search
Back to results

Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT) (BELT)

Primary Purpose

Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Beta-glucans
Placebo
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • S. Orsola-Malpighi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Beta-glucans

Placebo

Arm Description

Beta-glucans, 3 g per day, per 8 weeks, at breakfast

Placebo, 3 g per day, per 8 weeks, at breakfast

Outcomes

Primary Outcome Measures

12 hour fasting lipid profile change from the baseline to the end of the intervention period
12 hour fasting glycemia change from the baseline to the end of the intervention period

Secondary Outcome Measures

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.
Liver function markers (glutamic oxalacetic transaminase, alanine transaminase, glutamic-pyruvic transaminase, aspartate transaminase) change from the baseline to the end of the intervention period
Blood pressure change from the baseline to the end of the intervention period

Full Information

First Posted
October 8, 2017
Last Updated
October 17, 2017
Sponsor
University of Bologna
search

1. Study Identification

Unique Protocol Identification Number
NCT03313713
Brief Title
Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT)
Acronym
BELT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beta-glucans
Arm Type
Active Comparator
Arm Description
Beta-glucans, 3 g per day, per 8 weeks, at breakfast
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 3 g per day, per 8 weeks, at breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-glucans
Intervention Description
Placebo consumption at breakfast (3 g per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo consumption at breakfast (3 g per day)
Primary Outcome Measure Information:
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
Intestinal function from the baseline to the end of the intervention period
Description
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.
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Borghi, MD
Organizational Affiliation
S. Orsola-Malpighi University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
S. Orsola-Malpighi University Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT)

We'll reach out to this number within 24 hrs