Sex Hormones as Regulators of the Age- and Sex-dependent Benefits of Caloric Restriction (NCT07065643) | Clinical Trial Compass
RecruitingNot Applicable
Sex Hormones as Regulators of the Age- and Sex-dependent Benefits of Caloric Restriction
United Kingdom75 participantsStarted 2025-07-09
Plain-language summary
Obesity increases the risk of type 2 diabetes, cardiovascular disease, and certain cancers, primarily due to elevated abdominal fat storage. With nearly two-thirds of the UK population living with overweight or obesity, there is an urgent necessity for evidence-based public health guidance to promote healthy weight. Calorie deficit can facilitate weight loss and body fat reduction, leading to health benefits, such as improved blood glucose control. Current weight management advice centres on lifestyle modification, incorporating changes to diet and physical activity to support a calorie deficit. However, existing dieting recommendations fail to consider gender or age. This is a surprising oversight, as it is well established that health outcomes vary significantly between men and women across the lifespan. Further, the menopause may have an impact on fat storage linked to changes in sex hormones. Our recent research, involving both mice and humans, has indicated that females are less responsive to weight loss and fat reduction during dieting. This study aims to understand endocrine and metabolic sex-based differences in obesity and calorie restriction, with a particular focus on women's health. We plan to conduct a diet study with 75 participants, encompassing both younger and older men and women, to monitor changes in energy expenditure and body composition using gold-standard techniques, such as doubly-labelled water. Blood and abdominal fat tissue samples will be collected to investigate how sex hormones might elucidate these differences. The aim of the study is to enhance our understanding of diet and women's health to combat obesity and promote healthy ageing.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Adults (aged over 18years) who are healthy but overweight/obese (BMI 27-45kg/m2) males and females as:
* 15 women (age 40 or less years)
* 15 men (age 40 or less years)
* 15 women (age 55-65 years) in menopause\*; not taking Hormone Replacement Therapy (HRT)
* 15 men (age 55-65 years)
* 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:
Potential volunteers will be asked to fill in a health questionnaire at the screening visit to assess their suitability for the study. This information will allow us to exclude participants.
Medication exclusion criteria, current use :-
• 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:
* Females who are planning to be pregnant, are pregnant or are breastfeeding
* Anyone with coeliac disease or gluten intolerance or food allergy
* Anyone with diagnosed T1 or T2 diabetes
* Anyone suffering from a psychiatric disorder or any type of substance abuse
Other exclusion criteria
* Anyone following a vegetarian or vegan diet
* Anyone currently following a weight loss programme (that may be affecting lifestyle, phys…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in body mass expressed as weight in kilograms (kg)
Timeframe: From baseline (day 1) to end of intervention (day 53); additional measurements taken three times a week throughout the intervention duration
2
Change in energy expenditure expressed in kilocalories per day (kcal/day)
Timeframe: From day 11 (start of the calorie-restricted diet) to the end of the intervention (day 52); with additional doses consumed on day 25 and 39