Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion

Acute Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion in Overweight and Obese Males

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Abdominal
• Intervention / Treatment: Other: Mixed Macronutrient Breakfast Meal; Other: Mixed Macronutrient Lunch Meal; Dietary supplement: Whey Protein

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne and Wear
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
      • Faculty of Health and Life Sciences, Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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	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); Dietary supplement: Whey Protein; 20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
Experimental: With Meal Trial; Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal	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); Dietary supplement: Whey Protein; 20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
Experimental: Post Meal Trial; Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal	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); Dietary supplement: Whey Protein; 20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial blood glucose responses	Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch	0-360 minutes post breakfast

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute subjective appetite responses	Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals	0-360 minutes post breakfast

Collaborators and Investigators

• Sponsor: Northumbria University
• Investigators: Study Director: Emma J Stevenson, PhD, Northumbria University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Postprandial glycemia; Metabolic health measures
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: HLSDA020415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO