N/A
N=51
Impact of Consumption of Beta-glucans on the Intestinal Microbiota and Glucose and Lipid Metabolism
Metabolic Syndrome · Dyslipidemia · Obesity, Abdominal · Hyperglycemia · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02041104 ↗Enrolled (actual)
51
Serious AEs
7.8%
Results posted
Jun 2019
Primary outcome: Primary: Total Cholesterol Levels — 5.8; 5.9 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bread with added beta-glucans (Dietary_supplement); Placebo Comparator: Bread without added beta-glucans (Dietary_supplement)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Mlinotest Zivilska Industrija d.d.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cholesterol Levels |
5.54; 5.96 | — |
| PRIMARY HDL-cholesterol Levels |
1.30; 1.47 | — |
| PRIMARY LDL-cholesterol Levels |
3.89; 4.02 | — |
| PRIMARY Determination of Composition of Intestinal Microbiota From Fecal Samples |
10.88; 8.89; 26.41; 30.38; 47.22; 52.99 | — |
| PRIMARY Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) |
10.10; 9.27; 53.16; 47.07; 76.50; 67.85 | — |
| PRIMARY Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) |
4.98; 5.16; 6.81; 7.86; 6.81; 7.26 | — |
| PRIMARY Systolic and Diastolic Blood Pressure |
135.56; 137.31; 82.11; 82.19 | — |
| PRIMARY Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples |
2.93; 2.08; 1.30; 1.52; 1.12; 1.61 | — |
| PRIMARY Triglyceride Levels |
1.72; 1.50 | — |
| SECONDARY Determination of Composition of Intestinal Microbiota From Fecal Samples |
10.88; 8.89; 26.41; 30.38; 47.22; 52.99 | — |
| SECONDARY Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples |
2.93; 2.08; 1.30; 1.52; 1.12; 1.61 | — |
| SECONDARY LDL-cholesterol Levels |
3.89; 4.02 | — |
| SECONDARY HDL-cholesterol Levels |
1.30; 1.47 | — |
| SECONDARY Triglyceride Levels |
1.72; 1.50 | — |
| SECONDARY Total Cholesterol Levels |
5.54; 5.96 | — |
| SECONDARY Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations) |
4.98; 5.16; 6.81; 7.86; 6.81; 7.26 | — |
| SECONDARY Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations) |
10.10; 9.27; 53.16; 47.07; 76.50; 67.85 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02041104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.