged population with those \>65y expected to increase from 18% of the population in 2016, to 26% by 2066. As such, age related muscle mass loss and functional impairments represents one of the largest problems facing the health care services. There is an urgent need to develop strategies to reduce healthcare costs and improve health and wellbeing with age.

Conditions in scope

• Healthy

Interventions

• Unilateral Resistance Exercise (Behavioral) — Resistance exercise training session, consisting of 6 x 8 repetitions of leg extension (of the non-dominant leg) at 75% 1RM (repetition maximum) with 2 min rest between sets.

Who can join

Women only · Ages 18 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Biological woman, 18-65 years of age
• Body mass index (BMI) 18-30 kg/m2
• Non smoker
• Not performing regular resistance type exercise
• Participant is willing and able to give informed consent for participation in the study

Exclusion criteria

• A BMI \<18 or \>39 kg·m-2
• Active cardiovascular disease: uncontrolled hypertension (Blood pressure \> 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event.
• Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)
• Respiratory disease including pulmonary hypertension or Chronic obstructive pulmonary disease (COPD).
• Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes (treated and untreated), polycystic ovarian syndrome (PCOS), inborn/ congenital errors of metabolism (e.g. Phenylketonuria (PKU), galactosaemia)
• Active inflammatory bowel disease.
• Acute infection.
• Acute or chronic renal disease.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2024-07-29
• Primary completion: 2026-03
• Last update posted: 2025-02-04
• First posted: 2025-02-04

Sponsor & contact

Lead sponsor: University of Nottingham (Other)

Collaborators: Medical Research Council

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Rate of muscle protein synthesis (3 Days)
  Comparison between pre and post menopausal women of vastus lateralis muscle protein synthesis in response to acute unilateral resistance exercise and at rest using deuterium oxide stable isotope techniques.
• Rate of muscle protein breakdown (3 Days)
  Comparison between pre and post menopausal women of whole body muscle protein breakdown in response to acute unilateral resistance exercise and at rest using D3-3-methylhistidine

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