Skip to main content
Clinical Trials/NCT02658110
NCT02658110CompletedNot Applicable

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

Northumbria University1 site in 1 country14 target enrollmentStarted: July 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Postprandial blood glucose responses

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Criteria for inclusion are as follows:
  • •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

Exclusion Criteria

  • Not provided

Arms & Interventions

Non Protein Trial

Sham Comparator

Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein

Intervention: Mixed Macronutrient Breakfast Meal (Other)

Non Protein Trial

Sham Comparator

Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein

Intervention: Mixed Macronutrient Lunch Meal (Other)

Preload Trial

Experimental

Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal

Intervention: Mixed Macronutrient Breakfast Meal (Other)

Preload Trial

Experimental

Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal

Intervention: Mixed Macronutrient Lunch Meal (Other)

With Meal Trial

Experimental

Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal

Intervention: Mixed Macronutrient Breakfast Meal (Other)

With Meal Trial

Experimental

Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal

Intervention: Mixed Macronutrient Lunch Meal (Other)

Post Meal Trial

Experimental

Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal

Intervention: Mixed Macronutrient Breakfast Meal (Other)

Post Meal Trial

Experimental

Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal

Intervention: Mixed Macronutrient Lunch Meal (Other)

Post Meal Trial

Experimental

Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal

Intervention: Whey Protein (Dietary Supplement)

With Meal Trial

Experimental

Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal

Intervention: Whey Protein (Dietary Supplement)

Preload Trial

Experimental

Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal

Intervention: Whey Protein (Dietary Supplement)

Outcomes

Primary Outcomes

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 Outcomes

  • Acute subjective appetite responses(0-360 minutes post breakfast)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials