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| ID | Type | Description | Link |
|---|---|---|---|
| 2-034-25 | Other Grant/Funding Number | Medical Research Council (MRC) |
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| Name | Class |
|---|---|
| University of Edinburgh | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young women | Experimental | Age: 18 to 40 years old |
|
| Young men | Active Comparator | Age: 18 to 40 years old |
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| Older women (menopause & no-HRT) | Experimental | Age 55-65 years, in menopause, not taking Hormonal Replacement Therapy (HRT) |
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| Older women (menopause & HRT) | Experimental | Age 55-65 years, in menopause, who have continuously taken oestrogen HRT for 24 months |
|
| Older men | Active Comparator | Age 55-65 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1 - Maintenance Diet | Other | 3d maintenance diet (MT, fixed macronutrient composition of 15% protein, 30% fat and 55% CHO), fed to energy requirements (1.3 X RMR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass expressed as weight in kilograms (kg) | Measured using digital scale | From baseline (day 1) to end of intervention (day 53); additional measurements taken three times a week throughout the intervention duration |
| Change in energy expenditure expressed in kilocalories per day (kcal/day) | Measured using stable isotope method - doubly labelled water (DLW) - with urine sample collection | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in resting metabolic rate (RMR) expressed in kcal/day | Measured using ventilated hood indirect calorimetry | From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in bone mineral content in grams (g) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycaemic control in response to caloric restriction diet | Measured with continuous glucose monitoring (CGM) Freestyle Libre | Every day of the study (days 1-53) |
| Change in fasting concentration of glucose |
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**
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:
Other exclusion criteria
Only biological (cisgender) males and females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra M. Johnstone, Professor | Contact | 01224 438614 | alex.johnstone@abdn.ac.uk | |
| Marta Lonnie, Dr | Contact | gendage@abdn.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra M Johnstone, Professor | Rowett Institute, University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rowett Institute, University of Aberdeen | Recruiting | Aberdeen | United Kingdom |
The study will be registered with ClinicalTrials.gov as a data repository. Links to IPD that underlie results in publications will be made available at the appropriate time through the project team's website which will contain a summary of the data compiled.
Data will be shared with the academic community once this has been published in open access journals
Open access from the project's website to IPD that underline the results reported in scientific publications.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Phase 2 - Weight loss diet | Other | 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 |
|
Measured using Dual Energy X-Ray Absorptiometry (DXA) scan
| From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in total body water (TBW) in litres (l) | Measured using deuterium dilution, with urine sample collection | From day 11 (start of the calorie-restricted diet) to end of the intervention (day 53) |
| Change in total body density expressed in litres (l) | Measured using BodPod air displacement plethysmography | From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in body fat-mass percentage (%) | Derived from Lohman's 4-compartment model (body mass; body density; total body water; and bone mineral content) | From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in non-esterified fatty acids (NEFA) concentration in fasted blood sample | Analysed by KONE | From day 8 (start of the maintenance diet) to end of the intervention (day 53); also measured at midpoint of calorie-restricted diet (day 32) |
| Change in concentration of caloric-restriction (CR) related hormones in fasted blood sample | Includes: leptin, adiponectin, cortisol; analysed by ELISA | From day 8 (start of the maintenance diet) to end of the intervention (day 53); also measured at midpoint of calorie restricted diet (day 32) |
| Change in sex hormones concentration in fasted blood sample | Includes: oestrogens, progesterone, androgens; analysed by high -sensitivity liquid chromatography-mass spectrometry (LC-MS) | From day 8 (start of the maintenance diet) to end of the intervention (day 53); also measured at midpoint of calorie restricted diet (day 32) |
| Body height measured in meters (m) | Measured using stadiometer | Only at baseline |
| Change in Body Mass Index (BMI) expressed as kg/m^2 | BMI will be calculated using weight and height measures | From baseline (day 1) to end of intervention (day 53); additional measurements taken three times a week throughout the intervention duration |
| Change in adipose tissue metabolism assessed by adipocite size | Measured via abdominal subcutaneous fat biopsy using fine needle aspiration and histomorphometry method | From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in adipose tissue metabolism assessed by phosphorylation of hormone-sensitive lipase (HSL) | Measured via abdominal subcutaneous fat biopsy using fine needle aspiration and immunoblotting method. | From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
Measured from capillary blood from a finger
| From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in fasting concentration of ketones | Measured from capillary blood from a finger | From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in fasting concentration of Glucose Ketone Index (GKI) | Calculated from glucose and ketone values | From day 8 (start of the maintenance diet) to end of the intervention (day 53) |
| Change in levels of physical activity (PA) expressed as energy expenditure (kcal/day) | Actigraph wearable device for recording physical activity via accelerometery method | Every day of the study (days 1-53) |
| Change in physical activity intensity expressed as minutes spent on Moderate to vigorous (MVPA) per day | Measured accelerometry (with Actigraph wearable device) and calculated using energy expenditure and time spent in MVPA | Every day of the study (days 1-53) |
| Change in food intake | Measured using weighted intake record | Starting from ad libitum intake (days 1-7) and every day of the study diets (day 8-52) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |