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

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

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis
• Intervention / Treatment: Dietary supplement: Beta-glucans; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • S. Orsola-Malpighi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Beta-glucans; Beta-glucans, 3 g per day, per 8 weeks, at breakfast	Dietary supplement: Beta-glucans; Placebo consumption at breakfast (3 g per day)
PLACEBO_COMPARATOR: Placebo; Placebo, 3 g per day, per 8 weeks, at breakfast	Dietary supplement: Placebo; Placebo consumption at breakfast (3 g per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2017
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: October 8, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (ACTUAL): October 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: BELT_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No