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

NCT03313713 | Unknown DMC

• 1 other identifier: BELT_2016
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Intestinal function 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)

• 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)

Study Arms (2)

Beta-glucans

ACTIVE COMPARATOR

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

Dietary Supplement: Beta-glucans

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Beta-glucans DIETARY_SUPPLEMENT

Placebo consumption at breakfast (3 g per day)

Beta-glucans

Placebo DIETARY_SUPPLEMENT

Placebo consumption at breakfast (3 g per day)

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Officials

• Claudio Borghi, MD

  S. Orsola-Malpighi University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Internal Medicine Unit

Study Record Dates

• First Submitted: October 8, 2017
• First Posted: October 18, 2017
• Study Start: April 26, 2017
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

IT (1)