NCT02041104

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

Completed NA Results posted Last updated 21 February 2019

What this trial tests

NA trial testing Bread with added beta-glucans in Metabolic Syndrome in 51 participants. Completed in 1 April 2018.

Timeline

1 February 2014

Primary endpoint
1 April 2018

1 April 2018

Quick facts

Lead sponsor	Mlinotest Zivilska Industrija d.d.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	51
Start date	1 February 2014
Primary completion	1 April 2018
Estimated completion	1 April 2018
Sites	3 locations across Slovenia

Drugs / interventions tested

• Bread with added beta-glucans
• Placebo Comparator: Bread without added beta-glucans

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Dyslipidemia — all drugs for Dyslipidemia →
• Obesity, Abdominal — all drugs for Obesity, Abdominal →
• Hyperglycemia — all drugs for Hyperglycemia →

Sponsor

Mlinotest Zivilska Industrija d.d.

Who can join

Adults 30 to 70, any sex, with Metabolic Syndrome or Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application.
   Murphy EJ, Rezoagli E, Major I, Rowan NJ, et al · · 2020 · cited 121× · PMID 33322069 · DOI 10.3390/jof6040356
2. Human gut microbiome: Therapeutic opportunities for metabolic syndrome-Hype or hope?
   Horvath A, Zukauskaite K, Hazia O, Balazs I, et al · · 2024 · cited 15× · PMID 37771199 · DOI 10.1002/edm2.436