Beta-glucan and Insulin Sensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Polish Academy of Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Polish Academy of Sciences
ClinicalTrials.gov Identifier:
NCT01393210
First received: July 12, 2011
Last updated: July 27, 2011
Last verified: June 2011
  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. In Europe, obesity occurs in 10-20% males and 15-25% females. In Poland, obesity is present in about 20% of population.

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. It stimulates host defense against viral, bacterial and parasitical infections through binding with the specific receptors located on the immune system cells surface in many animal models. There are data that beta-glucan 1,3D-1,6D affects both innate and acquired immune response also in humans.

The aim of the study is the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie diet on the amount of visceral adipose tissue, 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 will consist 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 will give written informed consent, after receiving a full information about the aim and the design of the study by the research personnel.

At the beginning of the study, after subjects' qualification to the project and before the dietary intervention, the investigators will assess:

  • anthropometric measurements: BMI, waist-to-hip ratio (WHR), full physical examination will also be performed.
  • body composition with Maltron BioScan 920-2 equipment.
  • glucose tolerance with the oral glucose tolerance test.
  • insulin sensitivity with the euglycemic hyperinsulinemic clamp technique.
  • before and after the clamp, additional 6 ml of blood will be collected, and PBMC isolation will be performed.
  • before the clamp, a biopsy of subcutaneous adipose tissue will be performed.
  • isolation of mRNA from PBMC and adipose tissue will be performed. Then, the investigators will measure the expression of the selected genes with the Real Time PCR In adipose tissue, leptin and adiponectin expression will be measured.
  • additionally, serum concentrations of ghrelin, peptide Y-Y3-36, citruline and intestinal fatty acid-binding protein will be assessed.
  • in the stool, intestinal bacterial flora will be analyzed.

After the initial visit, participants will receive 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 will randomly be assigned to a group receiving or not beta-glucan preparation, as a addition to the low-calorie diet. Each group will consist of 20 subjects. Subjects assigned to a group receiving beta-glucan, will receive the preparation (BETA GLUKAN 1,3-1,6 Leiber GmbH 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.

Analysis of the compliance to the dietary indications and analysis of body composition will be performer every 2 weeks.

After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations performer at the beginning of the study will be repeated.


Condition Intervention
Obesity
Dietary Supplement: beta-glucan 1.3D-1.6D

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 ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low-calorie diet Dietary Supplement: beta-glucan 1.3D-1.6D
beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks
Active Comparator: low calorie diet plus beta-glucan Dietary Supplement: beta-glucan 1.3D-1.6D
beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
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

Contacts
Contact: Marek Straczkowski, MD, professor +48 85 8790659 m.straczkowski@pan.olsztyn.pl

Locations
Poland
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences Recruiting
Olsztyn, Poland, 10-747
Sponsors and Collaborators
Polish Academy of Sciences
  More Information

No publications provided

Responsible Party: Marek Straczkowski, MD, Professor, Polish Academy of Sciences, Institute of Animal Reproduction and Food Research
ClinicalTrials.gov Identifier: NCT01393210     History of Changes
Other Study ID Numbers: ZPChM-11-01
Study First Received: July 12, 2011
Last Updated: July 27, 2011
Health Authority: Poland: Ethics Committee

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

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014