Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion

Obesity, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658110
• Other study ID #: HLSDA020415
• Status: Completed
• Phase: N/A
• First received: January 14, 2016
• Last updated: January 14, 2016
• Start date: July 2015
• Est. completion date: October 2015

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• 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:

• Metabolic disease or current illness

• Regular breakfast skipper

• Food allergies/intolerances

• Eating disorders

• Smoking

Study Design

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

Related Conditions & MeSH terms

• Obesity, Abdominal

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 kJ; 468 kcal total)
• 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)

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 and post-lunch	0-360 minutes post breakfast	No
Secondary	Acute subjective appetite responses	Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals	0-360 minutes post breakfast	No