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

NCT02041104 | Completed Results

• 1 other identifier: MLINOTEST/618-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Metabolic syndrome; 4 -week intervention; Randomised placebo controlled parallel study; Beta-glucans; Abdominal fat; Dyslipidemia; Insulin resistance; Hypertension; Gut Microbiota Composition; Oral Glucose Tolerance Test; Lipid Profile; Real-Time Polymerase Chain Reaction; Denaturating Gradient Gel Electrophoresis

Outcome Measures

Primary Outcomes (9)

• Total Cholesterol Levels

  Before the intervention, total cholesterol levels were determined.

  Baseline outcome measurement

• HDL-cholesterol Levels

  HDL-cholesterol levels were determined before diet intervention.

  Baseline measurement

• LDL-cholesterol Levels

  LDL-cholesterol levels were determined before intervention

  Baseline measurement

• Determination of Composition of Intestinal Microbiota From Fecal Samples

  Fecal sampling for microbiologic analysis of microbiota composition: Composition of intestinal microbiota will be determined with a combination of two molecular techniques denaturating gradient gel electrophoresis (DGGE) and quantitative real time PCR (RT-PCR).

  Outcome measurement at baseline

• Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)

  Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma insulin concentrations were measured at following times: 0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose

  OGTT measurements performed before dietary intervention

• Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)

  Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma glucose concentrations were measured at following times: 0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose

  Outcome OGTT measurements performed before dietary intervention

• Systolic and Diastolic Blood Pressure

  Before the intervention, systolic and diastolic blood pressure were measured. Measurement was performed to obtain parameters for metabolic syndrome definition. Measurements after dietary intervention weren't performed.

  Outcome measurement at baseline.

• Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples

  Fecal sampling for SCFA determination: Content of specific SCFA (butyric acid, acetic acid and propionic acid) will be determined in fecal samples using Gas Chromatography.

  Outcome measurement at baseline

• Triglyceride Levels

  Before the diet intervention, triglyceride levels were measured in test (consuming bread with added beta glucans) and in control group (consuming bread without added beta glucans).

  Outcome measure at baseline.

Secondary Outcomes (8)

• Determination of Composition of Intestinal Microbiota From Fecal Samples

  Outcome measurement after 4-week dietary intervention

• Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples

  Outcome measurement after 4-week dietary intervention

• LDL-cholesterol Levels

  Outcome measurement after 4-week dietary intervention

• HDL-cholesterol Levels

  Outcome measurement after 4-week dietary intervention

• Triglyceride Levels

  Outcome measure after 4-week dietary intervention.

Study Arms (2)

Bread with added beta-glucans

EXPERIMENTAL

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.

Dietary Supplement: Bread with added beta-glucans

Bread without added beta-glucans

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Comparator: Bread without added beta-glucans

Interventions

Bread with added beta-glucans 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 with added beta-glucans

Placebo Comparator: Bread without added beta-glucans 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.

Bread without added beta-glucans

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mlinotest Zivilska Industrija d.d.: lead
• University of Ljubljana: collaborator
• University Medical Centre Ljubljana: collaborator

Study Sites (3)

Community Health Center Ajdovscina

Ajdovščina, 5270, Slovenia

Location

Community Healt Center Ljubljana

Ljubljana, 1000, Slovenia

Location

Community Health Center Franca Amrozica Postojna

Postojna, 6230, Slovenia

Location

Related Publications (1)

• (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

  BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Dyslipidemias; Obesity, Abdominal; Hyperglycemia; Hypertension; Insulin Resistance

Interventions

Bread

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Ana Velikonja
• Organization: Mlinotest d. d.

anaa.velikonja@gmail.com

0038651321785

Study Officials

• Ana Velikonja, PhD student

  Mlinotest d.d. Zivilska Industrija

  PRINCIPAL INVESTIGATOR

• Rok Orel, M.D., D.Sc.

  University Medical Centre Ljubljana

  STUDY DIRECTOR

• Gorazd Avgustin, UP

  University of Ljubljana

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 20, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Locations

SL (3)