About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Factorial
Treatments tested in this trial
Phase 1 - Maintenance Diet
Other intervention3d maintenance diet (MT, fixed macronutrient composition of 15% protein, 30% fat and 55% CHO), fed to energy requirements (1.3 X RMR)
Phase 2 - Weight loss diet
Other intervention6 week calorie restricted high protein diet (CR, fixed macronutrient composition as 30% protein, 35% fat and 35% CHO) fed to energy requirements \[0.8 X Resting Metabolic Rate (RMR)\], with stepwise reduction of 100kcal/d at week 3 and 5
Treatment groups
Trial outcomes
Primary outcomes
Change in body mass expressed as weight in kilograms (kg)
Measured using digital scale
Change in energy expenditure expressed in kilocalories per day (kcal/day)
Measured using stable isotope method - doubly labelled water (DLW) - with urine sample collection
Secondary outcomes
Change in resting metabolic rate (RMR) expressed in kcal/day
Measured using ventilated hood indirect calorimetry
Change in bone mineral content in grams (g)
Measured using Dual Energy X-Ray Absorptiometry (DXA) scan
Change in total body water (TBW) in litres (l)
Measured using deuterium dilution, with urine sample collection
Change in total body density expressed in litres (l)
Measured using BodPod air displacement plethysmography
Other outcomes
Change in glycaemic control in response to caloric restriction diet
Measured with continuous glucose monitoring (CGM) Freestyle Libre
Change in fasting concentration of glucose
Measured from capillary blood from a finger
Change in fasting concentration of ketones
Measured from capillary blood from a finger
Change in fasting concentration of Glucose Ketone Index (GKI)
Calculated from glucose and ketone values
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aberdeen
Lead sponsor
University of Edinburgh
Collaborator