HypercholesterolemiaNCT01408719
Effect of Beta-Glucan on Cholesterol Lowering
A study testing 3g LMW beta-glucan, 5g LMW beta-glucan and 3g HMW beta-glucan in people with Hypercholesterolemia, run by University of Manitoba at 1 site in Canada.
Trial summary
The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- 3g LMW beta-glucan, 5g LMW beta-glucan and 3g HMW beta-glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 20-40 kg/m2
- Fasting cholesterol levels of 5.0-8.0 mmol/L
- Fasting serum LDL cholesterol levels of 2.7-5.0 mmol/L
Who cannot join
- Pregnant or lactating
- Taking lipid lowering medication or nutritional supplements that affect blood lipids
- Dietary restrictions which would affect consuming the study diet for 5-wk for four study phases.
- Not deemed healthy by study physician
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Neutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed. Our second aim is to investigate the mechanism responsible for the action, specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet interactions are associated with cholesterol lowering by barley β-glucan. In addition, we aim to investigate the alteration of the gut microbiota after β-glucan consumption and the correlation between the altered gut microbiota and cardiovascular disease risk factors.
Read the detailed description
This study consists of four dietary phases which are separated by >28 days wash-out period. During the treatment phase, participants will be provided with all meals for the 35 day period. Breakfast meals will be consumed under the supervision of the research staff and lunch, dinner and snacks will be provided to take home in take-out packaging. While subjects are on the wash-out period they will return to their normal diet. The meals are on a 7 day rotating schedule that reflect an average Canadian diet. Changes in blood lipids, body weight, and waist circumference will be measured during each treatment phase. Cholesterol absorption and synthesis will be examined by stable isotope method. Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol. Fecal samples will be collected at the end of each intervention phase and will be subjected to Illumina sequencing of 16S rRNA genes.
- Conditions
- Hypercholesterolemia
- Being tested
- Control, 3g LMW beta-glucan, 5g LMW beta-glucan, 3g HMW beta-glucan
- Keywords
- Beta-Glucan, Barley, Molecular Weight, Viscosity, Cholesterol, Stable isotope, Gene-nutrient interaction, Gut microbiota
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Minimal beta-glucan
3g LMW beta-glucanDietary supplement
3grams beta-glucan
5g LMW beta-glucanDietary supplement
5 grams beta-glucan
3g HMW beta-glucanDietary supplement
3 grams of high molecular weight beta-glucan
| Study group | Role | What they receive |
|---|---|---|
| 5g LMW beta glucan | Experimental | 5 gram low molecular weight barley beta-glucan diet for 35 days Receives: Dietary Supplement: Control |
| 3g HMW beta glucan | Experimental | 3 gram high molecular weight barley beta-glucan diet for 35 days Receives: Dietary Supplement: 3g LMW beta-glucan |
| 3g LMW beta glucan | Experimental | 3 grams of low molecular weight beta-glucan diet for 35 days Receives: Dietary Supplement: 5g LMW beta-glucan |
| Control | Placebo comparator | control diet containing negligible amount of beta glucan Receives: Dietary Supplement: 3g HMW beta-glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changs in Total Cholesterol
Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Measured: Beginning and end of each phase
Changes in LDL Cholesterol
Serum LDL cholesterol will be estimated using the Friedewald equation.
Measured: Beginning and end of each phase
Secondary outcomes (3)
Cholesterol Absorption/Synthesis
The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.
Measured: End of each phase
Potential Gene-nutrient Interactions: CYP7A1 and APOE
The Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.
Measured: Once for each participant
Changes in Body Weight and Waist Circumference(WC)
Body weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.
Measured: Every day for body weight; beginning and end of each phase for WC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dr. Nancy Ames, University of Manitoba
- Investigators
- Nancy Ames, PhD, Principal investigator, AAFC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408719
- Sponsor's protocol ID
- B2010:216
- Status last verified
- Oct 2015
- First submitted
- 2 Aug 2011
- Last updated
- 5 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wang Y, Harding SV, Eck P, Thandapilly SJ, Gamel TH, Abdel-Aal el-SM, Crow GH, Tosh SM, Jones PJ, Ames NP. High-Molecular-Weight beta-Glucan Decreases Serum Cholesterol Differentially Based on the CYP7A1 rs3808607 Polymorphism in Mildly Hypercholesterolemic Adults. J Nutr. 2016 Apr;146(4):720-7. doi: 10.3945/jn.115.223206. Epub 2016 Mar 2.
PubMed 26936139
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
- ClinicalTrials.gov ID
- NCT01408719
- Acronym / sponsor ID
- B2010:216
- Conditions
- Hypercholesterolemia
- Keywords
- Beta-Glucan, Barley, Molecular Weight, Viscosity, Cholesterol, Stable isotope, Gene-nutrient interaction, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Posted 11 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed. Our second aim is to investigate the mechanism responsible for the action, specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet interactions are associated with cholesterol lowering by barley β-glucan. In addition, we aim to investigate the alteration of the gut microbiota after β-glucan consumption and the correlation between the altered gut microbiota and cardiovascular disease risk factors.
Detailed description
This study consists of four dietary phases which are separated by >28 days wash-out period. During the treatment phase, participants will be provided with all meals for the 35 day period. Breakfast meals will be consumed under the supervision of the research staff and lunch, dinner and snacks will be provided to take home in take-out packaging. While subjects are on the wash-out period they will return to their normal diet. The meals are on a 7 day rotating schedule that reflect an average Canadian diet. Changes in blood lipids, body weight, and waist circumference will be measured during each treatment phase. Cholesterol absorption and synthesis will be examined by stable isotope method. Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol. Fecal samples will be collected at the end of each intervention phase and will be subjected to Illumina sequencing of 16S rRNA genes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5g LMW beta glucan | Experimental | Dietary Supplement: Control5 gram low molecular weight barley beta-glucan diet for 35 days |
| 3g HMW beta glucan | Experimental | Dietary Supplement: 3g LMW beta-glucan3 gram high molecular weight barley beta-glucan diet for 35 days |
| 3g LMW beta glucan | Experimental | Dietary Supplement: 5g LMW beta-glucan3 grams of low molecular weight beta-glucan diet for 35 days |
| Control | Placebo comparator | Dietary Supplement: 3g HMW beta-glucancontrol diet containing negligible amount of beta glucan |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 20-40 kg/m2
- Fasting cholesterol levels of 5.0-8.0 mmol/L
- Fasting serum LDL cholesterol levels of 2.7-5.0 mmol/L
Key exclusion criteria (4 listed)
- Pregnant or lactating
- Taking lipid lowering medication or nutritional supplements that affect blood lipids
- Dietary restrictions which would affect consuming the study diet for 5-wk for four study phases.
- Not deemed healthy by study physician
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 |
|---|---|---|
| ControlMinimal beta-glucan | Dietary supplement | 5g LMW beta glucan |
| 3g LMW beta-glucan3grams beta-glucan | Dietary supplement | 3g HMW beta glucan |
| 5g LMW beta-glucan5 grams beta-glucan | Dietary supplement | 3g LMW beta glucan |
| 3g HMW beta-glucan3 grams of high molecular weight beta-glucan | Dietary supplement | Control |
Primary outcome
Changs in Total Cholesterol
Time frame: Beginning and end of each phase
Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Changes in LDL Cholesterol
Time frame: Beginning and end of each phase
Serum LDL cholesterol will be estimated using the Friedewald equation.
3 secondary outcomes
Cholesterol Absorption/Synthesis
Time frame: End of each phase
Potential Gene-nutrient Interactions: CYP7A1 and APOE
Time frame: Once for each participant
Changes in Body Weight and Waist Circumference(WC)
Time frame: Every day for body weight; beginning and end of each phase for WC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26936139Wang Y, Harding SV, Eck P, Thandapilly SJ, Gamel TH, Abdel-Aal el-SM, Crow GH, Tosh SM, Jones PJ, Ames NP. High-Molecular-Weight beta-Glucan Decreases Serum Cholesterol Differentially Based on the CYP7A1 rs3808607 Polymorphism in Mildly Hypercholesterolemic Adults. J Nutr. 2016 Apr;146(4):720-7. doi: 10.3945/jn.115.223206. Epub 2016 Mar 2.
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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.
Nancy Ames, PhD principal investigator
AAFC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3g LMW beta-glucan, 5g LMW beta-glucan and 3g HMW beta-glucan in people with Hypercholesterolemia, run by University of Manitoba 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 3 inclusion and 4 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 5 Nov 2015. 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. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changs in Total Cholesterol (time frame: Beginning and end of each phase). The study lists 2 primary outcomes in all. 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 NCT01408719, 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 5 Nov 2015.