Resistance exercise and nutrition support for transgender women and gender-diverse adults starting estrogen therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional program enrolls adults assigned male at birth who identify as transgender women or gender-diverse and are initiating estrogen-based gender-affirming hormone therapy with androgen suppression. Participants receive a supervised resistance exercise program combined with nutrition and exercise counseling, with baseline and follow-up measures of muscle mass, strength, and function. The protocol targets early changes in appendicular lean mass and muscular performance that could signal increased sarcopenia risk after starting estrogen therapy. Outcomes will compare muscle and functional measures over time between those receiving the intervention and expected changes from prior cohorts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 18 years
* Initiating or within 3 months or less of initiating GAHT with estradiol (oral, sublingual, patch, injection) AND androgen suppression (leuprolide, spironolactone or bicalutamide)
* Identifies as either a transgender female/woman, gender-diverse, non-binary, gender non-confirming, gender-fluid, and/or gender-queer
* Assigned male sex at birth

Exclusion Criteria:

* Current condition(s) which may preclude the ability to participate in a resistance exercise program (including but not limited to conditions which may significantly impair mobility and balance)
* Current condition(s) where resistance exercise program may be contraindicated (including but not limited to decompensated heart failure, unstable ischemic heart disease, pulmonary hypertension, aortic aneurysm, moderate to severe valvopathies, and/or moderate to severe chronic respiratory insufficiency)
* Use of testosterone therapy for \> 1 month in the last 6 months
* Use of gender-affirming hormone therapy with androgen/testosterone suppression and/or estradiol therapy within 1 year of enrollment
* Use of gender-affirming hormone therapy with androgen/testosterone suppression and/or estradiol therapy for \> 1 year at any time period prior to enrollment
* History of an orchiectomy
* Current resistance exercise (including but not limited to use of resistance bands, suspension equipment, body weight exercise, free weight exercise) of 60 minutes or greater per week
* Enrollment in another study that the study investigators deem as potentially interfering with study participants or study endpoints

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Mabel Toribio, MD
• Email: mptoribio@mgh.harvard.edu
• Phone: 617-724-2826

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Protein supplements with or without spices to protect muscle for people on GLP-1 weight loss meds

  This pilot test checks whether daily whey protein, with or without mixed spices, helps preserve muscle mass and strength in adults using GLP-1 weight-loss medicines.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07806838

• Estrogen status and muscle health in aging women before and after menopause

  This study tests how estrogen levels relate to muscle size, strength, and function in women around menopause.

  Recruiting University of Aarhus · Aarhus · NCT07649356

• Keeping muscle and strength during tirzepatide weight loss with resistance exercise

  This program will test whether adding a progressive resistance exercise program to tirzepatide helps overweight or obese women aged 25–50 keep muscle and physical function while losing weight.

  Recruiting University of Exeter · Exeter, Devon · NCT07457437

• Robotic upper-limb rehab vs standard therapy for adults with tetraplegia

  This study tests whether a robotic arm rehabilitation device (PABLO®) plus standard therapy helps people with tetraplegia recover more upper-limb strength than standard rehab alone.

  Recruiting IRCCS Sacro Cuore Don Calabria di Negrar · Negrar, Veneto · NCT07860827

• Electrical muscle stimulation plus resistance training for trained weightlifters

  This study will test whether adding electrical muscle stimulation (EMS) to regular resistance training helps trained male weightlifters gain more muscle, strength, power, and improved body composition over eight weeks.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07484646

• MediDrink Platinum+ with a new fava bean protein and optional PeptiStrong to improve fitness in older adults with sarcopenia

  This trial will see if MediDrink Platinum+ with a novel protein blend, given alone or together with PeptiStrong, improves fitness in malnourished adults aged 60 and older who have sarcopenia.

  Recruiting at 2 sites Nuritas Ltd · Budapest and 1 other locations · NCT07322653

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.