HypercholesterolemiaPhase 4ProFiNCT01251991
Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia
A Phase 4 study testing Psyllium husks, Isolated soy protein and Isolated whey protein in people with Hypercholesterolemia, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the Western world. Hypercholesterolemia is a well known risk factor for developing cardiovascular disease. Prevention and treatment are based in part on lowering LDL cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Psyllium husks, Isolated soy protein and Isolated whey protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Jan 2012
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18,5 - 35 kg/m2
- LDL cholesterol > 3,5 mmol/l
Who cannot join
- Triglycerides > 5,0 mmol/l
- Use of phytosterols, food supplements containing soy protein or water soluble fiber supplements
- Cardiovascular disease
- Diabetes mellitus
- Gastrointestinal disease
- Liver- og kidney disease
Show all 11Show fewer
- Electrolyte imbalance
- Orlistat treatment
- Alcohol abuse
- Hypersensitivity to the interventional substances
- Pregnancy and nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additive Cholesterol Lowering Effect by Concomitant Treatment With Psyllium Husks and Isolated Soy Protein in Addition to Heart-healthy Diet in Hypercholesterolemia
Despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the Western world. Hypercholesterolemia is a well known risk factor for developing cardiovascular disease. Prevention and treatment are based in part on lowering LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a mean 10%. Further lowering of LDL cholesterol by means of food supplements have been demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of action responsible for the cholesterol lowering in these two food supplements are different, so there is a reason to expect an additive cholesterol lowering effect during concomitant treatment with both substances. The investigators want to investigate whether concomitant treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than single treatment with each of the substances.
- Conditions
- Hypercholesterolemia
- Being tested
- Psyllium husks, Isolated soy protein, Isolated whey protein, Microcrystalline cellulose
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium husksDrug
Oral suspension, oral use, two daily dosages consisting of 5 grams each
Isolated soy proteinDietary supplement
Oral suspension, oral use, 30 grams once per day
Isolated whey proteinDietary supplement
Oral suspension, oral use, 30 grams once per day
Microcrystalline celluloseOther
Oral suspension, oral use, two daily dosages consisting of 5 grams each
| Study group | Role | What they receive |
|---|---|---|
| Combinatorial treatment | Experimental | Not described Receives: Drug: Psyllium husks; Dietary Supplement: Isolated soy protein |
| Single treatment: Psyllium husks | Active comparator | Not described Receives: Drug: Psyllium husks; Dietary Supplement: Isolated whey protein |
| Single treatment: Isolated soy protein | Active comparator | Not described Receives: Dietary Supplement: Isolated soy protein; Other: Microcrystalline cellulose |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Isolated whey protein; Other: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in LDL cholesterol at 6 weeks
3rd and 4th visits equal the ends of the 1st and 2nd intervention period at +6 weeks and +16 weeks from baseline respectively (4 week wash-out period in between the intervention periods). 2nd visit includes randomization and baseline measurement, while 1st visit @ -4 weeks compared to baseline includes screening and inclusion
Measured: 3rd and 4th visits at the investigational site
Secondary outcomes (8)
Change from baseline in total cholesterol at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Change from baseline in HDL cholesterol at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Change from baseline in triglycerides at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Change from baseline in fasting plasma glucose at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Change from baseline in body weight at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Change from baseline in apolipoprotein B at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Change from baseline in small, dense LDL cholesterol at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Change from baseline in high sensitive CRP at 6 weeks
Measured: 3rd and 4th visits at the investigational site
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Sorensen, Aalborg University Hospital
- Investigators
- Erik B. Schmidt, Professor, MD, Principal investigator, Lipidklinikken, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251991
- Sponsor's protocol ID
- 2010-022822-34
- Acronym
- ProFi
- Status last verified
- Jun 2011
- First submitted
- 1 Dec 2010
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Cholesterol Lowering Effect by Concomitant Treatment With Psyllium Husks and Isolated Soy Protein in Addition to Heart-healthy Diet in Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01251991
- Acronym / sponsor ID
- ProFi / 2010-022822-34
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Dec 2010 (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.
Despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the Western world. Hypercholesterolemia is a well known risk factor for developing cardiovascular disease. Prevention and treatment are based in part on lowering LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a mean 10%. Further lowering of LDL cholesterol by means of food supplements have been demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of action responsible for the cholesterol lowering in these two food supplements are different, so there is a reason to expect an additive cholesterol lowering effect during concomitant treatment with both substances. The investigators want to investigate whether concomitant treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than single treatment with each of the substances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combinatorial treatment | Experimental | Drug: Psyllium husks, Dietary Supplement: Isolated soy protein |
| Single treatment: Psyllium husks | Active comparator | Drug: Psyllium husks, Dietary Supplement: Isolated whey protein |
| Single treatment: Isolated soy protein | Active comparator | Dietary Supplement: Isolated soy protein, Other: Microcrystalline cellulose |
| Control | Placebo comparator | Dietary Supplement: Isolated whey protein, Other: Microcrystalline cellulose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 18,5 - 35 kg/m2
- LDL cholesterol > 3,5 mmol/l
Key exclusion criteria (11 listed)
- Triglycerides > 5,0 mmol/l
- Use of phytosterols, food supplements containing soy protein or water soluble fiber supplements
- Cardiovascular disease
- Diabetes mellitus
- Gastrointestinal disease
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 |
|---|---|---|
| Psyllium husksOral suspension, oral use, two daily dosages consisting of 5 grams each | Drug | Combinatorial treatment, Single treatment: Psyllium husks |
| Isolated soy proteinOral suspension, oral use, 30 grams once per day | Dietary supplement | Combinatorial treatment, Single treatment: Isolated soy protein |
| Isolated whey proteinOral suspension, oral use, 30 grams once per day | Dietary supplement | Control, Single treatment: Psyllium husks |
| Microcrystalline celluloseOral suspension, oral use, two daily dosages consisting of 5 grams each | Other | Control, Single treatment: Isolated soy protein |
Primary outcome
Change from baseline in LDL cholesterol at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
3rd and 4th visits equal the ends of the 1st and 2nd intervention period at +6 weeks and +16 weeks from baseline respectively (4 week wash-out period in between the intervention periods). 2nd visit includes randomization and baseline measurement, while 1st visit @ -4 weeks compared to baseline includes screening and inclusion
8 secondary outcomes
Change from baseline in total cholesterol at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
Change from baseline in HDL cholesterol at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
Change from baseline in triglycerides at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
Change from baseline in fasting plasma glucose at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
Change from baseline in body weight at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
Change from baseline in apolipoprotein B at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
Change from baseline in small, dense LDL cholesterol at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
Change from baseline in high sensitive CRP at 6 weeks
Time frame: 3rd and 4th visits at the investigational site
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 29 Jan 2014.
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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.
Erik B. Schmidt, Professor, MD principal investigator
Lipidklinikken, Aalborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psyllium husks, Isolated soy protein and Isolated whey protein in people with Hypercholesterolemia, run by Aalborg University Hospital at 1 site in Denmark.
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 2 inclusion and 11 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 29 Jan 2014. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from baseline in LDL cholesterol at 6 weeks (time frame: 3rd and 4th visits at the investigational site). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2014.