AtherosclerosisBELTNCT03313713
Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT)
A study testing Beta-glucans in people with Atherosclerosis, run by University of Bologna at 1 site in Italy.
Trial summary
This will be a randomized, placebo-controlled, clinical trial carried out on moderately hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to evaluate the effects on lipid profile, glycemia and intestinal function Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Beta-glucans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2017to Mar 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total cholesterol between 200 and 240 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL
- Triglycerides lower than 200 mg/dL
- Cardiovascular risk at 10 years lower than 10%
- Informed consent
Who cannot join
- Secondary prevention for cardiovascular diseases
- TG > 400 mg/dL, HDL-C < 35 mg/dL
- BMI higher than 30
- Assumption of lipid lowering drug or supplement with fibre or probiotics during the last 2 months
- Alcohol abuse
- Food allergy
- Alterations in thyroid, liver, or kidney functions, muscle diseases
- Diabetes, irritable bowel syndrome or chronic disturbed gut function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Placebo-Controlled Clinical Trial to Assess the Medium-term Effect of 3 g/Day of a Beta-glucan on Lipid Profile, Glycemia and Intestinal Health, in Moderately Hypercholesterolemic Subjects
This will be a randomized, placebo-controlled, clinical trial carried out on moderately hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to evaluate the effects on lipid profile, glycemia and intestinal function
Read the detailed description
In order to assess the mid term effects of beta-glucans on lipid profile, glycemia and intestinal function, moderately hypercholesterolemic subjects will be involved in a cross-over study and supplemented for 8 weeks with 3 g/day of beta-glucans or placebo. The two intervention periods will be spaced by a 4 week washout period
- Conditions
- Atherosclerosis
- Being tested
- Beta-glucans, Placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-glucansDietary supplement
Placebo consumption at breakfast (3 g per day)
PlaceboDietary supplement
Placebo consumption at breakfast (3 g per day)
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucans | Active comparator | Beta-glucans, 3 g per day, per 8 weeks, at breakfast Receives: Dietary Supplement: Beta-glucans |
| Placebo | Placebo comparator | Placebo, 3 g per day, per 8 weeks, at breakfast Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 hour fasting lipid profile change from the baseline to the end of the intervention period
Measured: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
12 hour fasting glycemia change from the baseline to the end of the intervention period
Measured: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
Secondary outcomes (3)
Intestinal function from the baseline to the end of the intervention period
Intestinal function will be assessed by the use of a scale questionnaire investigating the number of weekly bowel movements, stool consistency, ease of defecation, sensation of emptying after defecation, intensity of discomfort during the defecation, feeling of bloating.
Measured: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
Liver function markers (glutamic oxalacetic transaminase, alanine transaminase, glutamic-pyruvic transaminase, aspartate transaminase) change from the baseline to the end of the intervention period
Measured: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
Blood pressure change from the baseline to the end of the intervention period
Measured: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start26 Apr 2017
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
- Investigators
- Claudio Borghi, MD, Principal investigator, S. Orsola-Malpighi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313713
- Sponsor's protocol ID
- BELT_2016
- Acronym
- BELT
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo-Controlled Clinical Trial to Assess the Medium-term Effect of 3 g/Day of a Beta-glucan on Lipid Profile, Glycemia and Intestinal Health, in Moderately Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT03313713
- Acronym / sponsor ID
- BELT / BELT_2016
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 18 Oct 2017 (actual)
- 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.
This will be a randomized, placebo-controlled, clinical trial carried out on moderately hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to evaluate the effects on lipid profile, glycemia and intestinal function
Detailed description
In order to assess the mid term effects of beta-glucans on lipid profile, glycemia and intestinal function, moderately hypercholesterolemic subjects will be involved in a cross-over study and supplemented for 8 weeks with 3 g/day of beta-glucans or placebo. The two intervention periods will be spaced by a 4 week washout period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-glucans | Active comparator | Dietary Supplement: Beta-glucansBeta-glucans, 3 g per day, per 8 weeks, at breakfast |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, 3 g per day, per 8 weeks, at breakfast |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Total cholesterol between 200 and 240 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL
- Triglycerides lower than 200 mg/dL
- Cardiovascular risk at 10 years lower than 10%
- Informed consent
Key exclusion criteria (8 listed)
- Secondary prevention for cardiovascular diseases
- TG > 400 mg/dL, HDL-C < 35 mg/dL
- BMI higher than 30
- Assumption of lipid lowering drug or supplement with fibre or probiotics during the last 2 months
- Alcohol abuse
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 |
|---|---|---|
| Beta-glucansPlacebo consumption at breakfast (3 g per day) | Dietary supplement | Beta-glucans |
| PlaceboPlacebo consumption at breakfast (3 g per day) | Dietary supplement | Placebo |
Primary outcome
12 hour fasting lipid profile change from the baseline to the end of the intervention period
Time frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
12 hour fasting glycemia change from the baseline to the end of the intervention period
Time frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
3 secondary outcomes
Intestinal function from the baseline to the end of the intervention period
Time frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
Liver function markers (glutamic oxalacetic transaminase, alanine transaminase, glutamic-pyruvic transaminase, aspartate transaminase) change from the baseline to the end of the intervention period
Time frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
Blood pressure change from the baseline to the end of the intervention period
Time frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- 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.
Claudio Borghi, MD principal investigator
S. Orsola-Malpighi University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-glucans in people with Atherosclerosis, run by University of Bologna at 1 site in Italy.
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 8 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 19 Oct 2017. 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 Italy. 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?
12 hour fasting lipid profile change from the baseline to the end of the intervention period (time frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)). 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?
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 19 Oct 2017.