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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

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.


Condition or disease Intervention/treatment Phase
Obesity, Abdominal Dietary Supplement: Whey protein Other: Mixed macronutrient breakfast meal Other: Ad libitum lunch meal Other: Low/moderate intensity exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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 Start Date : March 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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.
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)




Primary Outcome Measures :
  1. Postprandial blood glucose responses [ Time Frame: 0-240 minutes post breakfast ]
    Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714309


Locations
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United Kingdom
Faculty of Health and Life Sciences, Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
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Study Director: Penny L Rumbold, PhD Northumbria University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT02714309    
Other Study ID Numbers: HLSDA190116
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Northumbria University:
Postprandial glycemia
Metabolic health measures
Additional relevant MeSH terms:
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Obesity, Abdominal
Overweight
Body Weight
Obesity
Overnutrition
Nutrition Disorders
Nutrients
Growth Substances
Physiological Effects of Drugs