Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion
Primary Purpose
Obesity, Abdominal
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whey Protein
Mixed Macronutrient Breakfast Meal
Mixed Macronutrient Lunch Meal
Sponsored by
About this trial
This is an interventional basic science trial for Obesity, Abdominal focused on measuring Postprandial glycemia, Metabolic health measures
Eligibility Criteria
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
Sites / Locations
- Faculty of Health and Life Sciences, Northumbria University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Experimental
Experimental
Experimental
Arm Label
Non Protein Trial
Preload Trial
With Meal Trial
Post Meal Trial
Arm Description
Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein
Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal
Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal
Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal
Outcomes
Primary Outcome Measures
Postprandial blood glucose responses
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch
Secondary Outcome Measures
Acute subjective appetite responses
Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals
Full Information
NCT ID
NCT02658110
First Posted
January 14, 2016
Last Updated
January 14, 2016
Sponsor
Northumbria University
1. Study Identification
Unique Protocol Identification Number
NCT02658110
Brief Title
Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion
Official Title
Acute Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion in Overweight and Obese Males
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northumbria University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal
Keywords
Postprandial glycemia, Metabolic health measures
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non Protein Trial
Arm Type
Sham Comparator
Arm Description
Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein
Arm Title
Preload Trial
Arm Type
Experimental
Arm Description
Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal
Arm Title
With Meal Trial
Arm Type
Experimental
Arm Description
Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal
Arm Title
Post Meal Trial
Arm Type
Experimental
Arm Description
Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein
Intervention Description
20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
Intervention Type
Other
Intervention Name(s)
Mixed Macronutrient Breakfast Meal
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Mixed Macronutrient Lunch Meal
Intervention Description
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)
Primary Outcome Measure Information:
Title
Postprandial blood glucose responses
Description
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch
Time Frame
0-360 minutes post breakfast
Secondary Outcome Measure Information:
Title
Acute subjective appetite responses
Description
Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals
Time Frame
0-360 minutes post breakfast
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma J Stevenson, PhD
Organizational Affiliation
Northumbria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Health and Life Sciences, Northumbria University
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion
We'll reach out to this number within 24 hrs