What this trial studies
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.
Conditions in scope
- Overweight and Obese Adults
- Healthy
Interventions
- 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)
- 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
Who can join
All sexes · Ages 18 Years to 65 Years · Accepts healthy volunteers.
Inclusion criteria
- Adults (aged over 18years) who are healthy but overweight/obese (BMI 27-45kg/m2) males and females as:
- women (age 40 or less years)
- men (age 40 or less years)
- women (age 55-65 years) in menopause*; not taking Hormone Replacement Therapy (HRT)
- men (age 55-65 years)
- 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.
- 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).
- 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
- Anyone following a vegetarian or vegan diet
- Anyone currently following a weight loss programme (that may be affecting lifestyle, physical activity \& diet) or undergone gastric band/reduction surgery; including GLP agonist (e.g. Semaglutide injection, Ozempic®).
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Aberdeen | Rowett Institute, University of Aberdeen | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2025-07-09
- Primary completion: 2027-12
- Last update posted: 2025-07-18
- First posted: 2025-07-15
Sponsor & contact
Lead sponsor: University of Aberdeen (Other)
Collaborators: University of Edinburgh
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Change in body mass expressed as weight in kilograms (kg) (From baseline (day 1) to end of intervention (day 53); additional measurements taken three times a week throughout the intervention duration)
Measured using digital scale - Change in energy expenditure expressed in kilocalories per day (kcal/day) (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)
Measured using stable isotope method - doubly labelled water (DLW) - with urine sample collection
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07065643 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.