Beta-glucan and Insulin Sensitivity in Obese Humans
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
low calorie diet plus beta-glucan
low-calorie diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring insulin sensitivity, adipose tissue, inflammation
Eligibility 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
Sites / Locations
- Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
low-calorie diet
low calorie diet plus beta-glucan
Arm Description
Intervention was low-calorie diet only for 12 weeks.
Intervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D 500 mg daily for 12 weeks.
Outcomes
Primary Outcome Measures
insulin sensitivity
Secondary Outcome Measures
body weight
amount of visceral adipose tissue
expression of selected genes in PBMC and adipose tissue
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01393210
Brief Title
Beta-glucan and Insulin Sensitivity in Obese Humans
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marek Straczkowski
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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 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 by the research personnel were recruited.
At the beginning of the study, after subjects' qualification to the project and before the dietary intervention, the investigators assessed:
anthropometric measurements: BMI, waist-to-hip ratio (WHR), full physical examination.
body composition with Tanita TBF-511 Body Fat Analyzer.
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 was collected, and PBMC isolation was performed.
before the clamp, a biopsy of subcutaneous adipose tissue was performed.
isolation of mRNA from PBMC and adipose tissue was performed. Then, the expression of the selected genes with the Real Time PCR In adipose tissue was measured measured.
additionally, serum concentrations of ghrelin, peptide Y-Y3-36, citruline and intestinal fatty acid-binding protein was assessed.
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.
Analysis of the compliance to the dietary indications and analysis of body composition was performed every 2 weeks.
After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations performed at the beginning of the study were repeated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
insulin sensitivity, adipose tissue, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low-calorie diet
Arm Type
Active Comparator
Arm Description
Intervention was low-calorie diet only for 12 weeks.
Arm Title
low calorie diet plus beta-glucan
Arm Type
Active Comparator
Arm Description
Intervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D 500 mg daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
low calorie diet plus beta-glucan
Intervention Description
beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
low-calorie diet
Intervention Description
low-calorie diet only for 12 weeks.
Primary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
one year
Secondary Outcome Measure Information:
Title
body weight
Time Frame
one year
Title
amount of visceral adipose tissue
Time Frame
one year
Title
expression of selected genes in PBMC and adipose tissue
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Straczkowski, MD, prof.
Organizational Affiliation
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
City
Olsztyn
ZIP/Postal Code
10-748
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Beta-glucan and Insulin Sensitivity in Obese Humans
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