CTRI/2026/02/103219尚未招募不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Dose-Related Effects of White Kidney Bean (Phaseolus vulgaris) Extract - Phaseolean® on Fasting and Post-Prandial Serum GLP-1 (Glucagon Like Peptide 1) Levels in Pre-diabetic Adults.
Ambe Phytoextracts Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
This is an exploratory, interventional, randomized, double-blind, placebo-controlled, parallel group, three arm, comparative pilot study to determine the dose-related effects of White Kidney Bean (Phaseolus vulgaris) extract - Phaseolean®on fasting and post-prandial serum GLP-1 (Glucagon Like Peptide 1) levels in pre-diabetic adults.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
The study will be conducted over a duration of 30 days and will include 3 visits including screening visit. All eligible participants will undergo laboratory evaluation (blood tests). Safety will be assessed throughout the study by monitoring adverse events. Additionally, vital signs will be monitored and changes, if any, in the laboratory parameters (CBC, LFT, RFT, Lipid parameters and glucose) will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males and non-lactating/non-pregnant female participants between ages of 18 to 55 years (both inclusive at the time of consent).
- •Participants with BMI between 25–32 kg/m² (Overweight to Class I Obese).
- •Prediabetic participants with HbA1c between 5.7–6.4%.
- •Participants having good general health as determined by the Investigator on the basis of medical history and physical examination.
- •Participants of childbearing potential: o must have a negative urine pregnancy test performed during screening.
- •o willing to follow all the acceptable forms of contraception as applicable.
- •Participants willing to consume test products throughout the study period as instructed.
- •Participants who are not planning to relocate or planning to take vacation for more than 2 to 3 days.
- •Participants who are willing to maintain a consistent diet and lifestyle routine throughout the study.
- •Participants who are willing to voluntarily participate in the study and provide signed informed consent.
- •Participants should be willing and able to follow the study protocol to participate in the study.
排除标准
- •Participants with known allergy to the legumes, extract or related herbal extracts.
- •Participants with known allergy or hypersensitivity to any ingredients of the test products.
- •Participants who are planning pregnancy during the study period.
- •Participants who are diagnosed with diabetes mellitus (FBG more than or equal to 126 mg/dL or HbA1c more than or equal to 6.5%).
- •Participants who are using antidiabetic, lipid-lowering, or weight-loss medications in the past 2 months.
- •Participants who have a history or are diagnosed gastrointestinal disease that may affect digestion or gut hormone secretion.
- •Participants using medications or supplements known to affect gut hormones.
- •Participants who have tested positive for HIV test.
- •Participants having any chronic illness or health condition such as hyperthyroidism or hypothyroidism, diabetes, Peripheral Artery Disease, CKD, previous major surgery, hepatitis etc.
- •that can interfere with the outcome of the study.
- •Participants undergone any surgical procedure undergone within the past 12 weeks.
- •Participants with a history or presence of significant alcoholism or drug abuse and smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products.
研究者
Dr Divya Mori
Cliantha Research
研究点 (1)
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