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

Atherosclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03313713
• Other study ID #: BELT_2016
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 8, 2017
• Last updated: October 17, 2017
• Start date: April 26, 2017
• Est. completion date: March 2018

Study information

• Verified date: October 2017
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 85
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Dietary Supplement:
• Beta-glucans
Placebo consumption at breakfast (3 g per day)
• Placebo
Placebo consumption at breakfast (3 g per day)

Locations

Country	Name	City	State
Italy	S. Orsola-Malpighi University Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 hour fasting lipid profile change from the baseline to the end of the intervention period		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)
Primary	12 hour fasting glycemia change from the baseline to the end of the intervention period		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	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.	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	Liver function markers (glutamic oxalacetic transaminase, alanine transaminase, glutamic-pyruvic transaminase, aspartate transaminase) change from the baseline to the end of the intervention period		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	Blood pressure change from the baseline to the end of the intervention period		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)