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

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ClinicalTrials.gov Identifier: NCT02714309
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Northumbria University

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE March 21, 2016
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE March 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
Postprandial blood glucose responses [ Time Frame: 0-240 minutes post breakfast ]
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic and Appetite Responses to a Whey Protein Preload Following Prior Exercise in Overweight Males
Official Title  ICMJE Acute Metabolic and Second Meal Appetite Responses to a Whey Protein Preload Following Prior Moderate Intensity Exercise in Overweight and Obese Males
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Obesity, Abdominal
Intervention  ICMJE
  • Dietary Supplement: Whey protein
    20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
  • 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)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Mixed macronutrient breakfast meal
    • Other: Ad libitum lunch meal
  • 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.
    Interventions:
    • Other: Mixed macronutrient breakfast meal
    • Other: Ad libitum lunch meal
    • Other: Low/moderate intensity exercise
  • 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.
    Interventions:
    • Dietary Supplement: Whey protein
    • Other: Mixed macronutrient breakfast meal
    • Other: Ad libitum lunch meal
    • Other: Low/moderate intensity exercise
Publications * 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. 2020 Jun 22. doi: 10.1007/s00394-020-02304-2. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
13
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714309
Other Study ID Numbers  ICMJE HLSDA190116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northumbria University
Study Sponsor  ICMJE Northumbria University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Penny L Rumbold, PhD Northumbria University
PRS Account Northumbria University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP