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治験 NCT07089732（対象：肥満、前糖尿病）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals 100 食事療法
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07089732 は 介入研究 臨床試験 で、肥満、前糖尿病 に関するものです。現在は 募集準備中 で、2025年8月8日 に開始予定です。100 名の参加者 の募集が計画されています。この試験は Chung Shan Medical University によって主導され、2026年6月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年7月28日 です。
概要
A clinical human dietary intervention trial was conducted to investigate the effects of GLP-1 FORMUL liquid supplementation in individuals with prediabetes or obesity, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.
詳細説明
This 12-week randomized, placebo-controlled clinical trial aims to evaluate the nutritional and metabolic effects of GLP-1 FORMULA liquid supplementation. A total of 100 adult participants will be recruited and randomly assigned to one of two groups: (1) placebo group (n = 50), and (2) GLP-1 FORMULA group (n = 50). Participants will consume one bottle (50 g) of either GLP-1 FORMULA or placebo 30 minutes prior to thei...もっと見る
公式タイトル
Evaluation of the Effects of GLP-1 Formula Liquid Drink on Gut Microbiota Modulation and Blood Glucose Regulation in Prediabetic Populations
疾患名
肥満前糖尿病その他の研究識別子
- CS2-24199
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的GLP-1 formula liquid drink GLP-1 formula liquid drink, 50 g/glass jar | GLP-1 formula liquid drink One glass jar (50 g) of the GLP-1 formula liquid drink was administered once daily, 30 minutes prior to the first meal of the day. |
プラセボ対照薬placebo The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component. | プラセボ One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change from baseline in BMI at weeks 8 and 12 | Assessment of changes in BMI at baseline, week 8, and week 12 | Week 0, 8 and 12 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change from baseline in blood glucose at weeks 8 and 12 | Assessment of blood glucose changes at weeks 0, 8, and 12 | Week 0, 8 and 12 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Adults aged 18 to 70 years.
- Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.
- Have not participated in similar clinical studies within the past three months.
- Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.
- Diagnosed with autoimmune diseases or cancer.
- Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.
- History of gastrointestinal surgery.
- Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.
- Known allergy or hypersensitivity to probiotics or any of the study product ingredients.
- History of major psychiatric disorders.
- History of substance abuse or alcohol dependency.
Chung Shan Medical University試験中央連絡先
連絡先: Chin-Lin Hsu Professor, 04-24730022 Ext. 12222, [email protected]
1 1カ国の場所
South
Chung Shan Medical University, Taichung, South, 402 Recruiting, Taiwan
Chin-Lin Hsu Professor, 連絡先, 04-24730022 Ext. 12222, [email protected]