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

Hypertension Clinical Trial

Official title:

Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism in a Population With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041104
• Other study ID #: MLINOTEST/618-001
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: April 2018

Study information

• Verified date: February 2019
• Source: Mlinotest Zivilska Industrija d.d.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria are parameters used for metabolic syndrome determination according to International Diabetes Federation (IDF) consensus worldwide definition of Metabolic Syndrome:

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hyperglycemia
• Hypertension
• Metabolic Syndrome
• Obesity, Abdominal
• Syndrome

Intervention

Dietary Supplement:
• 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
• 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.

Locations

Country	Name	City	State
Slovenia	Community Health Center Ajdovscina	Ajdovscina
Slovenia	Community Healt Center Ljubljana	Ljubljana
Slovenia	Community Health Center Franca Amrozica Postojna	Postojna

Sponsors (3)

Lead Sponsor	Collaborator
Mlinotest Zivilska Industrija d.d.	University Medical Centre Ljubljana, University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol Levels	Before the intervention, total cholesterol levels were determined.	Baseline outcome measurement
Primary	HDL-cholesterol Levels	HDL-cholesterol levels were determined before diet intervention.	Baseline measurement
Primary	LDL-cholesterol Levels	LDL-cholesterol levels were determined before intervention	Baseline measurement
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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
Primary	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	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 after 4-week dietary intervention
Secondary	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 after 4-week dietary intervention
Secondary	LDL-cholesterol Levels	LDL-cholesterol levels were determined after intervention	Outcome measurement after 4-week dietary intervention
Secondary	HDL-cholesterol Levels	HDL-cholesterol levels were determined after diet intervention.	Outcome measurement after 4-week dietary intervention
Secondary	Triglyceride Levels	After 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 after 4-week dietary intervention.
Secondary	Total Cholesterol Levels	After the intervention, total cholesterol levels were determined.	Outcome measurement after 4-week dietary intervention
Secondary	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 concentration measurements were performed 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 after 4-week dietary intervention
Secondary	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 concentration measurements were performed 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 after 4-week dietary intervention

External Links

•   International Diabetes Federation (IDF) consensus worldwide definition of Metabolic Syndrome