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Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion

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ClinicalTrials.gov Identifier: NCT02658110
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Northumbria University

Brief Summary:

The proposed study aims to determine the metabolic and appetite responses to standard breakfast and lunch meals whilst altering the timing of whey protein supplementation. Currently, the designs implemented in many studies mean that it is unclear whether an optimum time for whey protein consumption exists in order to promote the greatest acute health benefits. A number of studies have investigated the effects of whey protein when consumed as a preload to a subsequent meal, whilst benefits have also been shown when whey protein is ingested with a meal. The proposed study will therefore investigate strategies of whey protein supplementation that vary in their practical applicability, using meals that reflect regular eating behaviours throughout the population in a sample of overweight/obese individuals.

Findings from this study may provide important information regarding the efficacy of whey protein supplementation before, during and after a composite meal, and its effect on the handling of a subsequent mixed-macronutrient meal.


Condition or disease Intervention/treatment Phase
Obesity, Abdominal Dietary Supplement: Whey Protein Other: Mixed Macronutrient Breakfast Meal Other: Mixed Macronutrient Lunch Meal Not Applicable

Detailed Description:
A randomised crossover design shall be implemented, whereby all participants complete 4 trials separated by a minimum of 3 days. On all visits participants shall consume a standardised mixed-macronutrient breakfast meal, followed 180 minutes later by consumption of a standard lunch meal. The timing of additional protein supplementation shall vary by trial, with participants consuming a shake containing 20g whey protein isolate either as a preload (15 minutes prior to breakfast), alongside the breakfast meal, or 15 minutes following breakfast consumption. A control trial shall also be completed without additional protein supplementation. At all supplementation time points participants shall consume either a flavoured whey protein shake or a flavoured water isovolumetric beverage ensuring that they remain blinded to the condition. Venous and capillary blood samples and visual analogue scales (for determination of subjective appetite sensations) shall be taken at regular intervals following both meals while the participant is rested.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Acute Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion in Overweight and Obese Males
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Sham Comparator: Non Protein Trial
Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein
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 kJ; 468 kcal total)

Other: Mixed Macronutrient Lunch Meal
A standardised mixed-macronutrient lunch served to all participants. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat (3506 kJ; 838 kcal total)

Experimental: Preload Trial
Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal
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 kJ; 468 kcal total)

Other: Mixed Macronutrient Lunch Meal
A standardised mixed-macronutrient lunch served to all participants. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat (3506 kJ; 838 kcal total)

Experimental: With Meal Trial
Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal
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 kJ; 468 kcal total)

Other: Mixed Macronutrient Lunch Meal
A standardised mixed-macronutrient lunch served to all participants. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat (3506 kJ; 838 kcal total)

Experimental: Post Meal Trial
Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal
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 kJ; 468 kcal total)

Other: Mixed Macronutrient Lunch Meal
A standardised mixed-macronutrient lunch served to all participants. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat (3506 kJ; 838 kcal total)




Primary Outcome Measures :
  1. Postprandial blood glucose responses [ Time Frame: 0-360 minutes post breakfast ]
    Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch


Secondary Outcome Measures :
  1. Acute subjective appetite responses [ Time Frame: 0-360 minutes post breakfast ]
    Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals



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:

  • Metabolic disease or current illness
  • Regular breakfast skipper
  • Food allergies/intolerances
  • Eating disorders
  • Smoking

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): NCT02658110


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: Emma J Stevenson, PhD Northumbria University
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT02658110    
Other Study ID Numbers: HLSDA020415
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 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
Obesity
Overnutrition
Nutrition Disorders
Nutrients
Growth Substances
Physiological Effects of Drugs