RCT of a Polyherbal Dietary Supplement for Prediabetes
キーワード
概要
説明
Prediabetes is a common state in which blood glucose levels are elevated, but are not elevated high enough to be considered Type 2 Diabetes (T2D). The worldwide prevalence of prediabetes is high and rapidly increasing. People with prediabetes are at increased risk for developing a variety of chronic diseases. Most notably, prediabetes nearly always precedes diagnosis of T2D, a poorly-controlled disease adversely affecting 14% of adults in the United States. T2D is responsible for increased risk of heart disease, stroke, blindness and other vision problems, kidney disease, amputations and death. Prediabetes often progresses to T2D relatively quickly, as pancreatic beta-cell dysfunction perpetuates. There are currently limited pharmacological options available for safely reducing the burden of prediabetes. Furthermore, these pharmacological options often carry potentially deleterious side effects. Low-risk alternatives are needed where lifestyle modifications, such as increased physical activity and weight loss, have failed.
Herbal dietary supplements have shown promise in safely managing impaired glycemic control in prediabetic adults in many clinical studies. A wide variety of herbs have been previously studied for these purposes, including cinnamon, fenugreek, banaba, curcumin, and a variety of combination products. Of these, most have demonstrated improved management of glycemic control, particularly with regard to reducing fasting blood glucose and postprandial glucose, HbA1c, fasting insulin levels, HOMA-Insulin Resistance, and increasing HOMA-β cell function among prediabetic adult populations. Many herbs have also demonstrated benefit in the management of glycemic control in clinical trials among T2D populations. These herbs include berberine, ginseng, gymnema, banaba, cinnamon, fenugreek, and kudzu, all of which are present in GlucoSupreme™ Herbal.
The research team hypothesizes that GlucoSupreme™ Herbal will demonstrate superior improvements in markers of glycemic control than placebo over twelve weeks of daily supplementation among a sample of healthy adults. The research team aims to conduct a randomized, placebo-controlled, double-blinded clinical trial to evaluate this hypothesis among a diverse sample of 40 prediabetic adults, and will implement a 1:1 study allocation ratio. This study will utilize an adaptive sample size re-estimation (SSR) approach where participant enrollment may be extended beyond the originally planned sample size if interim effect size is smaller than anticipated, but still promising, thereby preserving study power; this will be determined by examination of available unblinded endpoint data by an independent statistician after 30 subjects are enrolled.
日付
| 最終確認済み: | 03/31/2020 |
| 最初に提出された: | 12/22/2017 |
| 提出された推定登録数: | 12/22/2017 |
| 最初の投稿: | 01/02/2018 |
| 最終更新が送信されました: | 04/05/2020 |
| 最終更新日: | 04/07/2020 |
| 実際の研究開始日: | 12/04/2017 |
| 一次完了予定日: | 09/29/2019 |
| 研究完了予定日: | 12/31/2019 |
状態または病気
介入/治療
Dietary Supplement: GlucoSupreme™ Herbal
Other: Control
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: GlucoSupreme™ Herbal Each daily serving of four GlucoSupreme™ Herbal tablets includes extracts from: cinnamon bark (Cinnamomum cassia) 500 mg, banaba leaf (Lagerstroemia speciosa standardized to 1% corosolic acid) 200 mg, kudzu root (Pueraria lobata standardized to 40% isoflavones) 200 mg, fenugreek seed (Trigonella foenum-graceum standardized to contain 60% saponins) 200 mg, and gymnema leaf (Gymnema sylvestre standardized to contain 25% gymnemic acid). Additionally, American ginseng root (Panax quinquefolius standardized to contain 5% ginsenosides) 200 mg, and berberine HCl derived from bark (Berberis aristata) 500 mg. Other ingredients include Cellulose (capsule), microcrystalline cellulose, silicon dioxide, and vegetable stearate. | Dietary Supplement: GlucoSupreme™ Herbal This study will assess changes in glycemic parameters and other biomarkers over a twelve week period, with two blood draws (Baseline and 12 weeks). Additionally, an IRB-approved research associate will call each study participant at the 6-week mid-point of the study to assess compliance and collect data on any adverse events. |
| Placebo Comparator: Control The placebo utilized in this clinical trial will be formulated by the manufacturer to be as similar as possible to the active intervention in appearance, odor, and other key characteristics. Packaging for the control will be identical to packaging for the Active Comparator. | Other: Control The placebo utilized in this clinical trial will be formulated by the manufacturer to be as similar as possible to the active intervention in appearance, odor, and other key characteristics. Packaging for the control will be identical to packaging for the Active Comparator. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Age ≥ 18 years 2. Prediabetic blood measurement (HbA1C) of 5.7-6.4% and/or fasting blood glucose of 100-125 mg/dl and/or 2-hour Oral Glucose Tolerance Test blood glucose value of 140 mg/dl-199 mg/dl1 2) taken within the last 12 weeks 3. Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements 4. Able to understand and write English 5. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects Exclusion Criteria: 1. Current daily use of any oral hypoglycemic medication or insulin injection 2. Current daily use of any supplement containing the herbs in the study supplement 3. Known allergies to any substance in the study supplement 4. Current daily tobacco smoker 5. Currently pregnant or planning to become pregnant in the next 12 weeks 6. Any current or previous diagnosis of diabetes (Type 1 or Type 2) 7. Myocardial infarction, vascular surgery, or stroke in the past year |
結果
主な結果の測定
1. Fasting Blood Glucose [Baseline and study end (12 weeks from baseline)]
2. Glycated hemoglobin/A1C (HbA1c) [Baseline and study end (12 weeks from baseline)]
3. Fasting insulin [Baseline and study end (12 weeks from baseline)]
4. Insulin Resistance (HOMA-IR) [Baseline and study end (12 weeks from baseline)]
5. β-cell function (HOMA-β) [Baseline and study end (12 weeks from baseline)]
6. Quantitative Insulin Sensitivity Check Index (QUICKI) [Baseline and study end (12 weeks from baseline)]
7. Fructosamine [Baseline and study end (12 weeks from baseline)]
8. GlycoMark [Baseline and study end (12 weeks from baseline)]
二次的な結果の測定
1. Lipid profile [Baseline and study end (12 weeks from baseline)]
2. Inflammation [Baseline and study end (12 weeks from baseline)]
3. Supplement compliance assessed using participant daily diary [Study end (12 weeks from baseline)]
4. Adverse events [Throughout the study and at study end (12 weeks from baseline)]
