HypertensionNCT02090842
Milk Proteins, Ambulatory Blood Pressure and Vascular Function
A study testing Ca-caseinate, Maltodextrin and Whey protein isolate in people with Hypertension, run by University of Reading at 1 site in United Kingdom.
Trial summary
Epidemiological studies demonstrated an inverse associations between cardiovascular events and milk and dairy product consumption. Evidence from human intervention studies suggests that both whey and casein may be effective in blood pressure-lowering, however there is limited data on the impact of milk proteins on… Read more about this study
- Who is it for?
- Ages 30 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Ca-caseinate, Maltodextrin and Whey protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Feb 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 30 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A signed consent form
- Blood pressure: 120/80-159/99
- Age: 30-77 years
- BMI 20-40 kg/m2
- Glucose <7 mmol/l (Not diagnosed with diabetes)
- Chol <8 mmol/l
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- TAG <4 mmol/l
- Normal liver and kidney function
- Haemoglobin (>110 g/dl women; 140g/dl men)
Who cannot join
- Milk allergy, lactose allergy
- Coeliac disease
- Renal, gastrointestinal, respiratory, endocrine, liver disease or cancer
- Surgery in the previous 6 months
- Secondary hypertension
- Excess alcohol consumption (drinking >28 unit/wk man; >21 unit/wk women)
Show all 10Show fewer
- Smoker
- Vegan
- Taking nutritional supplementation (e.g. fish oil, proteins)
- Anaemia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berks, RG6 6AP
About this study
Official title: Investigating the Acute and Chronic Effects of Dietary Proteins on Markers of Vascular Function, Ambulatory Blood Pressure, Insulin Resistance and Lipid Metabolism.
Epidemiological studies demonstrated an inverse associations between cardiovascular events and milk and dairy product consumption. Evidence from human intervention studies suggests that both whey and casein may be effective in blood pressure-lowering, however there is limited data on the impact of milk proteins on vascular function. This research aims to compare the potential acute and chronic impacts of the two main milk proteins (whey and casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory status will also be investigated in 'at-risk' individuals.
This research includes both an acute and chronic intervention study which have been independently powered on the appropriate outcome measures. This has generated different sample size requirements for the two studies (Actual participants on the acute study: n=27, and on the chronic study: n=38).
- Conditions
- Hypertension
- Being tested
- Ca-caseinate, Maltodextrin, Whey protein isolate
- Keywords
- Milk proteins, Blood pressure, Vascular function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca-caseinateDietary supplement
MaltodextrinDietary supplement
Whey protein isolateDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Whey protein isolate | Experimental | Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks. Receives: Dietary Supplement: Whey protein isolate |
| Ca-caseinate | Experimental | Subjects are asked to supplement their habitual diet with 56 g of Ca-caseinate a day for 8 weeks. Receives: Dietary Supplement: Ca-caseinate |
| Maltodextrin | Other | Subjects are asked to supplement their habitual diet with 54 g of maltodextrin a day for 8 weeks. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-h ambulatory blood pressure
Measured: Chronic study: Baseline and week 8 assessments for the three dietary intervention arms, Acute study: automated ambulatory blood monitor measures every 15 minutes for 3 hours after both meals, then every 30 minutes for day
Secondary outcomes (6)
Changes in vascular reactivity measured by flow-mediated dilation (FMD)
Measured: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
Changes in plasma lipids
Measured: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in markers of insulin resistance
Measured: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in inflammatory markers
Measured: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in arterial stiffness measured by pulse wave analysis (PWA)
Measured: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
Changes in arterial stiffness measured by digital volume pulse (DVP)
Measured: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Volac Int. Ltd.
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A. Lovegrove, BSc, PhD, RNutr, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090842
- Sponsor's protocol ID
- 12/40
- Status last verified
- Jan 2016
- First submitted
- 17 Jun 2013
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pal S, Ellis V. Acute effects of whey protein isolate on blood pressure, vascular function and inflammatory markers in overweight postmenopausal women. Br J Nutr. 2011 May;105(10):1512-9. doi: 10.1017/S0007114510005313. Epub 2011 Jan 28.
PubMed 21272399Pal S, Ellis V. The chronic effects of whey proteins on blood pressure, vascular function, and inflammatory markers in overweight individuals. Obesity (Silver Spring). 2010 Jul;18(7):1354-9. doi: 10.1038/oby.2009.397. Epub 2009 Nov 5.
PubMed 19893505Fekete AA, Giromini C, Chatzidiakou Y, Givens DI, Lovegrove JA. Whey protein lowers blood pressure and improves endothelial function and lipid biomarkers in adults with prehypertension and mild hypertension: results from the chronic Whey2Go randomized controlled trial. Am J Clin Nutr. 2016 Dec;104(6):1534-1544. doi: 10.3945/ajcn.116.137919. Epub 2016 Oct 26.
PubMed 27797709
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Acute and Chronic Effects of Dietary Proteins on Markers of Vascular Function, Ambulatory Blood Pressure, Insulin Resistance and Lipid Metabolism.
- ClinicalTrials.gov ID
- NCT02090842
- Acronym / sponsor ID
- 12/40
- Conditions
- Hypertension
- Keywords
- Milk proteins, Blood pressure, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Volac Int. Ltd.
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Mar 2014 (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.
Epidemiological studies demonstrated an inverse associations between cardiovascular events and milk and dairy product consumption. Evidence from human intervention studies suggests that both whey and casein may be effective in blood pressure-lowering, however there is limited data on the impact of milk proteins on vascular function. This research aims to compare the potential acute and chronic impacts of the two main milk proteins (whey and casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory status will also be investigated in 'at-risk' individuals.
This research includes both an acute and chronic intervention study which have been independently powered on the appropriate outcome measures. This has generated different sample size requirements for the two studies (Actual participants on the acute study: n=27, and on the chronic study: n=38).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey protein isolate | Experimental | Dietary Supplement: Whey protein isolateSubjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks. |
| Ca-caseinate | Experimental | Dietary Supplement: Ca-caseinateSubjects are asked to supplement their habitual diet with 56 g of Ca-caseinate a day for 8 weeks. |
| Maltodextrin | Other | Dietary Supplement: MaltodextrinSubjects are asked to supplement their habitual diet with 54 g of maltodextrin a day for 8 weeks. |
Who may qualify
- Ages
- 30 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A signed consent form
- Blood pressure: 120/80-159/99
- Age: 30-77 years
- BMI 20-40 kg/m2
- Glucose <7 mmol/l (Not diagnosed with diabetes)
Key exclusion criteria (10 listed)
- Milk allergy, lactose allergy
- Coeliac disease
- Renal, gastrointestinal, respiratory, endocrine, liver disease or cancer
- Surgery in the previous 6 months
- Secondary hypertension
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 |
|---|---|---|
| Ca-caseinate | Dietary supplement | Ca-caseinate |
| Maltodextrin | Dietary supplement | Maltodextrin |
| Whey protein isolate | Dietary supplement | Whey protein isolate |
Primary outcome
Change in 24-h ambulatory blood pressure
Time frame: Chronic study: Baseline and week 8 assessments for the three dietary intervention arms, Acute study: automated ambulatory blood monitor measures every 15 minutes for 3 hours after both meals, then every 30 minutes for day
6 secondary outcomes
Changes in vascular reactivity measured by flow-mediated dilation (FMD)
Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
Changes in plasma lipids
Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in markers of insulin resistance
Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in inflammatory markers
Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in arterial stiffness measured by pulse wave analysis (PWA)
Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
Changes in arterial stiffness measured by digital volume pulse (DVP)
Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
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 11 Jan 2016.
- Background: PubMed 21272399Pal S, Ellis V. Acute effects of whey protein isolate on blood pressure, vascular function and inflammatory markers in overweight postmenopausal women. Br J Nutr. 2011 May;105(10):1512-9. doi: 10.1017/S0007114510005313. Epub 2011 Jan 28.
- Background: PubMed 19893505Pal S, Ellis V. The chronic effects of whey proteins on blood pressure, vascular function, and inflammatory markers in overweight individuals. Obesity (Silver Spring). 2010 Jul;18(7):1354-9. doi: 10.1038/oby.2009.397. Epub 2009 Nov 5.
- Derived from this study: PubMed 27797709Fekete AA, Giromini C, Chatzidiakou Y, Givens DI, Lovegrove JA. Whey protein lowers blood pressure and improves endothelial function and lipid biomarkers in adults with prehypertension and mild hypertension: results from the chronic Whey2Go randomized controlled trial. Am J Clin Nutr. 2016 Dec;104(6):1534-1544. doi: 10.3945/ajcn.116.137919. Epub 2016 Oct 26.
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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.
Julie A. Lovegrove, BSc, PhD, RNutr principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ca-caseinate, Maltodextrin and Whey protein isolate in people with Hypertension, run by University of Reading 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 11 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. 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?
Change in 24-h ambulatory blood pressure (time frame: Chronic study: Baseline and week 8 assessments for the three dietary intervention arms, Acute study: automated ambulatory blood monitor measures every 15 minutes for 3 hours after both meals, then every 30 minutes for day). 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 NCT02090842, which also lists 3 linked publications.
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 11 Jan 2016.