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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Aberdeen

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • Phase 1 - Maintenance Diet

    Other intervention

    3d 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 intervention

    6 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

75 Participants
are divided into 5 treatment groups
Group A: Young womenExperimental treatment 2 interventions
Group B: Young menActive comparator 2 interventions
Group C: Older women (menopause & no-HRT)Experimental treatment 2 interventions
Group D: Older women (menopause & HRT)Experimental treatment 2 interventions
Group E: Older menActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in body mass expressed as weight in kilograms (kg)

Measured using digital scale

Time frame
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)

Measured using stable isotope method - doubly labelled water (DLW) - with urine sample collection

Time frame
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

Secondary outcomes

1

Change in resting metabolic rate (RMR) expressed in kcal/day

Measured using ventilated hood indirect calorimetry

Time frame
From day 8 (start of the maintenance diet) to end of the intervention (day 53)
2

Change in bone mineral content in grams (g)

Measured using Dual Energy X-Ray Absorptiometry (DXA) scan

Time frame
From day 8 (start of the maintenance diet) to end of the intervention (day 53)
3

Change in total body water (TBW) in litres (l)

Measured using deuterium dilution, with urine sample collection

Time frame
From day 11 (start of the calorie-restricted diet) to end of the intervention (day 53)
4

Change in total body density expressed in litres (l)

Measured using BodPod air displacement plethysmography

Time frame
From day 8 (start of the maintenance diet) to end of the intervention (day 53)

Other outcomes

1

Change in glycaemic control in response to caloric restriction diet

Measured with continuous glucose monitoring (CGM) Freestyle Libre

Time frame
Every day of the study (days 1-53)
2

Change in fasting concentration of glucose

Measured from capillary blood from a finger

Time frame
From day 8 (start of the maintenance diet) to end of the intervention (day 53)
3

Change in fasting concentration of ketones

Measured from capillary blood from a finger

Time frame
From day 8 (start of the maintenance diet) to end of the intervention (day 53)
4

Change in fasting concentration of Glucose Ketone Index (GKI)

Calculated from glucose and ketone values

Time frame
From day 8 (start of the maintenance diet) to end of the intervention (day 53)

Sponsors and contacts

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University of Aberdeen

Lead sponsor

University of Edinburgh

Collaborator