Beta-glucan and Insulin Sensitivity in Obese Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marek Straczkowski, Polish Academy of Sciences
ClinicalTrials.gov Identifier:
NCT01393210
First received: July 12, 2011
Last updated: March 29, 2016
Last verified: March 2016
  Purpose

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 Intervention
Obesity
Dietary Supplement: low calorie diet plus beta-glucan
Other: low-calorie diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Polish Academy of Sciences:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight [ Time Frame: one year ] [ Designated as safety issue: No ]
  • amount of visceral adipose tissue [ Time Frame: one year ] [ Designated as safety issue: No ]
  • expression of selected genes in PBMC and adipose tissue [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: May 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393210

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

Responsible Party: Marek Straczkowski, Prof., Polish Academy of Sciences
ClinicalTrials.gov Identifier: NCT01393210     History of Changes
Other Study ID Numbers: ZPChM-11-01 
Study First Received: July 12, 2011
Last Updated: March 29, 2016
Health Authority: Poland: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Polish Academy of Sciences:
insulin sensitivity
adipose tissue
inflammation

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

ClinicalTrials.gov processed this record on July 28, 2016