NCT02658110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

January 14, 2016

Last Update Submit

January 14, 2016

Conditions

Keywords

Postprandial glycemiaMetabolic health measures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acute subjective appetite responses

    0-360 minutes post breakfast

Study Arms (4)

Non Protein Trial

SHAM COMPARATOR

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

Other: Mixed Macronutrient Breakfast MealOther: Mixed Macronutrient Lunch Meal

Preload Trial

EXPERIMENTAL

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

Dietary Supplement: Whey ProteinOther: Mixed Macronutrient Breakfast MealOther: Mixed Macronutrient Lunch Meal

With Meal Trial

EXPERIMENTAL

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

Dietary Supplement: Whey ProteinOther: Mixed Macronutrient Breakfast MealOther: Mixed Macronutrient Lunch Meal

Post Meal Trial

EXPERIMENTAL

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

Dietary Supplement: Whey ProteinOther: Mixed Macronutrient Breakfast MealOther: Mixed Macronutrient Lunch Meal

Interventions

Whey ProteinDIETARY_SUPPLEMENT

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

Post Meal TrialPreload TrialWith Meal Trial

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)

Non Protein TrialPost Meal TrialPreload TrialWith Meal Trial

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)

Non Protein TrialPost Meal TrialPreload TrialWith Meal Trial

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health and Life Sciences, Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Emma J Stevenson, PhD

    Northumbria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations