Beta-glucan and Insulin Sensitivity in Obese Humans
|ClinicalTrials.gov Identifier: NCT01393210|
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : March 30, 2016
Obesity is an important health problem of modern civilization. In Western societies, almost half of the adult population has problems with an increased body weight. Products containing nutritional fiber has been used by humans for thousands of years. However, beta-glucan as biologically active compound, present in these products, has been identified relatively lately. This substance is a polymer of glucose and is present in two forms: 1,3D-1,6D and 1,3D-1,4D.
Water-insoluble beta-glucan (1,3D-1,6D) has immunomodulatory properties. The aim of the study was the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie diet on insulin sensitivity and the expression of selected proinflammatory cytokines in adipose tissue and peripheral blood mononuclear cells (PBMC) in obese humans with normal glucose tolerance.
The study group consisted of 40 subjects with marked overweight or obesity (body mass index, BMI > 28 kg/m2), without serious concomitant diseases not taking drugs affecting glucose or lipid metabolism, nonsmokers. Only volunteers, who gave written informed consent, after receiving a full information about the aim and the design of the study, were recruited.
At the beginning of the study, after subjects' qualification to the project and before the dietary intervention, the investigators performed:
- anthropometric measurements.
- oral glucose tolerance test.
- euglycemic hyperinsulinemic clamp.
- PBMC isolation before and after the clamp.
- biopsy of subcutaneous adipose tissue before the clamp.
- isolation of mRNA from PBMC and adipose tissue. Then, the expression of the selected genes with the Real Time PCR was measured.
- After the initial visit, participants received detailed instructions about low-calorie diet, with the aim of reduction of 5-7% of body weight and the examples of menu for 14 days.
Then, participants were randomly assigned to a group receiving or not beta-glucan preparation, as a addition to the low-calorie diet. Each group consisted of 20 subjects. Subjects assigned to a group receiving beta-glucan, received the preparation (BETA GLUCAN 1,3-1,6 Laboratoria Natury 500mg) together with the detailed instruction of its usage. This preparation is used as a non-prescription diet supplement, and the dose of 500 mg daily is indicated by the manufacturer.
After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations performed at the beginning of the study were repeated.
|Condition or disease||Intervention/treatment|
|Obesity||Dietary Supplement: low calorie diet plus beta-glucan Other: low-calorie diet|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Influence of Beta-glucan 1.3D-1.6D, Added to the Low-calorie Diet, on Insulin Sensitivity and the Expression of Selected Proinflammatory Cytokines in Adipose Tissue and Peripheral Blood Mononuclear Cells in Obese Humans|
|Study Start Date :||May 2011|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
Active Comparator: low-calorie diet
Intervention was low-calorie diet only for 12 weeks.
Other: low-calorie diet
low-calorie diet only for 12 weeks.
Active Comparator: low calorie diet plus beta-glucan
Intervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D 500 mg daily for 12 weeks.
Dietary Supplement: low calorie diet plus beta-glucan
beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeksOther: low-calorie diet
low-calorie diet only for 12 weeks.
- insulin sensitivity [ Time Frame: one year ]
- body weight [ Time Frame: one year ]
- amount of visceral adipose tissue [ Time Frame: one year ]
- expression of selected genes in PBMC and adipose tissue [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393210
|Institute of Animal Reproduction and Food Research, Polish Academy of Sciences|
|Olsztyn, Poland, 10-748|
|Principal Investigator:||Marek Straczkowski, MD, prof.||Institute of Animal Reproduction and Food Research, Polish Academy of Sciences|