Obesity, AbdominalNCT02658110

Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion

A study testing Whey Protein, Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal in people with Obesity, Abdominal, run by Northumbria University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: Obesity, Abdominal
What is being tested?: Whey Protein, Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2015to Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
No healthy volunteers
Adult

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Faculty of Health and Life Sciences, Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions: Obesity, Abdominal
Being tested: Whey Protein, Mixed Macronutrient Breakfast Meal, Mixed Macronutrient Lunch Meal
Keywords: Postprandial glycemia, Metabolic health measures
Medical subject headings: Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whey ProteinDietary supplement
20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
Mixed Macronutrient Breakfast MealOther
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 MealOther
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)

Study groups in NCT02658110
Study group	Role	What they receive
Non Protein Trial	Sham comparator	Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein Receives: Other: Mixed Macronutrient Breakfast Meal; Other: Mixed Macronutrient Lunch Meal
Preload Trial	Experimental	Whey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal Receives: Dietary Supplement: Whey Protein; Other: Mixed Macronutrient Breakfast Meal; Other: Mixed Macronutrient Lunch Meal
With Meal Trial	Experimental	Whey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal Receives: Dietary Supplement: Whey Protein; Other: Mixed Macronutrient Breakfast Meal; Other: Mixed Macronutrient Lunch Meal
Post Meal Trial	Experimental	Whey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal Receives: Dietary Supplement: Whey Protein; Other: Mixed Macronutrient Breakfast Meal; Other: Mixed Macronutrient Lunch Meal

What is being measured

The primary outcome is the main question the study is designed to answer.

Postprandial blood glucose responses
Blood glucose concentration determined in whole blood sampled at regular intervals post-breakfast and post-lunch
Measured: 0-360 minutes post breakfast

Secondary outcomes (1)

Acute subjective appetite responses
Subjective appetite ratings determined from Visual Analogue Scales sampled at regular intervals
Measured: 0-360 minutes post breakfast

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Oct 2015

First posted18 Jan 2016 (estimated)
Study startJul 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02658110
Sponsor's protocol ID: HLSDA020415
Status last verified: Jan 2016
First submitted: 14 Jan 2016
Last updated: 18 Jan 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity, Abdominal trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Metabolic and Appetite Responses to Altered Timing of Whey Protein Ingestion in Overweight and Obese Males
ClinicalTrials.gov ID: NCT02658110
Acronym / sponsor ID: HLSDA020415
Conditions: Obesity, Abdominal
Keywords: Postprandial glycemia, Metabolic health measures
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Northumbria UniversityUniversity, hospital or other
Study start: Jul 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 18 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Non Protein Trial	Sham comparator	Other: Mixed Macronutrient Breakfast Meal, Other: Mixed Macronutrient Lunch MealMixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal served without additional whey protein
Preload Trial	Experimental	Dietary Supplement: Whey Protein, Other: Mixed Macronutrient Breakfast Meal, Other: Mixed Macronutrient Lunch MealWhey protein (20g) administered 15 minutes prior to Mixed Macronutrient Breakfast Meal
With Meal Trial	Experimental	Dietary Supplement: Whey Protein, Other: Mixed Macronutrient Breakfast Meal, Other: Mixed Macronutrient Lunch MealWhey protein (20g) administered alongside Mixed Macronutrient Breakfast Meal
Post Meal Trial	Experimental	Dietary Supplement: Whey Protein, Other: Mixed Macronutrient Breakfast Meal, Other: Mixed Macronutrient Lunch MealWhey protein (20g) administered 15 minutes after Mixed Macronutrient Breakfast Meal

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whey Protein20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage	Dietary supplement	Post Meal Trial, Preload Trial, With Meal Trial
Mixed Macronutrient Breakfast MealA 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)	Other	Non Protein Trial, Post Meal Trial, Preload Trial, With Meal Trial
Mixed Macronutrient Lunch MealA 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)	Other	Non Protein Trial, Post Meal Trial, Preload Trial, With Meal Trial

Primary outcome

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

1 secondary outcome

Acute subjective appetite responses
Time frame: 0-360 minutes post breakfast

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
Individual participant dataSharing planned: No

Related trials for Obesity, Abdominal

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emma J Stevenson, PhD study director

Northumbria University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Whey Protein, Mixed Macronutrient Breakfast Meal and Mixed Macronutrient Lunch Meal in people with Obesity, Abdominal, run by Northumbria University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial blood glucose responses (time frame: 0-360 minutes post breakfast). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.