Central obesity and lean Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Lean: 1. Aged between 18 – 65 years 2. BMI of 18 - 25 kg.m2 3. Weight stable for > 2 months (± 1kg) preceding the commencement of the intervention 4. Physically active as assessed by the International Physical Activity Questionnaire 5. Adhere to a normal wake/sleep cycle (i.e. non-shift workers) 6. Regularly consume breakfast Centrally obese: 1. Aged between 18 – 65 years 2. BMI > 30 kg.m2 or waist circumference of > 102 cm 3. Weight stable for > 2 months (± 1kg) preceding the commencement of the intervention 4. Physical inactive as assessed by the International Physical Activity Questionnaire 5. Adhere to a normal wake/sleep cycle (i.e. non-shift workers) 6. Regularly consume breakfast
Exclusion criteria
Exclusion criteria: 1. History of metabolic or cardiovascular diseases 2. Taking medicines that may influence gut function or satiety 3. Smokers 4. Gastrointestinal issues 5. Known food intolerance's or allergies 6. Substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glycaemic responses (incremental area under the curve [iAUC]) to a mixed-nutrient breakfast following prior consumption of the protein-rich supplement and control beverage (i.e. “pre-load”). Glycaemic responses will be measured from venous whole blood samples over a 4-hour postprandial period. Postprandial glycaemic responses will be calculated using the trapezoidal rule and broken down into epochs depicting different stages of the postprandial period – i.e. 0-60 min (early), 120-240 min (late) and 0-240 min (total). Glucose concentrations will be determined using a commercially available assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of gastric emptying (iAUC) following prior consumption of the whey protein beverage compared to the control drink will be determined by pharmacokinetics of plasma acetaminophen concentrations [visits 2 and 4]. Postprandial acetaminophen responses will be calculated using the trapezoidal rule and broken down into epochs depicting different stages of the postprandial period – i.e. 0-60min (early), 120-240min (late) and 0-240min (total). Acetaminophen concentrations will be determined using a commercially available assay. 2. Time-course changes in subjective appetite sensations measured using a 100 mm paper-based linear visual analogue scale during the mixed meal tolerance tests [visits 2, and 4] – i.e. baseline, pre-meal, and 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min post-meal. 3. Time-course responses in blood glucose, acetaminophen and gut hormones following a standardised mixed-nutrient breakfast meal – i.e. baseline, pre-meal, and 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min post-meal [visits 2 and 4]. All markers will be analysed by routinely available assays. 4. The influence of adiposity on the efficacy of whey protein. A regression analysis will be performed on pooled data [visits 2 and 4] from both cohorts (lean and centrally obese) to determine if there are any markers of adiposity (weight, BMI, waist circumference and waist-to-hip ratio) that predict the glucose-lowering properties of whey protein (i.e. magnitude of change in plasma glucose concentrations from fasting levels). | — |
Countries
England, United Kingdom
Contacts
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