GendAge weight loss study: sex hormones as regulators of the age- and sex-dependent benefits of caloric restriction

Gender- and age-dependent effects of caloric restriction on body composition, glucose homeostasis, energy balance and adipose metabolism in overweight and obese adults: a controlled dietary intervention study comparing younger and older men and women, with an embedded sub-study examining the role of oestrogen hormone replacement therapy (HRT) in postmenopausal women (GendAge Study)

Registry ID
ISRCTN17589855
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University of Aberdeen
Enrollment
75
Start date
2025-07-09
Completion date
2028-03-31
Last update
2026-08-17

Conditions

Summary

Overweight and/or obesity

Detailed description

Run-in period of 10 days (7 day ad libitum food diary at home and 3 days maintenance diet provided to energy balance). Followed by a weight loss diet for 6 weeks (42days), as a nonrandomised allocation. The study lasts 53 days in total for each participant comprising twenty-two study visits to the Human Intervention Studies Unit (HISU); a screening visit during which potential volunteers will be asked to fill in a health questionnaire at the screening visit to assess their suitability for the study. This is followed by four test day visits (representing pre- and post- dietary phases) and seventeen occasions to collect food and have body weight measured. All food provided to free-living participants is prepared at the HISU by dietetic staff. The study meals are adjusted (scaled) to individual energy requirements based on measured basal energy requirements (RMR – Resting Metabolic Rate). • Phase 1: 3-day maintenance diet (MT, fixed macronutrient composition of 15% protein, 30% fat and 55% CHO), fed to energy requirements (1.3 X RMR) • Phase 2: 6-week calorie restricted weight loss diet (CR, fixed macronutrient composition as 30% protein, 35% fat and 35% CHO) fed to energy requirements (0.8 X RMR), with stepwise reduction of 100kcal/d at week 3 and 5 (Days 15 and 29)

Interventions

Inclusion criteria

Adults (aged over 18years) who are healthy but overweight/obese (BMI 27-45kg/m2): 1. 15 women (age 40 or less years) 2. 15 men (age 40 or less years) 3. 15 women (age 55-65 years) in menopause*; not taking Hormone Replacement Therapy (HRT) 4. 15 men (age 55-65 years) 5. 15 women (age 55-65 years) in menopause; taking HRT** *menopause definition is no menstrual period for 12 months **HRT inclusion criteria - women will have continuously taken oestrogen HRT for 24 months

Exclusion criteria

Medication exclusion criteria, current use: 1. Weight loss medication (e.g. GLP agonists), β-blockers, antihistamines, antipsychotics, benzodiazepines, barbiturates, melatonin, Ritalin, modafinil, soporifics, hypnotics, antiepileptic drugs, diabetes medication (e.g. metformin or insulin). Self-reported medical exclusion criteria: 1. Females who are planning to be pregnant, are pregnant or are breastfeeding 2. Coeliac disease or gluten intolerance or food allergy 3. Diagnosed T1 or T2 diabetes 4. Suffering from a psychiatric disorder or any type of substance abuse Other exclusion criteria: 1. Vegetarian or vegan diet 2. Following a weight loss programme (that may be affecting lifestyle, physical activity & diet) or undergone gastric band/reduction surgery; including GLP agonist (e.g. Semaglutide injection, Ozempic®) 3. Currently participating in another research study 4. Unsuitable veins for blood sampling 5. Unable to fluently speak, read and understand English 6. Unable to comply to an alcohol-free diet for 6 weeks 7. Unable to give fully informed consent

Locations

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