search
Back to results

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
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity, Abdominal focused on measuring Postprandial glycemia, Metabolic health measures

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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

First Posted
January 14, 2016
Last Updated
January 14, 2016
Sponsor
Northumbria University
search

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