An interventional study of Whey Protein and Mixed Macronutrient Breakfast Meal in Obesity, Abdominal, sponsored by Northumbria University. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-01-18.
Sponsored by Northumbria University · Not applicable, Interventional, and Basic science
The proposed study aims to determine the metabolic and appetite responses to standard breakfast and lunch meals whilst altering the timing of whey protein supplementation. Currently, the designs implemented in many studies mean that it is unclear whether an optimum time for whey protein consumption exists in order to promote the greatest acute health benefits. A number of studies have investigated the effects of whey protein when consumed as a preload to a subsequent meal, whilst benefits have also been shown when whey protein is ingested with a meal. The proposed study will therefore investigate strategies of whey protein supplementation that vary in their practical applicability, using meals that reflect regular eating behaviours throughout the population in a sample of overweight/obese individuals.
Findings from this study may provide important information regarding the efficacy of whey protein supplementation before, during and after a composite meal, and its effect on the handling of a subsequent mixed-macronutrient meal.
A randomised crossover design shall be implemented, whereby all participants complete 4 trials separated by a minimum of 3 days. On all visits participants shall consume a standardised mixed-macronutrient breakfast meal, followed 180 minutes later by consumption of a standard lunch meal. The timing of additional protein supplementation shall vary by trial, with participants consuming a shake containing 20g whey protein isolate either as a preload (15 minutes prior to breakfast), alongside the breakfast meal, or 15 minutes following breakfast consumption. A control trial shall also be completed without additional protein supplementation. At all supplementation time points participants shall consume either a flavoured whey protein shake or a flavoured water isovolumetric beverage ensuring that they remain blinded to the condition. Venous and capillary blood samples and visual analogue scales (for determination of subjective appetite sensations) shall be taken at regular intervals following both meals while the participant is rested.
274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.
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Criteria for inclusion are as follows:
Criteria for exclusion are as follows:
Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein
Other: Mixed Macronutrient Breakfast Meal · Other: Mixed Macronutrient Lunch Meal
Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal
Dietary Supplement: Whey Protein · Other: Mixed Macronutrient Breakfast Meal · Other: Mixed Macronutrient Lunch Meal
Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal
Dietary Supplement: Whey Protein · Other: Mixed Macronutrient Breakfast Meal · Other: Mixed Macronutrient Lunch Meal
Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal
Dietary Supplement: Whey Protein · Other: Mixed Macronutrient Breakfast Meal · Other: Mixed Macronutrient Lunch Meal
20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
A standardised mixed-macronutrient breakfast served to all participants. The macronutrient distribution of the breakfast is 13% protein, 70% carbohydrate, 17% fat (1958 kJ; 468 kcal total)
A standardised mixed-macronutrient lunch served to all participants. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat (3506 kJ; 838 kcal total)
Postprandial blood glucose responses
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch
Time frame: 0-360 minutes post breakfast
Acute subjective appetite responses
Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals
Time frame: 0-360 minutes post breakfast
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Northumbria University