Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT02041104
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:
NCT02041104
Study Brief:
Protocol Section:
NCT02041104