Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism in a Population With Metabolic Syndrome
Phase: NA
Conditions: Metabolic Syndrome, Dyslipidemia, Obesity, Abdominal, Hyperglycemia, Hypertension
Sponsor: Mlinotest Zivilska Industrija d.d.

 
 
Study protocol version #1 (22/8/2013), English version #1 (21/2/2019) 
 
Impact of Consumption of Beta-glucans on the Intestinal Microbiota and 
Glucose and Lipid Metabolism 
 
 
ClinicalTrials.gov registration number: NCT02041104 
 
 
Study performed by: 
Ana Velikonjaa, Luka Lipoglavšekb, Rok Orelc, Gorazd Avguštinb* 
 
a Mlinotest d.d., Tovarniška cesta 14, SI-5270 Ajdovščina, Slovenia 
b University of Ljubljana, Biotechnical Faculty, Department of Animal Science, Groblje 3, SI-1230 Domžale, 
Slovenia 
c University Medical Centre Ljubljana, University Children`s Hospital, Department of Gastroenterology, 
Hepatology and Nutrition, Bohoričeva 20, SI-1000 Ljubljana, Slovenia 
 
 
Study was sponsored by the company Mlinotest d.d., Ajdovščina, Slovenia and by the 
research programme P4-0097 of the Slovenian Research Agency 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL: »Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid 
Metabolism«  
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STUDY PROTOCOL 
 »Impact of Consumption of Beta-glucans on the Intestinal Microbiota and 
Glucose and Lipid Metabolism« 
 
Introduction 
Metabolic syndrome (MS) is a complex lifestyle disease manifesting metabolic disorders 
such as abdominal obesity, dyslipidemia, hyperglycemia and hypertension. There are many 
studies reporting how gut microbiota correlates with metabolic disorders or contributes to the 
development of obesity trough increased energy harvest. An increasing interest in finding the 
diet that could regulate the composition of gut microbiota and consequently improve the 
individual conditions related to some of the metabolic disorders, exists. The aim of our study 
will be to investigate, whether consumption of barley beta glucans can positively modulate 
the composition of gut microbiota and metabolic parameters related to MS. Barley beta 
glucans are polysaccharides found in kernel endosperm and improve both lipid and glucose 
metabolism. The effects of barley beta glucans on gut microbiota composition are still poorly 
investigated in human clinical trials. 
We will perform a double-blind, placebo controlled, randomized clinical trial with volunteers 
diagnosed with MS. The exact study protocol and procedure will be explained to the 
participants, who will meet inclusion criteria. After assignment of participation agreement, 
participant will be randomized and allocated to test or placebo group. Before and after the 
dietary intervention, anthropometric measurements, blood analysis, including oral glucose 
tolerance testing (OGTT), and fecal sampling will be performed. Participants will daily 
complete food frequency questionnaire and detailed 72-hour dietary recall. During 
intervention participants will daily consumed test bread with added 6g beta glucans or bread 
without added beta-glucans.  
The study was approved by the Republic of Slovenia National Medical Ethics Committee 
(112/08/13).  
 
 
 
 
 
 

STUDY PROTOCOL: »Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid 
Metabolism«  
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Study protocol 
 
A) Participants information and inclusion criteria 
 
Name 
 
Surname 
 
Age 
 
Body height & body weight (cm, kg) 
 
Diabetes type 2 
 
Kidney disfunction 
 
Thyroid disfunction 
 
Treatment for hypercholesterolemia (not 
hypertension) 
 
Total cholesterol (mmol /l) 
 
Body Mass Index (BMI) 
 
 
B) Before and after intervention: Blood test Analysis and Anthropometric 
measurements 
 
1. Lipid profile, Anthropometric measurements 
Parameter 
Before dietary intervention 
After dietary intervention 
Total cholesterol (mmol/l) 
 
 
LDL-cholesterol (mmol/l) 
 
 
HDL-cholesterol (mmol/l) 
 
 
Triglycerides (mmol/l) 
 
 
Blood pressure (mmHg) 
 
/ 
Body weight (kg) 
 
 
Body waist (cm) 
 
 
 
 
 
 

STUDY PROTOCOL: »Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid 
Metabolism«  
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2. Oral glucose tolerance test (OGTT) 
Sampling 
time after 
glucose 
consumption 
(min) 
Before dietary intervention 
After dietary intervention 
Glucose level 
(mmol/l) 
Insulin level 
(µU/ml) 
Glucose level 
(mmol/l) 
Insulin level 
(µU/ml) 
0 
 
 
 
 
30 
 
 
 
 
60 
 
 
 
 
120 
 
 
 
 
 
3. Gut microbiota analysis and short chain fatty acids measurements 
Faecal samples will be obtained before and after dietary intervention.  
Analysis of gut microbiota composition will be performed followed DNA extraction, with 
several methodologies; Denaturing Gradient Gel Electrophoresis (DGGE), qPCR, new 
generation sequencing (illumine Miseq platform). 
Short-chain fatty acids determination 
 
Short-chain fatty acid 
Before dietary intervention 
(g/kg) 
After dietary intervention 
(g/kg) 
Butyric acid 
 
 
Acetic acid 
 
 
Propionic acid 
 
 
 
 
 
 
 

STUDY PROTOCOL: »Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid 
Metabolism«  
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4. 72-hour dietary recall 
Dietary recall will be performed three times before and during dietary intervention to 
obtain average nutrient intake: 
 
Average nutrition intake 
per 100 g 
Before dietary 
intervention 
Between dietary 
intervention 
Energy (kcal) 
 
 
Protein (g) 
 
 
Fat (g) 
 
 
Total carbohydrates (g) 
 
 
Total dietary fibre (g) 
 
 
Water (g)