Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism

NCT ID: NCT02041104

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2018-04-30

Brief Summary

The purpose of this study is to investigate if daily consumption of barley beta-glucans effect lipid and glucose metabolism and alter intestinal microbiota composition in participants with metabolic syndrome or with high risk for metabolic syndrome development. It is assumed that 4-week intervention with beta-glucans will improve some clinical signs of metabolic syndrome and alter composition of intestinal microbiota. Variation in microbiota composition will be investigated with emphasis on Bacteroidetes and Firmicutes ratio. Furthermore it is presupposed that consumption of beta-glucans will stimulate growth of beneficial intestinal bacteria from genus Lactobacillus and Bifidobacteria and consequently effect production of short chain fatty acids in population with metabolic syndrome. Moreover it is presupposed that 4-week consumption of beta-glucans will have influence on glucose metabolism and will consequently improve insulin resistance within people with metabolic syndrome or high risk for metabolic syndrome development. It is assumed that 4-week consumption of beta-glucans will improve specific plasma lipid content in population with metabolic syndrome.

Detailed Description

In study it will be investigated whether daily consumption of barley beta-glucans integrated in bread product effects lipid and glucose metabolism and alter the composition of intestinal microbiota in a population with metabolic syndrome or with high risk for metabolic syndrome development. 70 participants with metabolic syndrome will be enrolled in study. Participants will daily consume 200 g of bread with high amount of beta-glucans.

Hypothesis:

1. 4- week consumption of beta-glucans alters composition of intestinal microbiota and changes ratio of bacteria from phylum Bacteroidetes and Firmicutes. Furthermore consumption of beta-glucans stimulates growth of beneficial intestinal bacteria from genus Lactobacillus and Bifidobacteria and consequently effects production of short chain fatty acids in population with metabolic syndrome.

2. 4- week consumption of beta-glucans has influence on glucose metabolism and consequently improves insulin resistance within people with metabolic syndrome.

3. 4 - week consumption of beta-glucans improves specific plasma lipid content in population with metabolic syndrome.

Study will be designed as double blind, randomised, placebo controlled clinical trial and performed regarding to CONSORT 2010 recommendations for randomised clinical trials. Patient enrollment will be performed in several community health centres in Slovenia in association with family medicine doctors. Appropriate patients with metabolic syndrome or with high risk for metabolic development will be suggested to participate in clinical trial. Candidates will be suggested to participate in a two month study. If there will not be recruited enough participants for two month study they will be suggested for participation in one month study. Candidates interested in participating in study will be informed about study design and terms and conditions of study by main investigator.

Study will be performed after successful recruitment of first 20 or more participants. Study will be performed three times, so that 70 participants will be recruited in complete study. Participants will consume bread with high beta-glucans content (around 3, 4 g beta-glucans per 100 g of bread) during 8 or 4 week period. Before beginning of study participants will have two week washout period without consuming any pre- and pro-biotics. They will remain their usual eating habits during study period except taking any antibiotics or pre- and pro-biotic. Participants will give blood and stool samples a day before intervention with barley beta-glucans. Blood sampling will involve oral glucose test for insulin resistance determination and sampling for specific lipid content determination. They will also have option to give a blood sample for genetic investigation of genes associated with lipid metabolism (apoE). Blood and stool sampling will be repeated day after intervention period. The same parameters as before intervention period except genetic analysis will be investigated. 72-hour dietary recall will be performed during intervention period individually to evaluate daily nutrient and energetic input of each participant.

Conditions

Metabolic Syndrome; Dyslipidemia; Obesity, Abdominal; Hyperglycemia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bread with added beta-glucans

Experimental food is bread with high amount of barley beta-glucans. Experimental bread contains approximately 3,4 % (w/w) beta-glucans. Participants will consume 6 g of beta-glucans daily (approximately 200 g of bread per day). Beta-glucans are natural polysaccharides found in grain endosperm and are mostly represented in oat and barley. Beta-glucans are linear homopolymers of D- glycopyranosyl residues with mixed linkage (1-4, 1-3)-β-D-glucans. Their molecular structure enable beta-glucans their functional action that mostly depends of their viscosity and solubility (1). Testing bread has integrated flour with high amount of barley beta-glucans (ReducholTM). Beta-glucans are concentrated in flour up to 15 % with dry milling, sieving and air classification of barley flour.

Group Type: EXPERIMENTAL

Bread with added beta-glucans

Intervention Type: DIETARY_SUPPLEMENT

Participants will daily consume bread with high content of beta-glucans. They will approximately consume 6 g beta-glucans per day in 200 g of bread. Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics

Bread without added beta-glucans

Placebo bread without added barley beta-glucans in testing product.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator: Bread without added beta-glucans

Intervention Type: DIETARY_SUPPLEMENT

Participants will daily consume placebo bread without any added beta-glucans (approximately 200 g per day). Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Interventions

Bread with added beta-glucans

Participants will daily consume bread with high content of beta-glucans. They will approximately consume 6 g beta-glucans per day in 200 g of bread. Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator: Bread without added beta-glucans

Participants will daily consume placebo bread without any added beta-glucans (approximately 200 g per day). Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Participant must have central obesity: defined as waist circumference ≥ 80 cm for European woman and ≥ 94 cm for European men. Beside central obesity candidates participating in this study must have total cholesterol concentration ≥ 5 mmol/l before entering the study.

Plus any two of the following four factors:

• HDL-cholesterol content: man ≤ 1,03 mmol/, women ≤ 1,23 mmol/l
• Triglycerides content ≥ 1,7 mmol/l
• Fasting blood glucose ≥ 5,6 mmol/l
• Hypertension: systolic blood pressure ≥ 130 mm Hg and diastolic blood pressure ≥ 85 mm Hg

If participant will have diagnosed metabolic syndrome and meet age criteria will be included in study.

Exclusion Criteria

• Diabetes type II
• Thyroid disorder
• Kidney disorder
• Antibiotic treatment

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: collaborator

Mlinotest Zivilska Industrija d.d.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Velikonja, PhD student

Role: PRINCIPAL_INVESTIGATOR

Mlinotest d.d. Zivilska Industrija

Rok Orel, M.D., D.Sc.

Role: STUDY_DIRECTOR

University Medical Centre Ljubljana

Gorazd Avgustin, UP

Role: STUDY_DIRECTOR

University of Ljubljana

Locations

Community Health Center Ajdovscina

Ajdovščina, , Slovenia

Community Healt Center Ljubljana

Ljubljana, , Slovenia

Community Health Center Franca Amrozica Postojna

Postojna, , Slovenia

Countries

Slovenia

References

(1) Izydorczyk MS,Dexter JE. Barley beta-glucans and arabinoxylans: Molecular structure, physicochemical properties, and uses in food products-a Review. Food Research International 41: 850-868, 2008

Reference Type: BACKGROUND

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

MLINOTEST/618-001

Identifier Type: -

Identifier Source: org_study_id