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Trial record 10 of 20 for:    LDL- | barley

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

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ClinicalTrials.gov Identifier: NCT02041104
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
University of Ljubljana
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Mlinotest Zivilska Industrija d.d.

Tracking Information
First Submitted Date  ICMJE January 15, 2014
First Posted Date  ICMJE January 20, 2014
Results First Submitted Date  ICMJE May 15, 2018
Results First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Study Start Date  ICMJE February 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Total Cholesterol Levels [ Time Frame: Baseline outcome measurement ]
    Before the intervention, total cholesterol levels were determined.
  • HDL-cholesterol Levels [ Time Frame: Baseline measurement ]
    HDL-cholesterol levels were determined before diet intervention.
  • LDL-cholesterol Levels [ Time Frame: Baseline measurement ]
    LDL-cholesterol levels were determined before intervention
  • Determination of Composition of Intestinal Microbiota From Fecal Samples [ Time Frame: Outcome measurement at baseline ]
    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).
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) [ Time Frame: OGTT measurements performed before dietary intervention ]
    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
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) [ Time Frame: Outcome OGTT measurements performed before dietary intervention ]
    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
  • Systolic and Diastolic Blood Pressure [ Time Frame: Outcome measurement at baseline. ]
    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.
  • Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples [ Time Frame: Outcome measurement at baseline ]
    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.
  • Triglyceride Levels [ Time Frame: Outcome measure at baseline. ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
  • Lipid profile [ Time Frame: Change outcome measurement at baseline ]
    "Change" outcome measurement: Before intervention period following lipid parameters will be determined: content of total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol
  • Genetic analysis [ Time Frame: Outcome measurment at baseline ]
    Genetic analysis is not obligatory for participants included in study. After enrollment in study they will be suggested to give blood sample (5 mL) for genetic analysis. Genetic analysis: Common single nucleotide polymorphism (SNP) in APOE gene.
  • Determination of Composition of Intestinal Microbiota From Fecal Samples [ Time Frame: Change outcome measurement at baseline ]
    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).
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) [ Time Frame: Change outcome measurement at baseline ]
    Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. After oral consumption of 75 g of glucose we will measure plasma insulin concentration in following intervals: 0 min, 60 min, 90 min and 120 min.
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) [ Time Frame: Change outcome measurement at baseline ]
    Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. After oral consumption of 75 g of glucose we will measure plasma glucose concentration in following intervals: 0 min, 60 min, 90 min and 120 min.
  • Systolic / diastolic blood pressure [ Time Frame: Change outcome measurement at baseline ]
    "Change" outcome measurement: Before intervention period systolic and diastolic blood pressure will be measured.
  • Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples [ Time Frame: Change outcome measurement at baseline ]
    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.
Change History Complete list of historical versions of study NCT02041104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Determination of Composition of Intestinal Microbiota From Fecal Samples [ Time Frame: Outcome measurement after 4-week dietary intervention ]
    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).
  • Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples [ Time Frame: Outcome measurement after 4-week dietary intervention ]
    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.
  • LDL-cholesterol Levels [ Time Frame: Outcome measurement after 4-week dietary intervention ]
    LDL-cholesterol levels were determined after intervention
  • HDL-cholesterol Levels [ Time Frame: Outcome measurement after 4-week dietary intervention ]
    HDL-cholesterol levels were determined after diet intervention.
  • Triglyceride Levels [ Time Frame: Outcome measure after 4-week dietary intervention. ]
    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).
  • Total Cholesterol Levels [ Time Frame: Outcome measurement after 4-week dietary intervention ]
    After the intervention, total cholesterol levels were determined.
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) [ Time Frame: Outcome OGTT measurements performed after 4-week dietary intervention ]
    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
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) [ Time Frame: Outcome OGTT measurements performed after 4-week dietary intervention ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
  • Lipid profile [ Time Frame: Chance outcome measurement at 8 weeks ]
    "Change" outcome measurement: Before intervention period following lipid parameters will be determined: content of total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol
  • Determination of Composition of Intestinal Microbiota From Fecal Samples [ Time Frame: Change outcome measurement at 8 weeks ]
    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).
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) [ Time Frame: Change outcome measurement at 8 weeks ]
    Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. After oral consumption of 75 g of glucose we will measure plasma insulin concentration in following intervals: 0 min, 60 min, 90 min and 120 min.
  • Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) [ Time Frame: Change outcome measurement at 8 weeks ]
    Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. After oral consumption of 75 g of glucose we will measure plasma glucose concentration in following intervals: 0 min, 60 min, 90 min and 120 min.
  • Systolic / diastolic Blood pressure [ Time Frame: Chance outcome measurement at 8 weeks ]
    "Change" outcome measurement: Before intervention period systolic and diastolic blood pressure will be measured.
  • Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples [ Time Frame: Change outcome measurement at 8 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism
Official Title  ICMJE Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism in a Population With Metabolic Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Syndrome
  • Dyslipidemia
  • Obesity, Abdominal
  • Hyperglycemia
  • Hypertension
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: Bread with added beta-glucans
  • Placebo Comparator: Bread without added beta-glucans
    Placebo bread without added barley beta-glucans in testing product.
    Intervention: Dietary Supplement: Placebo Comparator: Bread without added beta-glucans
Publications * (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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2019)
51
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2014)
70
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02041104
Other Study ID Numbers  ICMJE MLINOTEST/618-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mlinotest Zivilska Industrija d.d.
Study Sponsor  ICMJE Mlinotest Zivilska Industrija d.d.
Collaborators  ICMJE
  • University of Ljubljana
  • University Medical Centre Ljubljana
Investigators  ICMJE
Principal Investigator: Ana Velikonja, PhD student Mlinotest d.d. Zivilska Industrija
Study Director: Rok Orel, M.D., D.Sc. University Medical Centre Ljubljana
Study Director: Gorazd Avgustin, UP University of Ljubljana
PRS Account Mlinotest Zivilska Industrija d.d.
Verification Date February 2019

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