Overweight and obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will be stratified by body mass index (23.0-24.9, 25.0-29.9, 30-40 kg/m²) and biological sex (Male/Female). Individuals in each of the 6 stratified groups will then be randomised using bl
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and female participants, 2. Age: 18-55 years, 3. BMI: 23 to 40 kg/m² (verified in the laboratory), 4. Healthy as determined from self-reported medical history or when no relevant medical condition exists, 5. Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements, 6. For female participants: continued use of contraceptive methods during the study or not planning to become pregnant for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. BMI = 22.9 kg/m² or < 40.0 kg/m², 2. Stage 2 hypertension or above (=160/100 mmHg), 3. Alcohol or drug dependency, 4. Medication or supplement use known to affect appetite, body weight/composition, or metabolism within the past month and/or during the study, 5. Present contraindications for dual energy x-ray absorptiometry (DXA) scans or unwilling to undertake DXA scans, 6. Pregnant or breastfeeding in the previous 3 months, or planning to become pregnant, 7. History of anaphylaxis to food, 8. Food allergy, intolerance, restriction or avoidance of any of the study foods 9. Participants with vegan or gluten-free dietary needs. 10. Smokers (including nicotine containing vapes) and those who have recently ceased smoking (<6 months), 11. Volunteers having lost significant amount of weight in the previous 3 months (±3kg) 12. Participants who do night or late shift work (ending later than 11pm) on a permanent basis, 13. Persons who do not have access to mobile phone and the internet (this is necessary for data collection during the study). 14. Self-reported or clinically diagnosed eating disorders, including binge eating (or a history of), 15. Diagnosed anaemia, 16. Hepatic or renal impairments (contraindications for following a very low energy/total meal replacement diet), 17. Diagnosed diabetes mellitus, 18. Hyperthyroidism or hypothyroidism, 19. Abnormal gastro-intestinal function or structure such as malformation, angiodysplasia, active peptic ulcer, 20. Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption, 21. History of gastro-intestinal surgery with permanent effect (i.e. surgical treatment of obesity), 22. Medical history of CVD (e.g. current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease), 23. Significant liver disease, e.g. cirrhosis (fatty liver disease allowed), 24. Pre-existing injuries or medical conditions that could be aggravated by physical activity or exercise, 25. Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed), 26. Psychiatric illness (e.g. clinical depression, bipolar disorders). 27. Individuals who perform structured exercise bouts for 30 minutes or more four or more days per week or have significantly changed their physical activity patterns in the past three months. 28. High-risk occupation for drowsy driving (e.g. commercial truck driver or airline pilot), 29. Diagnosis of a sleep disorder other than obstructive sleep apnoea (e.g. periodic limb movement disorder), 30. Predominantly central sleep apnoea or requiring oxygen or bi-level positive airway pressure or advanced positive airway pressure modalities during periods of sleep, 31. Co-existing hypoventilation (e.g. documented hypercarbia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body composition (body mass, fat mass, and fat-free mass) and the composition of weight loss (percentage fat and fat-free mass loss; fat to fat-free mass ratio) using dual x-ray absorptiometry at baseline, following weight loss, and weight maintenance. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body composition (body mass, fat mass, fat-free mass) and the composition of weight loss (percentage fat and fat-free mass loss; fat to fat-free mass ratio) using a 4-compartmental body composition at baseline and following weight loss. 2. MRI derived organ and tissue mass (heart, liver, kidney, brain, skeletal muscle, and adipose tissue) at baseline and following weight loss. 3. Fasted and area under the curve (AUC-5 – 210 and iAUC-5 – 210) composite visual analogue subjective appetite scores at baseline, following weight loss, and weight loss maintenance. 3. Energy intake at an ad libitum laboratory test meal and self-reported total daily energy intake at baseline, following weight loss, and weight maintenance. 4. Fasted and area under the curve (AUC-5 – 180 and iAUC-5 – 180) concentrations in glucose, insulin, acyl ghrelin, liver-expressed antimicrobial peptide 2 (LEAP2), glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), and cholecystokinin (CCK) at baseline, following weight loss, and weight loss maintenance. 5. Total daily energy expenditure, resting metabolic rate, and adaptive thermogenesis as assessed using indirect calorimetry; and free-living physical activity energy expenditure as assessed using accelerometer at baseline, following weight loss, and weight loss maintenance. 6. Device measured sedentary behaviours (time spent sedentary, standing, sitting, lying down), steps per day, and minutes of physical activity per day (MVPA) at baseline, following weight loss, and weight loss maintenance. 7. State motivations to eat (reactive eating, restricted eating, negative emotional eating, positive emotional eating, homeostatic eating, eating for pleasure, and eating for health) as assessed using ecological momentary assessment at baseline, during weight loss, following weight loss, and weight loss maintenance. 8. Trait eating behaviours and motivations to eat (Motivations for Eating Profile, Three Factor Eating Questionnaire, Intuitive Eating | — |
Countries
England, United Kingdom
Contacts
Public ContactMark Hopkins
Outcome results
None listed