HypercholesterolemiaPhase 2NCT00334308
Barley Protein and CVD
A Phase 2 study of Hypercholesterolemia and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.
Trial summary
The Question posed is: Does an barley protein concentrate have health benefits similar to those demonstrated for soy protein foods which would justify the use of the non-fiber components of barley as functional food ingredients? Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Disease, Diet Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and postmenopausal women with mild- to-moderate hypercholesterolemia
- Body mass index >18 kg/m2 and < 36 kg/m2.
- treated by diet
- Alcohol intake < 14 drinks per week.
- Fasting plasma triglyceride (TG) concentration > 0.5 mmol/l and < 4.5 mmol/l.
- Fasting plasma LDL cholesterol concentration > 3.5 mmol/l at diagnosis.
Who cannot join
- Child-bearing women
- Taking cholesterol lowering medications at the start of the study, unless their LDL-cholesterol levels are >3.5 mmol/L.However, with their physician's approval those who wish to join but are already taking cholesterol lowering medications with low LDL-cholesterol levels (e.g. <2.5 mmol/L) may join the study providing the medications are stopped for one month.
- Change the type or dose of their drug treatment during the study
- Patients judged as having a likelihood of being non-compliant with instructions for whatever reason
- Food allergies
- Evidence or history of diabetes, renal liver disease or gastrointestinal disease
Show all 10Show fewer
- Recent (within 6 months)) major cardiovascular event (stroke or myocardial infarction)
- Secondary causes of hypercholesterolemia (or untreated hypothyroidism)
- Uncontrolled blood pressure
- Major disability or disorder such as liver disease, renal failure or cancer or with major surgery < 6 months prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Barley Protein and Coronary Heart Disease Risk Reduction
The Question posed is: Does an barley protein concentrate have health benefits similar to those demonstrated for soy protein foods which would justify the use of the non-fiber components of barley as functional food ingredients? Hypotheses: 1. Cholesterol Lowering: There is good evidence indicating that soy protein lowers serum cholesterol levels. The evidence was strong enough for a health claim for coronary heart disease risk reduction to be approved by the FDA. In addition, we have found that wheat gluten significantly reduced serum triglyceride levels. However, there is a need to assess the possible health benefits other vegetable protein sources. Barley is grown in relatively large amounts in Canada and barley protein would be a readily available vegetable protein source if health attributes could be ascribed to it. In addition other components of barley, including plant sterols and phenolics, may have hypocholesterolemic and antioxidant properties. 2. Antioxidant: In addition to cholesterol-lowering and possibly of equal importance in terms of prevention of cardiovascular and other chronic diseases, the barley phenolics associated with barley protein and may have added benefits as antioxidants. 3. Markers of Inflammation: Barley components are considered to be hypoallergenic. Hence their use in the cosmetic industry. Auto-immune and inflammatory responses are associated with increased CHD risk. Barley protein consumption may therefore reduce the levels of the pro-inflammatory cytokines; and the acute phase proteins. 4. Arterial Dilatation: Barley proteins may also have beneficial effects on vascular reactivity which may reduce CHD risk on account of their higher arginine:lysine ratio. Arginine enhances nitric oxide synthesis associated with endothelial relaxation and arterial dilatation. Barley may therefore increase pulmonary nitric oxide levels.
Read the detailed description
Design: The effect of oat protein extract will be assessed in one-month feeding studies of forty healthy men and women with raised serum cholesterol levels. Two breads will be prepared, one control and one providing 45 g/d barley protein to be fed for one month each in a randomized crossover design.
Diets: The diets will be the subjects' usual diets which appropriately will be NCEP Step 2 diets for patients treated without medications with this degree of hyperlipidemia. Those who are not on an NCEP Step 2 diet will be instructed accordingly. During the first phase, the two one-week recorded diets for each patient will be photocopied and returned to the patient to be used as the dietary model for the subsequent period. We have found that this approach is effective in stabilizing the diets in our soy protein studies. Supplements: Will be breads with test and control supplements providing the identical daily energy intake. The increase in protein in the barley supplements will be matched by the use of protein from milk protein (casein). Similarly the increased polyunsaturated, monounsaturated and saturated fatty acids in the test supplement will be matched by addition of an appropriate blend of oils in the control. Baked goods will be prepared at our clinic and a seven-day supply will be provided to each participant at the beginning of each week. The exact formulation of the supplements will involve product development, palatability testing and chemical analysis of the prototypes in the initial phase of the study. Compliance: compliance will be assessed from completed weekly diet records where supplement intake is recorded daily. These records will be reviewed by a dietitian with the subject at the end of the week. In addition, uneaten supplements will be returned, weighed and noted on the menu plans by the dietitian. Diet records will also be assessed to ensure the predetermined diet plan is followed according to the phase one recorded diet.
- Conditions
- Hypercholesterolemia, Cardiovascular Disease, Diet Therapy
- Being tested
- Barley protein bread or control (casein) bread
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barley protein bread or control (casein) breadProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
total and LDL cholesterol, LDL:HDL cholesterol ratio
Secondary outcomes (1)
Blood pressure, HDL cholesterol, HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size; oxidative stress,inflammatory biomarkers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2006 (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 HypercholesterolemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- David JA Jenkins, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334308
- Sponsor's protocol ID
- REB 02-113C
- Status last verified
- Jan 2009
- First submitted
- 6 Jun 2006
- Last updated
- 21 Jan 2009
- Results posted
- No
Publications
Jenkins DJ, Srichaikul K, Wong JM, Kendall CW, Bashyam B, Vidgen E, Lamarche B, Rao AV, Jones PJ, Josse RG, Jackson CJ, Ng V, Leong T, Leiter LA. Supplemental barley protein and casein similarly affect serum lipids in hypercholesterolemic women and men. J Nutr. 2010 Sep;140(9):1633-7. doi: 10.3945/jn.110.123224. Epub 2010 Jul 28.
PubMed 20668250
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barley Protein and Coronary Heart Disease Risk Reduction
- ClinicalTrials.gov ID
- NCT00334308
- Acronym / sponsor ID
- REB 02-113C
- Conditions
- Hypercholesterolemia, Cardiovascular Disease, Diet Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- First posted
- 7 Jun 2006 (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 Question posed is: Does an barley protein concentrate have health benefits similar to those demonstrated for soy protein foods which would justify the use of the non-fiber components of barley as functional food ingredients? Hypotheses: 1. Cholesterol Lowering: There is good evidence indicating that soy protein lowers serum cholesterol levels. The evidence was strong enough for a health claim for coronary heart disease risk reduction to be approved by the FDA. In addition, we have found that wheat gluten significantly reduced serum triglyceride levels. However, there is a need to assess the possible health benefits other vegetable protein sources. Barley is grown in relatively large amounts in Canada and barley protein would be a readily available vegetable protein source if health attributes could be ascribed to it. In addition other components of barley, including plant sterols and phenolics, may have hypocholesterolemic and antioxidant properties. 2. Antioxidant: In addition to cholesterol-lowering and possibly of equal importance in terms of prevention of cardiovascular and other chronic diseases, the barley phenolics associated with barley protein and may have added benefits as antioxidants. 3. Markers of Inflammation: Barley components are considered to be hypoallergenic. Hence their use in the cosmetic industry. Auto-immune and inflammatory responses are associated with increased CHD risk. Barley protein consumption may therefore reduce the levels of the pro-inflammatory cytokines; and the acute phase proteins. 4. Arterial Dilatation: Barley proteins may also have beneficial effects on vascular reactivity which may reduce CHD risk on account of their higher arginine:lysine ratio. Arginine enhances nitric oxide synthesis associated with endothelial relaxation and arterial dilatation. Barley may therefore increase pulmonary nitric oxide levels.
Detailed description
Design: The effect of oat protein extract will be assessed in one-month feeding studies of forty healthy men and women with raised serum cholesterol levels. Two breads will be prepared, one control and one providing 45 g/d barley protein to be fed for one month each in a randomized crossover design.
Diets: The diets will be the subjects' usual diets which appropriately will be NCEP Step 2 diets for patients treated without medications with this degree of hyperlipidemia. Those who are not on an NCEP Step 2 diet will be instructed accordingly. During the first phase, the two one-week recorded diets for each patient will be photocopied and returned to the patient to be used as the dietary model for the subsequent period. We have found that this approach is effective in stabilizing the diets in our soy protein studies. Supplements: Will be breads with test and control supplements providing the identical daily energy intake. The increase in protein in the barley supplements will be matched by the use of protein from milk protein (casein). Similarly the increased polyunsaturated, monounsaturated and saturated fatty acids in the test supplement will be matched by addition of an appropriate blend of oils in the control. Baked goods will be prepared at our clinic and a seven-day supply will be provided to each participant at the beginning of each week. The exact formulation of the supplements will involve product development, palatability testing and chemical analysis of the prototypes in the initial phase of the study. Compliance: compliance will be assessed from completed weekly diet records where supplement intake is recorded daily. These records will be reviewed by a dietitian with the subject at the end of the week. In addition, uneaten supplements will be returned, weighed and noted on the menu plans by the dietitian. Diet records will also be assessed to ensure the predetermined diet plan is followed according to the phase one recorded diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- men and postmenopausal women with mild- to-moderate hypercholesterolemia
- Body mass index >18 kg/m2 and < 36 kg/m2.
- treated by diet
- Alcohol intake < 14 drinks per week.
- Fasting plasma triglyceride (TG) concentration > 0.5 mmol/l and < 4.5 mmol/l.
Key exclusion criteria (10 listed)
- Child-bearing women
- Taking cholesterol lowering medications at the start of the study, unless their LDL-cholesterol levels are >3.5 mmol/L.However, with their physician's approval those who wish to join but are already taking cholesterol lowering medications with low LDL-cholesterol levels (e.g. <2.5 mmol/L) may join the study providing the medications are stopped for one month.
- Change the type or dose of their drug treatment during the study
- Patients judged as having a likelihood of being non-compliant with instructions for whatever reason
- Food allergies
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 |
|---|---|---|
| Barley protein bread or control (casein) bread | Procedure or surgery | – |
Primary outcome
total and LDL cholesterol, LDL:HDL cholesterol ratio
1 secondary outcome
Blood pressure, HDL cholesterol, HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size; oxidative stress,inflammatory biomarkers
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 21 Jan 2009.
- Derived from this study: PubMed 20668250Jenkins DJ, Srichaikul K, Wong JM, Kendall CW, Bashyam B, Vidgen E, Lamarche B, Rao AV, Jones PJ, Josse RG, Jackson CJ, Ng V, Leong T, Leiter LA. Supplemental barley protein and casein similarly affect serum lipids in hypercholesterolemic women and men. J Nutr. 2010 Sep;140(9):1633-7. doi: 10.3945/jn.110.123224. Epub 2010 Jul 28.
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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.
David JA Jenkins, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Hypercholesterolemia and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.
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 6 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 21 Jan 2009. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
total and LDL cholesterol, LDL:HDL cholesterol ratio. 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 NCT00334308, 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 21 Jan 2009.