Beta-glucan and Insulin Sensitivity in Obese Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393210
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
Marek Straczkowski, Polish Academy of Sciences

Brief Summary:

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 Phase
Obesity Dietary Supplement: low calorie diet plus beta-glucan Other: low-calorie diet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Insulin

Arm Intervention/treatment
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 weeks

Other: low-calorie diet
low-calorie diet only for 12 weeks.

Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: one year ]

Secondary Outcome Measures :
  1. body weight [ Time Frame: one year ]
  2. amount of visceral adipose tissue [ Time Frame: one year ]
  3. expression of selected genes in PBMC and adipose tissue [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • marked overweight or obesity (BMI above 28 kg/m2)
  • normal glucose tolerance

Exclusion Criteria:

  • morbid obesity (BMI above 40 kg/m2)
  • impaired glucose tolerance or diabetes
  • cardiovascular diseases
  • other serious disease
  • smoking
  • usage of drugs known to affect carbohydrate or lipid metabolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01393210

Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
Olsztyn, Poland, 10-748
Sponsors and Collaborators
Marek Straczkowski
Principal Investigator: Marek Straczkowski, MD, prof. Institute of Animal Reproduction and Food Research, Polish Academy of Sciences

Responsible Party: Marek Straczkowski, Prof., Polish Academy of Sciences Identifier: NCT01393210     History of Changes
Other Study ID Numbers: ZPChM-11-01
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marek Straczkowski, Polish Academy of Sciences:
insulin sensitivity
adipose tissue

Additional relevant MeSH terms:
Insulin Resistance
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs