Characterization of Red Dragon Fruit Peel Powder and Its Potential Role in Improving Vascular Function in Patients With Cardiometabolic Disorders
This study aims to characterize red dragon fruit (Selenicereus undatus) peel powder by evaluating its nutritional, physicochemical, and phytochemical properties. It will also explore its potential role in improving vascular function and cardiometabolic health among patients with cardiometabolic disorders.
調査の概要
状態
条件
詳細な説明
Cardiometabolic disorders including hypertension, dyslipidemia, and type 2 diabetes are strongly linked with vascular dysfunction, which increases the risk of cardiovascular morbidity and mortality. Conventional pharmacological therapies target metabolic abnormalities but often come with side effects, variable patient compliance, and limited improvement in vascular function. This has generated increasing interest in plant-derived nutraceuticals rich in bioactive compounds with antioxidant and endothelial-protective potential. Red Dragon Fruit (Selenicereus undatus (Haworth) D.R. Hunt) peel, usually considered an agro-waste, contains abundant betalains, flavonoids, dietary fiber, and essential minerals that may improve endothelial nitric oxide bioavailability, reduce oxidative stress, and modulate inflammatory pathways. This study aims to characterize the physicochemical and phytochemical profile of standardized dragon fruit peel powder and evaluate its potential role in improving vascular health in patients with cardiometabolic disorders. The intervention will involve daily supplementation with 4g, 6g and 8g of dragon fruit peel powder provided in a food-based vehicle along with DASH diet to three different groups over a period of 12 weeks. The study will enroll 90 adult participants aged 35-70 years diagnosed with at least one cardiometabolic disorder from CMH Hospital Lahore. Participants will be randomized into an intervention group receiving dragon fruit peel powder or a placebo group. Baseline and post-intervention assessments will include flow-mediated dilation (FMD), blood pressure, fasting glucose, HbA1c, lipid profile, inflammatory markers (hs-CRP, IL-6), and oxidative stress indicators (MDA, TAC). Statistical analysis will be performed using SPSS with significance set at p < 0.05. This study intends to establish Red Dragon Fruit peel as a safe, cost-effective, and sustainable dietary strategy for vascular health improvement and cardiometabolic risk reduction.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：sana noreen, PhD
- 電話番号：03018661160
- メール：sana.noreen@dnsc.uol.edu.pk
研究場所
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Punjab Province
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Lahore、Punjab Province、パキスタン、54000
- Sana Noreen
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コンタクト：
- sana noreen, PhD
- 電話番号：03018661160
- メール：sana.noreen@dnsc.uol.edu.pk
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Both genders (men and women), aged 35-70 years.
- Participants who provide informed consent.
- Participants with BMI ≥ 25.0 kg/m².
- Participants with diagnosed cardiometabolic disorder (type 2 diabetes, hypertension, or dyslipidemia).
- Participants with HbA1c between 6.5-9.0%.
- Participants with fasting plasma glucose 126-200 mg/dL.
- Participants with SBP 130-159 mmHg and/or DBP 80-99 mmHg.
- Participants with Total cholesterol > 200 mg/dL, LDL-C > 130 mg/dL, or HDL-C < 40 mg/dL (men) / < 50 mg/dL (women).
- Participants with Triglycerides > 150 mg/dL.
- Participants with hs-CRP > 3.0 mg/L.
- Participants with measurable IL-6 or MDA above reference range.
- Participants with reduced FMD or elevated PWV/Augmentation Index compared to age norms.
- Participants with liver enzymes (ALT, AST, ALP) ≤2.5× ULN and bilirubin <2× ULN.
- Participants with renal function eGFR ≥ 45 mL/min/1.73m².
- Participants with complete blood count within acceptable clinical range.
- Participants on stable medication doses for ≥8 weeks prior to enrollment.
- Participants willing to follow study diet and physical activity monitoring.
Exclusion Criteria:
- Participants with severe uncontrolled medical conditions such as advanced heart failure, end-stage renal disease, active malignancy, or chronic liver disease will be excluded.
- Individuals currently taking high-dose antioxidant supplements, herbal nutraceuticals, or experimental therapies that may interfere with study outcomes will not be included.
- Pregnant or breastfeeding women will be excluded to avoid potential risks and confounding effects.
- Participants with known allergies or hypersensitivity to dragon fruit or related plant products will not be enrolled.
- Individuals unable or unwilling to consume the Red Dragon Fruit peel powder or adhere to the DASH diet during the intervention period will be excluded.
- Participants with poor compliance history in previous clinical studies or those unable to commit to scheduled follow-ups will not be considered.
- Patients with recent major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months will be excluded.
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：PLACEBO T0
Participants will take a standard placebo shot of red dragon fruit accompanied by DASH diet and conventional treatment. |
Participants will take a standard placebo shot of red dragon fruit (Selenicereus undatus (Haworth) D.R. Hunt) accompanied by regular balanced diet and conventional treatment. |
|
実験的：Intervention Group (T₁)
Participants will take a placebo shot of red dragon fruit containing 4g of its peel powder accompanied by DASH diet along with conventional treatment |
Participants will take a placebo shot of red dragon fruit containing 4g of its peel powder accompanied by DASH diet along with conventional treatment. |
|
実験的：Intervention Group (T₂)
Participants will take a placebo shot of red dragon fruit containing 6g of its peel powder accompanied by DASH diet along with conventional treatment. |
Participants will take a placebo shot of red dragon fruit containing 6g of its peel powder accompanied by DASH diet along with conventional treatment |
|
実験的：Intervention Group (T3)
Participants will take a placebo shot of red dragon fruit containing 8g of its peel powder accompanied by DASH diet along with conventional treatment. |
Participants will take a placebo shot of red dragon fruit containing 8g of its peel powder accompanied by DASH diet along with conventional treatment |
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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Hypertension
時間枠：12 weeks
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Blood pressure will be measured in hypertensive patients using a calibrated digital sphygmomanometer and recorded in mmHg after standardized seated rest. |
12 weeks
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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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Lipid Profile
時間枠：12 weeks
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Lipid profile (total cholesterol, triglycerides, HDL-C, and LDL-C) will be assessed using an automated clinical chemistry analyzer, with results expressed in mg/dL |
12 weeks
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Liver Enzymes
時間枠：12 Weeks
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Liver enzymes (ALT, AST, and ALP) will be measured using an automated clinical chemistry analyzer, with results expressed in U/L. |
12 Weeks
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Fasting Blood glucose
時間枠：12 Weeks
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Fasting blood glucose will be measured using an automated clinical chemistry analyzer from venous blood samples collected after 8-12 hours of fasting, with results expressed in mg/dL. |
12 Weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
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
キーワード
その他の研究ID番号
- UOL/REB/26/22/03/0014
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?
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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