Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion

NCT ID: NCT02658110

Last Updated: 2016-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Obesity, Abdominal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Non Protein Trial

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

Group Type SHAM_COMPARATOR

Mixed Macronutrient Breakfast Meal

Intervention Type OTHER

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

Intervention Type OTHER

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)

Preload Trial

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

Group Type EXPERIMENTAL

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage

Mixed Macronutrient Breakfast Meal

Intervention Type OTHER

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

Intervention Type OTHER

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)

With Meal Trial

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

Group Type EXPERIMENTAL

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage

Mixed Macronutrient Breakfast Meal

Intervention Type OTHER

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

Intervention Type OTHER

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)

Post Meal Trial

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

Group Type EXPERIMENTAL

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage

Mixed Macronutrient Breakfast Meal

Intervention Type OTHER

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

Intervention Type OTHER

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)

Interventions

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Whey Protein

20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emma J Stevenson, PhD

Role: STUDY_DIRECTOR

Northumbria University

Locations

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Faculty of Health and Life Sciences, Northumbria University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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HLSDA020415

Identifier Type: -

Identifier Source: org_study_id

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