Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Acute Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion in Overweight and Obese Males

Conditions
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Obesity, Abdominal

Intervention / Treatment
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* Dietary Supplement: Whey Protein
* Other: Mixed Macronutrient Breakfast Meal
* Other: Mixed Macronutrient Lunch Meal


Participation Criteria
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Eligibility Criteria
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Criteria for inclusion are as follows: Male Aged 18-55 years Abdominal obesity (Waist circumference > 102 cm) Sedentary (not currently participating in structured physical activity) Criteria for exclusion are as follows: Metabolic disease or current illness Regular breakfast skipper Food allergies/intolerances Eating disorders Smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Non Protein Trial<br>Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein | Other: Mixed Macronutrient Breakfast Meal<br>* 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)<br>Other: Mixed Macronutrient Lunch Meal<br>* 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)<br>|
| Experimental: Preload Trial<br>Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal | Dietary Supplement: Whey Protein<br>* 20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage<br>Other: Mixed Macronutrient Breakfast Meal<br>* 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)<br>Other: Mixed Macronutrient Lunch Meal<br>* 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)<br>|
| Experimental: With Meal Trial<br>Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal | Dietary Supplement: Whey Protein<br>* 20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage<br>Other: Mixed Macronutrient Breakfast Meal<br>* 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)<br>Other: Mixed Macronutrient Lunch Meal<br>* 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)<br>|
| Experimental: Post Meal Trial<br>Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal | Dietary Supplement: Whey Protein<br>* 20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage<br>Other: Mixed Macronutrient Breakfast Meal<br>* 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)<br>Other: Mixed Macronutrient Lunch Meal<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial blood glucose responses | Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch | 0-360 minutes post breakfast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute subjective appetite responses | Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals | 0-360 minutes post breakfast | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial glycemia, Metabolic health measures