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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02714309
Other study ID # HLSDA190116
Secondary ID
Status Completed
Phase N/A
First received March 16, 2016
Last updated July 4, 2016
Start date March 2016
Est. completion date July 2016

Study information

Verified date July 2016
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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)
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
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)

Locations

Country Name City State
United Kingdom Faculty of Health and Life Sciences, Northumbria University Newcastle upon Tyne Tyne and Wear

Sponsors (1)

Lead Sponsor Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial blood glucose responses Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast 0-240 minutes post breakfast No
Secondary 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 240 minutes post breakfast breakfast No
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