Diet/inactivity/obesity-related diabetes and associated cardiovascular disease Nutritional, Metabolic, Endocrine Obesity-related diabetes
Conditions
Interventions
Intervention: 6-week daily consumption of breakfast (i.e. at least 2933 kJ before 11:00)
Control: 6-week daily omission of breakfast (i.e. 0 kJ until 12:00)
Sponsors
University of Bath (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants may be male or female (females may or may not be taking oral contraceptives but must maintain a record of menstrual cycle phase or contraceptive use prior to entry into the study) 2. Those within the specified age range (20 - 60 years) 3. Individuals with a body mass index between 20 - 24 kg/m2 or above 30 kg/m2 4. Able and willing to safely comply with all study procedures 5. Able to provide written informed consent for participation whilst acknowledging their freedom to withdraw at any point during the study
Exclusion criteria
Exclusion criteria: 1. Women who are known to be pregnant or who are intending to become pregnant over the course of the study 2. Women who are breast feeding 3. Participation in another clinical trial 4. Any reported use of substances which may pose undue personal risk to participants or introduce bias into the experiment 5. Any other condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias into the experiment 6. Individuals with any known bleeding disorder 7. Individuals currently taking any medication known to act as an anticoagulant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alterations in energy balance between treatments (i.e. the culmination of resting metabolic rate, diet-induced thermogenesis and physical activity energy expenditure relative to dietary energy intake). All measurements contributing to both the primary and secondary outcomes are made throughout two 8 hour lab visits during Phase I and then continuously throughout the first and sixth week of dietary intervention during Phase II. | — |
Secondary
| Measure | Time frame |
|---|---|
| Both the mechanistic data explaining how the intervention may have impacted on energy balance (i.e. appetite regulatory hormones, metabolic regulatory hormones and associated expression of key genes) and also the whole-body endpoints indicative of altered health status with each treatment (i.e. adiposity, glycaemic control and chronic lowgrade inflammation). All measurements contributing to both the primary and secondary outcomes are made throughout two 8 hour lab visits during Phase I and then continuously throughout the first and sixth week of dietary intervention during Phase II. | — |
Countries
United Kingdom
Outcome results
None listed