Type II Diabetes MellitusNCT02903199
Whey Protein Effect on Glycaemic and Appetite Responses in T2D
A study testing Whey Protein and Hydrolysed Protein in people with Type II Diabetes Mellitus and Glucose Metabolism Disorders, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The current study will investigate the effect if whey protein on postprandial glycaemia and appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control (leptin, PYY3-36) hormone responses. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Type II Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
- What is being tested?
- Whey Protein and Hydrolysed Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Oct 2016
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II diabetic males aged 18-65 years old.
- Treated with metformin, or diet and lifestyle modification, only.
- BMI < 40 kg/m2.
- Stable physical activity pattern during the three months immediately preceding study.
Who cannot join
- Not treated with insulin.
- No metabolic disease other than diabetes.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
About this study
Official title: The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males
The current study will investigate the effect if whey protein on postprandial glycaemia and appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control (leptin, PYY3-36) hormone responses.
Read the detailed description
Whey protein accounts of ~20% of whole milk protein. Ingestion of whey protein at meal times generates insulinotrophic/β-cell stimulation via amino acid absorption and the bioactive peptides generated during gastrointestinal digestion, resulting in attenuation of postprandial blood glucose. The bioactive peptides stimulate the release of incretin hormone, GLP-1, and inhibit DPP-IV activity potentially decreasing the rate of GLP-1 degradation.
The current study will employ a randomised, double-blind, counter-balanced, cross-over design, whereby participants will each complete three trials; a) whey protein, b) hydrolysed protein, and c) placebo intervention. Hydrolysed protein provides amino acid content, without bioactive peptides associated with incretin release, therefore, demonstrating insulinotrophic properties, only.
Many studies within the literature are limited for practical reasons, such as investigating high dosages (30-50 g) of whey protein, or high glycaemic index meal types which would be unlikely to form part of habitual dietary activity of type II diabetics. Therefore, the current study will objectively measure postprandial glycaemic and appetite responses following the ingestion of whey/hydrolysed protein, whilst ensuring ecological validity, dosages (18 g) and test meals applicable to everyday life, and true clinical utility for managing type-II diabetes by integrating interventions into the habitual lives of type-II diabetic individuals.
- Being tested
- Whey Protein, Hydrolysed Protein, Placebo
- Keywords
- Whey Protein, Postprandial Glycaemia, Appetite Response
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinDietary supplement
Whey protein (18 g) administered immediately prior to breakfast and lunch meals.
Hydrolysed ProteinDietary supplement
Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.
PlaceboDietary supplement
Placebo intervention administered immediately prior to breakfast and lunch meals.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein | Experimental | Whey protein (18g) experimental supplement Receives: Dietary Supplement: Whey Protein |
| Hydrolysed Protein | Experimental | Hydrolysed whey protein (19.1g) experimental supplement Receives: Dietary Supplement: Hydrolysed Protein |
| Placebo | Placebo comparator | Water placebo supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial capillary glucose
Capillary glucose concentrations are monitored for 6 hours/wk following breakfast (09:00-12:00) and lunch (12:15-15:15).
Measured: 6 hours per week, for 3 weeks.
Secondary outcomes (9)
Plasma Glucagon-like Peptide-1 (GLP-1)
GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Measured: 3 weeks
Plasma Gastric Inhibitory Polypeptide (GIP)
GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Measured: 3 weeks
Plasma Leptin
Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Measured: 3 weeks
Plasma Peptide YY (PYY3-36)
PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Measured: 3 weeks
Plasma Insulin
Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Measured: 3 weeks
Serum Triglycerides
Triglycerides will be measured from Serum Separating Tubes (SST).
Measured: 3 weeks
Serum Glycerol
Glycerol will be measured from Serum Separating Tubes (SST).
Measured: 3 weeks
Self-Report Questionnaire for Appetite
Visual Analogue Scales (VAS) will be used to assess self reported feelings of appetite sensations (i.e. hunger, satiety, prospective food intake).
Measured: 3 weeks
24 h Interstitial Glucose
Interstitial glucose is measured from 36 h prior to the trial, until 24 h following the trial, each week for three weeks.
Measured: 3 days per week, for 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Walker, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903199
- Sponsor's protocol ID
- NorthumbriaT2D
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
King DG, Walker M, Campbell MD, Breen L, Stevenson EJ, West DJ. A small dose of whey protein co-ingested with mixed-macronutrient breakfast and lunch meals improves postprandial glycemia and suppresses appetite in men with type 2 diabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Apr 1;107(4):550-557. doi: 10.1093/ajcn/nqy019.
PubMed 29635505
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males
- ClinicalTrials.gov ID
- NCT02903199
- Acronym / sponsor ID
- NorthumbriaT2D
- Keywords
- Whey Protein, Postprandial Glycaemia, Appetite Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 16 Sep 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.
The current study will investigate the effect if whey protein on postprandial glycaemia and appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control (leptin, PYY3-36) hormone responses.
Detailed description
Whey protein accounts of ~20% of whole milk protein. Ingestion of whey protein at meal times generates insulinotrophic/β-cell stimulation via amino acid absorption and the bioactive peptides generated during gastrointestinal digestion, resulting in attenuation of postprandial blood glucose. The bioactive peptides stimulate the release of incretin hormone, GLP-1, and inhibit DPP-IV activity potentially decreasing the rate of GLP-1 degradation.
The current study will employ a randomised, double-blind, counter-balanced, cross-over design, whereby participants will each complete three trials; a) whey protein, b) hydrolysed protein, and c) placebo intervention. Hydrolysed protein provides amino acid content, without bioactive peptides associated with incretin release, therefore, demonstrating insulinotrophic properties, only.
Many studies within the literature are limited for practical reasons, such as investigating high dosages (30-50 g) of whey protein, or high glycaemic index meal types which would be unlikely to form part of habitual dietary activity of type II diabetics. Therefore, the current study will objectively measure postprandial glycaemic and appetite responses following the ingestion of whey/hydrolysed protein, whilst ensuring ecological validity, dosages (18 g) and test meals applicable to everyday life, and true clinical utility for managing type-II diabetes by integrating interventions into the habitual lives of type-II diabetic individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey Protein | Experimental | Dietary Supplement: Whey ProteinWhey protein (18g) experimental supplement |
| Hydrolysed Protein | Experimental | Dietary Supplement: Hydrolysed ProteinHydrolysed whey protein (19.1g) experimental supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboWater placebo supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type II diabetic males aged 18-65 years old.
- Treated with metformin, or diet and lifestyle modification, only.
- BMI < 40 kg/m2.
- Stable physical activity pattern during the three months immediately preceding study.
Key exclusion criteria (2 listed)
- Not treated with insulin.
- No metabolic disease other than diabetes.
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 ProteinWhey protein (18 g) administered immediately prior to breakfast and lunch meals. | Dietary supplement | Whey Protein |
| Hydrolysed ProteinHydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals. | Dietary supplement | Hydrolysed Protein |
| PlaceboPlacebo intervention administered immediately prior to breakfast and lunch meals. | Dietary supplement | Placebo |
Primary outcome
Postprandial capillary glucose
Time frame: 6 hours per week, for 3 weeks.
Capillary glucose concentrations are monitored for 6 hours/wk following breakfast (09:00-12:00) and lunch (12:15-15:15).
9 secondary outcomes
Plasma Glucagon-like Peptide-1 (GLP-1)
Time frame: 3 weeks
Plasma Gastric Inhibitory Polypeptide (GIP)
Time frame: 3 weeks
Plasma Leptin
Time frame: 3 weeks
Plasma Peptide YY (PYY3-36)
Time frame: 3 weeks
Plasma Insulin
Time frame: 3 weeks
Serum Triglycerides
Time frame: 3 weeks
Serum Glycerol
Time frame: 3 weeks
Self-Report Questionnaire for Appetite
Time frame: 3 weeks
24 h Interstitial Glucose
Time frame: 3 days per week, for 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Derived from this study: PubMed 29635505King DG, Walker M, Campbell MD, Breen L, Stevenson EJ, West DJ. A small dose of whey protein co-ingested with mixed-macronutrient breakfast and lunch meals improves postprandial glycemia and suppresses appetite in men with type 2 diabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Apr 1;107(4):550-557. doi: 10.1093/ajcn/nqy019.
- Individual participant dataSharing planned: Undecided
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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.
Mark Walker principal investigator
Newcastle 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 and Hydrolysed Protein in people with Type II Diabetes Mellitus and Glucose Metabolism Disorders, 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 16 Sep 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?
Results are not available in the source record.
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 capillary glucose (time frame: 6 hours per week, for 3 weeks.). 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 NCT02903199, which also lists 1 linked publication.
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 16 Sep 2016.