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

NCT06806501 | Recruiting

• 1 other identifier: FMHS 129-0224
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Rate of muscle protein synthesis

  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.

  3 Days

• Rate of muscle protein breakdown

  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

  3 Days

Secondary Outcomes (7)

• Whole body muscle mass

  At the point of enrolment

• Quadriceps fat mass

  At the point of enrolment

• Menopausal symptoms

  At the point of enrolment

• Knee extensor strength

  At the point of enrolment

• De novo lipogenesis

  0 - 8 weeks

Study Arms (2)

Premenopausal

Defined as having a menstrual cycle and having plasma follicle-stimulating hormone (FSH) \<30 IU/L, taken during days 1-5 of their menstrual cycle.

Behavioral: Unilateral Resistance Exercise

Postmenopausal

Defined as having no menses for 12 months, E2 (Oestradiol) \< 118pmol/L and FSH \>30 IU/L.

Behavioral: Unilateral Resistance Exercise

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.

Postmenopausal; Premenopausal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be healthy females aged 18 - 65, who are not on hormonal replacement therapy or hormonal contraceptives and are not participating in regular resistance exercise. Participants will fall into two groups: * Premenopausal, defined as having a menstrual cycle and having plasma follicle-stimulating hormone (FSH) \<30 IU/L, taken during days 1-5 of their menstrual cycle. * Postmenopausal, defined as having no menses for 12 months, E2 (Oestradiol) \< 118pmol/L and FSH \>30 IU/L.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nottingham: lead
• Medical Research Council: collaborator

Study Sites (1)

Queens Medical Centre Campus

Nottingham, United Kingdom

RECRUITING

Central Study Contacts

Matthew Brook

CONTACT

0115 8230248; Matthew.Brook@nottingham.ac.uk

Campbell Menzies

CONTACT

campbell.menzies@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: February 4, 2025
• Study Start: July 29, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

GB (1)