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Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss

2026年6月1日 更新者：An Pan、Huazhong University of Science and Technology

The Effect of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Medications for Weight Loss: a Randomized Double-blind Controlled Trial

The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10 grams per day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) medications for weight loss.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10 grams per day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) medications. Approximately 600 overweight or obese individuals using GLP-1 RA medications for weight loss will be enrolled. All participants will provide informed consent before randomization. Eligible individuals must be obese or be overweight with at least one body weight-related complications, and have been using GLP-1 RA medications at the time of enrollment for at least 3 months and plan to continue using them in the next 6 months. Eligible participants will be randomly assigned to inulin intervention or placebo group. Randomization will be computed within study center, age and sex groups. The intervention will last for 4 months. Questionnaire data and bio-samples will be collected before the start of intervention and at the end of the intervention. The primary outcomes are lipid levels measured in bio-samples. Data on secondary outcomes will be obtained through biomarker measurement and questionnaires.

研究の種類

介入

入学 (推定)

600

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。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
    • Hubei
      • Enshi、Hubei、中国
        • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
      • Shiyan、Hubei、中国
        • Sinopharm Dongfeng General Hospital
      • Wuhan、Hubei、中国
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan、Hubei、中国
        • Huazhong University of Science and Technology
        • コンタクト：
        • コンタクト：
      • Xiangyang、Hubei、中国
        • Xiangyang No.1 People's hospital

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

  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion criteria:

  • Be overweight or obese (meeting any of the following criteria):

    1. Obesity: BMI >=28 kg/m²;
    2. Overweight (BMI >= 24 kg/m²) with at least one body weight-related comorbidity: obstructive sleep apnea syndrome, prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia, polycystic ovary syndrome, or non-alcoholic fatty liver disease.
  • Must have received GLP-1 RA drugs (Semaglutide, Liraglutide, Benaglutide, Tirzepatide, or Mazdutide) for weight-loss intervention for at least 3 months, and plan to continue using them for the next six months.
  • Age 18-64 years.
  • Consent to participate and sign the informed consent form.

Exclusion criteria:

  • Currently using non-GLP-1 RA medications for weight-loss, or have undergone or plan to undergo weight-loss procedures within the next 4 months;
  • Long-term user of prebiotics or probiotics (excluding fermented dairy products such as yogurt);
  • Be allergic or intolerance to inulin-type substances;
  • Have participated in in other clinical trials within the past 3 months or are currently participating in other clinical trials;
  • Plan to be pregnant within the next year, are currently pregnant, or are breastfeeding;
  • Deemed unsuitable for participation by the investigator's judgment.

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：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
ダイエットサプリメント：inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
プラセボコンパレーター：maltodextrin
The intake dose is 10 grams per day for 4 months.
ダイエットサプリメント：Placebo Comparator: maltodextrin
The dose is 10 grams per day for 4 months.

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
メジャーの説明
時間枠
change in concentrations of blood lipid levels in millimole per liter (mmol/L).
時間枠：From enrollment to the end of intervention at 4 months
change in total cholesterol and triglycerides levels from baseline to 4-month visit. The values will be reported in mmol/L.
From enrollment to the end of intervention at 4 months

二次結果の測定

結果測定
メジャーの説明
時間枠
change in frequency of gastrointestinal symptoms
時間枠：From enrollment to the end of intervention at 4 months
change in frequency of gastrointestinal symptoms such as diarrhea and constipation baseline to 4-month visit
From enrollment to the end of intervention at 4 months
change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol)
時間枠：From enrollment to the end of intervention at 4 months
Description: change in concentration of glycosylated Hemoglobin A1c (HbA1c) from baseline to 4-month visit. The values will be reported in mmol/mol.
From enrollment to the end of intervention at 4 months
change in level of insulin resistance
時間枠：From enrollment to the end of intervention at 4 months
Change in HOMA-IR (homeostatic model assessment of insulin resistance) and adipo-IR (adipose tissue insulin resistance index) from baseline to 4-month visit. HOMA-IR will be calculated based on fasting glucose (mmol/L) and fasting insulin (mIU/L). Adipo-IR will be estimated using fasting insulin (mIU/L) and fasting free fatty acids (mmol/L).
From enrollment to the end of intervention at 4 months
change in body weight in kilograms (kg)
時間枠：From enrollment to the end of intervention at 4 months
Change in body weight (kg) from baseline to 4-month visit
From enrollment to the end of intervention at 4 months
change in body fat percentage (%)
時間枠：From enrollment to the end of intervention at 4 months
change in body fat percentage from baseline to 4-month visit. The values will be reported in percentage (%).
From enrollment to the end of intervention at 4 months
change in waist circumference in centimeters (cm)
時間枠：From enrollment to the end of intervention at 4 months
Change in waist Circumference (cm) from baseline to the 4-month visit.
From enrollment to the end of intervention at 4 months
change in level of gut microbiota abundance
時間枠：From enrollment to the end of intervention at 4 months
Change in gut microbiota abundance from baseline to 4-month visit
From enrollment to the end of intervention at 4 months
change in level of gut microbiota diversity
時間枠：From enrollment to the end of intervention at 4 months
Change in gut microbiota alpha and beta diversity from baseline to 4-month visit.
From enrollment to the end of intervention at 4 months
change in estimated glomerular filtration rate (eGFR) in milliliter per minute per 1.73 square meters (mL/min/1.73 m²)
時間枠：From enrollment to the end of intervention at 4 months
Change in estimated glomerular filtration rate (eGFR) from baseline to the 4-month visit. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI ) (2009) method will be used to estimate eGFR value. The value is reported in milliliter per minute per 1.73 square meters (mL/min/1.73 m²).
From enrollment to the end of intervention at 4 months
change in concentrations of liver function markers in units per liter (U/L)
時間枠：From enrollment to the end of intervention at 4 months
Change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) from baseline to the 4-month visit. These values are reported in units per liter (U/L).
From enrollment to the end of intervention at 4 months
change in level of C-reactive protein (CRP) in milligram per liter (mg/L)
時間枠：From enrollment to the end of intervention at 4 months
Change in C-reactive protein (CRP) from baseline to the 4-month visit. The value is reported in milligram per liter (mg/L).
From enrollment to the end of intervention at 4 months
change in blood pressure in millimeters of mercury (mmHg)
時間枠：From enrollment to the end of intervention at 4 months
Change in systolic and diastolic blood pressure from baseline to the 4-month visit. The values are reported in millimeters of mercury (mmHg).
From enrollment to the end of intervention at 4 months

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

Huazhong University of Science and Technology

捜査官

  • 主任研究者：An Pan、Huazhong University of Science and Technology

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 (推定)

2026年6月1日

一次修了 (推定)

2026年11月1日

研究の完了 (推定)

2026年11月1日

試験登録日

最初に提出

2026年5月21日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Prebiotics in GLP-1 RA users

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

IPD プランの説明

To protect the privacy of participants, the investigators decide not to share individual data.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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