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Metabolic and Appetite Responses to a Whey Protein Preload Following Prior Exercise in Overweight Males

Primary Purpose

Obesity, Abdominal

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whey protein
Mixed macronutrient breakfast meal
Ad libitum lunch meal
Low/moderate intensity exercise
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:

  • Cardiovascular, metabolic or renal disease
  • Current illness
  • Regular breakfast skipper
  • Food allergies or intolerances
  • Eating disorders
  • Smoker
  • Inadequate venous access
  • Taking medication that may affect metabolism

Sites / Locations

  • Faculty of Health and Life Sciences, Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control Trial

Exercise No Preload Trial

Exercise With Preload Trial

Arm Description

A mixed macronutrient breakfast meal is consumed without additional protein, following a period of rest. An ad libitum lunch meal is subsequently consumed.

Following an exercise bout a mixed macronutrient breakfast meal is consumed without additional protein. An ad libitum lunch meal is subsequently consumed.

Following low/moderate intensity exercise bout, whey protein (20g) administered prior to consumption of mixed macronutrient breakfast meal. An ad libitum lunch meal is subsequently consumed.

Outcomes

Primary Outcome Measures

Postprandial blood glucose responses
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast

Secondary Outcome Measures

Energy intake at ad libitum lunch meal
Energy intake is assessed by recording the mass of food (of known composition) ingested during the lunch meal

Full Information

First Posted
March 16, 2016
Last Updated
July 4, 2016
Sponsor
Northumbria University
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1. Study Identification

Unique Protocol Identification Number
NCT02714309
Brief Title
Metabolic and Appetite Responses to a Whey Protein Preload Following Prior Exercise in Overweight Males
Official Title
Acute Metabolic and Second Meal Appetite Responses to a Whey Protein Preload Following Prior Moderate Intensity Exercise in Overweight and Obese Males
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (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
Consuming whey protein may have beneficial effects on health, principally by having an impact on blood glucose metabolism, but also by affecting appetite. The purpose of this project is to investigate the effect of consuming whey protein preload prior to breakfast, following a bout of low/moderate intensity exercise (brisk walking), on glucose and lipids in the blood as well as on appetite. It is hypothesised that the consumption of whey protein before a meal after prior low/moderate intensity exercise may positively affect postprandial handling as well as appetite sensations and consequently reduce intake at a subsequent meal.
Detailed Description
A crossover design shall be implemented, whereby all participants complete 3 experimental trials in random order, separated by a minimum of 5 days. Participants will be asked to record their dietary intake for 24 hours before each trial and will be provided with a standardised meal to consume at a set time the previous evening. At each visit participants shall report to the lab at approximately 08.00 hours following a 12 hour fast and having refrained from caffeine, alcohol and vigorous physical activity for 24 hours. After determination of body mass and stature, a cannula shall be inserted into an antecubital vein in order to collect venous blood samples. A baseline blood sample (10ml) shall be collected, and visual analogue scales (VAS) completed in order to assess appetite sensations. Following this a 30 minute exercise bout shall be completed in two of the trials, with 30 minutes of seated rest carried out in the control trial. Participants shall walk on a motorised treadmill at a predetermined speed designed to reflect 55% of estimated maximal aerobic capacity. Heart rate and perceived exertion will be sampled every three minutes, while expired air shall be sampled for two minute periods at 5, 15 and 25 minutes. During the preload trial, participants shall consume a whey protein beverage 15 minutes after completion of the exercise bout. This will consist of 23g whey protein isolate powder (20g protein) combined with 200ml water and 10 drops of energy-free flavouring to create a milkshake-type beverage. In both other trials an isovolumetric bolus of similarly flavoured water shall be consumed. After a further 15 minutes participants shall consume the same mixed-macronutrient breakfast meal under all conditions, and will subsequently rest for a 240 minute period. An ad libitum pasta meal shall be consumed at the end of this period in all trials in order to assess subsequent energy intake. Regular blood samples shall be collected throughout.

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
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Trial
Arm Type
Experimental
Arm Description
A mixed macronutrient breakfast meal is consumed without additional protein, following a period of rest. An ad libitum lunch meal is subsequently consumed.
Arm Title
Exercise No Preload Trial
Arm Type
Experimental
Arm Description
Following an exercise bout a mixed macronutrient breakfast meal is consumed without additional protein. An ad libitum lunch meal is subsequently consumed.
Arm Title
Exercise With Preload Trial
Arm Type
Experimental
Arm Description
Following low/moderate intensity exercise bout, whey protein (20g) administered prior to consumption of mixed macronutrient breakfast meal. An ad libitum lunch meal is subsequently consumed.
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 kilojoules (kJ); 468 kcal total)
Intervention Type
Other
Intervention Name(s)
Ad libitum lunch meal
Intervention Description
A mixed-macronutrient lunch served to all participants ad libitum. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat
Intervention Type
Other
Intervention Name(s)
Low/moderate intensity exercise
Intervention Description
A 30 minute bout of treadmill walking is performed on a motorised treadmill at a low/moderate intensity (55% estimated VO2max)
Primary Outcome Measure Information:
Title
Postprandial blood glucose responses
Description
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast
Time Frame
0-240 minutes post breakfast
Secondary Outcome Measure Information:
Title
Energy intake at ad libitum lunch meal
Description
Energy intake is assessed by recording the mass of food (of known composition) ingested during the lunch meal
Time Frame
240 minutes post breakfast 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: Cardiovascular, metabolic or renal disease Current illness Regular breakfast skipper Food allergies or intolerances Eating disorders Smoker Inadequate venous access Taking medication that may affect metabolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny L Rumbold, 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
Citations:
PubMed Identifier
32572617
Citation
Allerton DM, West DJ, Stevenson EJ. Whey protein consumption following fasted exercise reduces early postprandial glycaemia in centrally obese males: a randomised controlled trial. Eur J Nutr. 2021 Mar;60(2):999-1011. doi: 10.1007/s00394-020-02304-2. Epub 2020 Jun 22.
Results Reference
derived

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Metabolic and Appetite Responses to a Whey Protein Preload Following Prior Exercise in Overweight Males

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