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Beta-glucan and Insulin Sensitivity in Obese Humans

2016年3月29日 更新者:Marek Straczkowski

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.

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Olsztyn、ポーランド、10-748
        • Institute of Animal Reproduction and Food Research, Polish Academy of Sciences

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年~50年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:low-calorie diet
Intervention was low-calorie diet only for 12 weeks.
low-calorie diet only for 12 weeks.
アクティブコンパレータ:low calorie diet plus beta-glucan
Intervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D 500 mg daily for 12 weeks.
low-calorie diet only for 12 weeks.
beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
insulin sensitivity
時間枠:one year
one year

二次結果の測定

結果測定
時間枠
body weight
時間枠:one year
one year
amount of visceral adipose tissue
時間枠:one year
one year
expression of selected genes in PBMC and adipose tissue
時間枠:one year
one year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Marek Straczkowski, MD, prof.、Institute of Animal Reproduction and Food Research, Polish Academy of Sciences

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2011年5月1日

一次修了 (実際)

2015年8月1日

研究の完了 (実際)

2015年8月1日

試験登録日

最初に提出

2011年7月12日

QC基準を満たした最初の提出物

2011年7月12日

最初の投稿 (見積もり)

2011年7月13日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年3月30日

QC基準を満たした最後の更新が送信されました

2016年3月29日

最終確認日

2016年3月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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