NCT06806501 Muscle Mass, Quality, and the Menopause: Sex-specific Strategies to Mitigate Sarcopenia in Ageing Populations
| NCT ID | NCT06806501 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Healthy |
| Study Type | OBSERVATIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-07-29 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 18 participants in total. It began in 2024-07-29 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. These strategies must be targeted, as evidence suggests that the loss in muscle size and strength is different between men and women throughout the aging process. For example, older women have greater levels of physical disability that includes difficulties in walking around the home, getting out of a bed or chair, and eating, compared with men. These sex differences with ageing are unclear, yet the greater levels of physical disability could be the result of the menopause. The menopause describes a change in the sex hormone environment that is a part of normal female ageing. Physical disability can be further enhanced by an increase in body fat during the menopause in the face of decreasing muscle mass. Currently, there is a lack of understanding as to how these changes in body composition occur, with no effective treatments against muscle mass loss. The aims of this project are to increase understanding on how the menopause impacts muscle mass regulation. In addition, the investigators will use novel magnetic resonance imaging (MRI) techniques to map the distribution of newly created fat, and qualitative interviews to better understand how resistance exercise therapy (RET) can be incorporated into the daily lives of postmenopausal women.
Eligibility Criteria
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. * Malignancy (or history of malignancy with 5 y). * Recent (within 6 mo) or current steroid treatment, hormone replacement therapy (HRT), hormonal contraception, or other hormonal therapies that may interfere with outcome measures. * Coagulopathy. * Musculoskeletal or neurological disorders. * Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance. * Amenorrhoea for a reason other than menopause. * Contraindications for Magnetic Resonance Imaging (MRI). * Allergy or sensitivity to local anaesthesia, or dressing adhesive. * Inner ear pathology or vertigo
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06806501 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06806501 currently recruiting?
Yes, NCT06806501 is actively recruiting participants. Contact the research team at Matthew.Brook@nottingham.ac.uk for enrollment information.
Where is the NCT06806501 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT06806501 clinical trial?
NCT06806501 is sponsored by University of Nottingham. The trial plans to enroll 18 participants.