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Completed

NCT Number: NCT02714309

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

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Key information

Conditions

Obesity, Abdominal Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health and Life Sciences, Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

Dietary Supplement

20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage

Mixed macronutrient breakfast meal

Other

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)

Ad libitum lunch meal

Other

A mixed-macronutrient lunch served to all participants ad libitum. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat

Low/moderate intensity exercise

Other

A 30 minute bout of treadmill walking is performed on a motorised treadmill at a low/moderate intensity (55% estimated VO2max)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2016
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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