Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07065643

Sex Hormones as Regulators of the Age- and Sex-dependent Benefits of Caloric Restriction

Led by University of Aberdeen · Updated on 2025-07-18

75

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

Sponsors

U

University of Aberdeen

Lead Sponsor

U

University of Edinburgh

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sex Hormones as Regulators of the Age- and Sex-dependent Benefits of Caloric Restriction

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old who are healthy but overweight or obese with a BMI between 27 and 45 kg/m2
  • Women aged 40 or younger
  • Men aged 40 or younger
  • Women aged 55 to 65 years who are in menopause and not taking hormone replacement therapy
  • Men aged 55 to 65 years
  • Women aged 55 to 65 years who are in menopause and have been taking estrogen hormone replacement therapy continuously for 24 months
  • Menopause is defined as no menstrual period for 12 months
Not Eligible

You will not qualify if you...

  • Currently taking weight loss medications (e.g., GLP agonists), beta-blockers, antihistamines, antipsychotics, benzodiazepines, barbiturates, melatonin, Ritalin, modafinil, soporifics, hypnotics, antiepileptic drugs, or diabetes medications
  • Planning to become pregnant, currently pregnant, or breastfeeding
  • Diagnosed with coeliac disease, gluten intolerance, or food allergies
  • Diagnosed with type 1 or type 2 diabetes
  • Suffering from psychiatric disorders or substance abuse
  • Following a vegetarian or vegan diet
  • Currently on a weight loss program affecting lifestyle, physical activity, or diet, or have had gastric band or reduction surgery
  • Currently participating in another research study
  • Have unsuitable veins for blood sampling
  • Unable to fluently speak, read, and understand English
  • Unable to comply with an alcohol-free diet for 6 weeks
  • Unable to give fully informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rowett Institute, University of Aberdeen

Aberdeen, United Kingdom

Actively Recruiting

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Research Team

A

Alexandra M. Johnstone, Professor

CONTACT

M

Marta Lonnie, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

FACTORIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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Sex Hormones as Regulators of the Age- and Sex-dependent Benefits of Caloric Restriction | DecenTrialz