NCT02714309

Brief Summary

Consuming whey protein may have beneficial effects on health, principally by having an impact on blood glucose metabolism, but also by affecting appetite. The purpose of this project is to investigate the effect of consuming whey protein preload prior to breakfast, following a bout of low/moderate intensity exercise (brisk walking), on glucose and lipids in the blood as well as on appetite. It is hypothesised that the consumption of whey protein before a meal after prior low/moderate intensity exercise may positively affect postprandial handling as well as appetite sensations and consequently reduce intake at a subsequent meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

March 16, 2016

Last Update Submit

July 4, 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

    0-240 minutes post breakfast

Secondary Outcomes (1)

  • Energy intake at ad libitum lunch meal

    240 minutes post breakfast breakfast

Study Arms (3)

Control Trial

EXPERIMENTAL

A mixed macronutrient breakfast meal is consumed without additional protein, following a period of rest. An ad libitum lunch meal is subsequently consumed.

Other: Mixed macronutrient breakfast mealOther: Ad libitum lunch meal

Exercise No Preload Trial

EXPERIMENTAL

Following an exercise bout a mixed macronutrient breakfast meal is consumed without additional protein. An ad libitum lunch meal is subsequently consumed.

Other: Mixed macronutrient breakfast mealOther: Ad libitum lunch mealOther: Low/moderate intensity exercise

Exercise With Preload Trial

EXPERIMENTAL

Following low/moderate intensity exercise bout, whey protein (20g) administered prior to consumption of mixed macronutrient breakfast meal. An ad libitum lunch meal is subsequently consumed.

Dietary Supplement: Whey proteinOther: Mixed macronutrient breakfast mealOther: Ad libitum lunch mealOther: Low/moderate intensity exercise

Interventions

Whey proteinDIETARY_SUPPLEMENT

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

Exercise With Preload Trial

A standardised mixed-macronutrient breakfast served to all participants. The macronutrient distribution of the breakfast is 13% protein, 70% carbohydrate, 17% fat (1958 kilojoules (kJ); 468 kcal total)

Control TrialExercise No Preload TrialExercise With Preload Trial

A mixed-macronutrient lunch served to all participants ad libitum. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat

Control TrialExercise No Preload TrialExercise With Preload Trial

A 30 minute bout of treadmill walking is performed on a motorised treadmill at a low/moderate intensity (55% estimated VO2max)

Exercise No Preload TrialExercise With Preload 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: * Cardiovascular, metabolic or renal disease * Current illness * Regular breakfast skipper * Food allergies or intolerances * Eating disorders * Smoker * Inadequate venous access * Taking medication that may affect metabolism

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

Related Publications (1)

  • Allerton DM, West DJ, Stevenson EJ. Whey protein consumption following fasted exercise reduces early postprandial glycaemia in centrally obese males: a randomised controlled trial. Eur J Nutr. 2021 Mar;60(2):999-1011. doi: 10.1007/s00394-020-02304-2. Epub 2020 Jun 22.

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

  • Penny L Rumbold, 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

March 16, 2016

First Posted

March 21, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 6, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations