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

July 4, 2016 updated by: Northumbria University

Acute Metabolic and Second Meal Appetite Responses to a Whey Protein Preload Following Prior Moderate Intensity Exercise in Overweight and Obese Males

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
        • Faculty of Health and Life Sciences, Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Trial
A mixed macronutrient breakfast meal is consumed without additional protein, following a period of rest. An ad libitum lunch meal is subsequently consumed.
Other: Mixed macronutrient breakfast meal
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)
Other: Ad libitum lunch meal
A mixed-macronutrient lunch served to all participants ad libitum. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat
Experimental: Exercise No Preload Trial
Following an exercise bout a mixed macronutrient breakfast meal is consumed without additional protein. An ad libitum lunch meal is subsequently consumed.
Other: Mixed macronutrient breakfast meal
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)
Other: Ad libitum lunch meal
A mixed-macronutrient lunch served to all participants ad libitum. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat
Other: Low/moderate intensity exercise
A 30 minute bout of treadmill walking is performed on a motorised treadmill at a low/moderate intensity (55% estimated VO2max)
Experimental: Exercise With Preload Trial
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.
Other: Mixed macronutrient breakfast meal
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)
Other: Ad libitum lunch meal
A mixed-macronutrient lunch served to all participants ad libitum. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat
Other: Low/moderate intensity exercise
A 30 minute bout of treadmill walking is performed on a motorised treadmill at a low/moderate intensity (55% estimated VO2max)
Dietary supplement: Whey protein
20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial blood glucose responses
Time Frame: 0-240 minutes post breakfast
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast
0-240 minutes post breakfast

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy intake at ad libitum lunch meal
Time Frame: 240 minutes post breakfast breakfast
Energy intake is assessed by recording the mass of food (of known composition) ingested during the lunch meal
240 minutes post breakfast breakfast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Investigators

  • Study Director: Penny L Rumbold, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLSDA190116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity, Abdominal

Clinical Trials on Mixed macronutrient breakfast meal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe