Effect of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus (INULIN-DM2)
Effects of Eight Weeks of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Trial
調査の概要
状態
詳細な説明
This randomized, double-blind, placebo-controlled, parallel-group clinical trial will evaluate the effects of agave inulin supplementation on metabolic profile and intestinal abundance of Bifidobacterium and Lactobacillaceae in adults with type 2 diabetes mellitus (T2DM).
Participants will be randomly assigned to receive either agave inulin (10 g/day) or placebo for eight weeks. The intervention will be administered as two daily doses of 5 g consumed before breakfast and before dinner.
Metabolic assessments will be performed at baseline and week 8 and will include fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), insulin resistance (HOMA-IR), total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides. Anthropometric and body composition measurements, including body weight, body mass index (BMI), waist circumference, body fat percentage, and muscle mass percentage, will also be evaluated.
Fecal samples will be collected at baseline and week 8, preserved in DNA/RNA Shield solution, and stored at -80°C until analysis. Microbial DNA will be extracted using the ZymoBIOMICS™ DNA Miniprep Kit. Gut microbiota characterization will be performed through 16S rRNA gene sequencing of the V4 hypervariable region using primers 515F and 806R on the Illumina MiSeq platform. Bioinformatic analyses will be conducted using the QIIME pipeline to determine the abundance of Bifidobacterium and Lactobacillaceae. Statistical analyses will be performed according to the intention-to-treat principle.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Querétaro
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Querétaro City、Querétaro、メキシコ、76230
- Facultad de Ciencias Naturales, Campus Juriquilla
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Confirmed diagnosis of type 2 diabetes mellitus.
- Age between 20 and 75 years.
- Residence in Querétaro, Mexico.
- Stable oral hypoglycemic treatment and/or basal insulin.
- Ability to provide informed consent.
Exclusion Criteria:
- HbA1c > 9.5%.
- Current use of probiotics, prebiotics, synbiotics, or fiber supplements within the previous 3 months.
- Use of alpha-glucosidase inhibitors.
- Severe cardiovascular disease.
- Chronic kidney disease stage 3b or higher.
- Active gastrointestinal disease.
- Pregnancy or lactation.
- Known allergy to agave or fructans.
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Maltodextrin Placebo
Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
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Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
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実験的：Agave Inulin
Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
|
Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in glycated hemoglobin (HbA1c)
時間枠：Baseline and Week 8.
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Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.
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Baseline and Week 8.
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Change in insulin resistance (HOMA-IR
時間枠：Baseline and Week 8.
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Insulin resistance estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as [fasting glucose (mg/dL) × fasting insulin (μU/mL)]/405.
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Baseline and Week 8.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in fasting plasma glucose
時間枠：Baseline and Week 8.
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Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast.
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Baseline and Week 8.
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Change in fasting insulin
時間枠：Baseline and Week 8.
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Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast.
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Baseline and Week 8.
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Change in total cholesterol
時間枠：Baseline and Week 8.
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Serum total cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in LDL-cholesterol
時間枠：Baseline and Week 8.
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Serum low-density lipoprotein cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in HDL-cholesterol
時間枠：Baseline and Week 8.
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Serum high-density lipoprotein cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in triglycerides
時間枠：Baseline and Week 8.
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Serum triglyceride concentration (mg/dL).
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Baseline and Week 8.
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Change in intestinal abundance of Bifidobacterium
時間枠：Baseline and Week 8.
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Relative abundance of Bifidobacterium determined from fecal samples using 16S rRNA gene sequencing.
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Baseline and Week 8.
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Change in intestinal abundance of Lactobacillaceae
時間枠：Baseline and Week 8.
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Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing.
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Baseline and Week 8.
|
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Change in body weight
時間枠：Baseline and Week 8.
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Body weight measured in kilograms using standardized procedures.
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Baseline and Week 8.
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Change in body mass index (BMI)
時間枠：Baseline and Week 8.
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Body mass index calculated as weight (kg)/height (m²).
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Baseline and Week 8.
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Change in waist circumference
時間枠：Baseline and Week 8.
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Waist circumference measured in centimeters using a non-elastic measuring tape.
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Baseline and Week 8.
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Change in body fat percentage
時間枠：Baseline and Week 8.
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Body fat percentage assessed by bioelectrical impedance analysis.
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Baseline and Week 8.
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Change in muscle mass percentage
時間枠：Baseline and Week 8.
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Muscle mass percentage assessed by bioelectrical impedance analysis.
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Baseline and Week 8.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 011FCN2024
- UNIVERSİTY (その他の識別子：KAHRAMANMARAŞ SÜTÇÜ İMAM UNİVERSİTY)
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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