ObesityNCT01393210
Beta-glucan and Insulin Sensitivity in Obese Humans
A study testing low calorie diet plus beta-glucan and low-calorie diet in people with Obesity, run by Marek Straczkowski at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- low calorie diet plus beta-glucan and low-calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- May 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- marked overweight or obesity (BMI above 28 kg/m2)
- normal glucose tolerance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
Olsztyn, 10-748
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- low calorie diet plus beta-glucan, low-calorie diet
- Keywords
- insulin sensitivity, adipose tissue, inflammation
- Medical subject headings
- Obesity, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low calorie diet plus beta-glucanDietary supplement
beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks
low-calorie dietOther
low-calorie diet only for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| low-calorie diet | Active comparator | Intervention was low-calorie diet only for 12 weeks. Receives: Other: low-calorie diet |
| low calorie diet plus beta-glucan | Active comparator | Intervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D 500 mg daily for 12 weeks. Receives: Dietary Supplement: low calorie diet plus beta-glucan; Other: low-calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
Measured: one year
Secondary outcomes (3)
body weight
Measured: one year
amount of visceral adipose tissue
Measured: one year
expression of selected genes in PBMC and adipose tissue
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marek Straczkowski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marek Straczkowski, Polish Academy of Sciences
- Investigators
- Marek Straczkowski, MD, prof., Principal investigator, Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393210
- Sponsor's protocol ID
- ZPChM-11-01
- Status last verified
- Mar 2016
- First submitted
- 12 Jul 2011
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Danowska M, Stefanowicz M, Straczkowski M. The expression of NFAT family genes in subcutaneous adipose tissue before and after weight loss in obese individuals. Nutr Metab Cardiovasc Dis. 2024 Nov;34(11):2455-2463. doi: 10.1016/j.numecd.2024.06.011. Epub 2024 Jun 20.
PubMed 39069466Nikolajuk A, Stefanowicz M, Straczkowski M, Karczewska-Kupczewska M. Changes in Adipose Tissue Gene Expression of the Core Components of the Hippo Signaling Pathway in Young Adults with Uncomplicated Overweight or Obesity Following Weight Loss. J Nutr. 2023 Mar;153(3):665-672. doi: 10.1016/j.tjnut.2023.01.024. Epub 2023 Jan 26.
PubMed 36805181
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01393210
- Acronym / sponsor ID
- ZPChM-11-01
- Conditions
- Obesity
- Keywords
- insulin sensitivity, adipose tissue, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marek StraczkowskiUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-calorie diet | Active comparator | Other: low-calorie dietIntervention was low-calorie diet only for 12 weeks. |
| low calorie diet plus beta-glucan | Active comparator | Dietary Supplement: low calorie diet plus beta-glucan, Other: low-calorie dietIntervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D 500 mg daily for 12 weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- marked overweight or obesity (BMI above 28 kg/m2)
- normal glucose tolerance
Key exclusion criteria (6 listed)
- morbid obesity (BMI above 40 kg/m2)
- impaired glucose tolerance or diabetes
- cardiovascular diseases
- other serious disease
- smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low calorie diet plus beta-glucanbeta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks | Dietary supplement | low calorie diet plus beta-glucan |
| low-calorie dietlow-calorie diet only for 12 weeks. | Other | low calorie diet plus beta-glucan, low-calorie diet |
Primary outcome
insulin sensitivity
Time frame: one year
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Derived from this study: PubMed 39069466Danowska M, Stefanowicz M, Straczkowski M. The expression of NFAT family genes in subcutaneous adipose tissue before and after weight loss in obese individuals. Nutr Metab Cardiovasc Dis. 2024 Nov;34(11):2455-2463. doi: 10.1016/j.numecd.2024.06.011. Epub 2024 Jun 20.
- Derived from this study: PubMed 36805181Nikolajuk A, Stefanowicz M, Straczkowski M, Karczewska-Kupczewska M. Changes in Adipose Tissue Gene Expression of the Core Components of the Hippo Signaling Pathway in Young Adults with Uncomplicated Overweight or Obesity Following Weight Loss. J Nutr. 2023 Mar;153(3):665-672. doi: 10.1016/j.tjnut.2023.01.024. Epub 2023 Jan 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Straczkowski, MD, prof. principal investigator
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low calorie diet plus beta-glucan and low-calorie diet in people with Obesity, run by Marek Straczkowski at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin sensitivity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393210, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.