Human Absorption Study of Liposomal Glucosamine Supplements
Effect of Double Nutri® Liposomal Encapsulation Technology on Human Absorption of Glucosamine Supplements
The objective of this study is to evaluate the effects of liposomal encapsulation using different ratios of gum arabic and lecithin on the bioavailability of a liquid glucosamine supplement in humans.
研究概览
地位
详细说明
This study is a single-center, self-controlled crossover human trial designed to evaluate the differences in blood concentration changes and bioavailability following a single oral dose of glucosamine supplements.
Healthy adult participants aged 18 years and older will be enrolled. Each participant will complete four study sessions, with a minimum washout period of 7 days between sessions. On each study day, venous blood samples will be collected prior to test product administration (0 minutes) to assess glucosamine levels, complete blood count, blood lipids, blood glucose, and liver and kidney function indicators.
After baseline blood collection, a standardized breakfast will be provided and consumed within 10 minutes, followed by administration of the test product. Venous blood samples will then be collected at 0.5, 1, 2, 4, 8, and 24 hours post-intake to measure glucosamine concentrations. Lunch will be provided after the 4-hour blood draw, and dinner will be provided after the 8-hour blood draw. Identical meals will be provided on four study sessions.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Tong-Lin Wu
- 电话号码:+886 02-87977811
- 邮箱:Tony.Wu@tci-bio.com
研究联系人备份
- 姓名:Ping Lin
- 电话号码:+886 02-87977811
- 邮箱:candice.lin@tci-bio.com
学习地点
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-
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Taipei、台湾、114
- 招聘中
- TCI Co., Ltd
-
接触:
- Ping Lin
- 电话号码:+886 02-8797-7811
- 邮箱:candice.lin@tci-bio.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged ≥18 years, regardless of sex, who are willing to sign the informed consent form and are able to fully comply with all study procedures.
Exclusion Criteria:
- Pregnant or breastfeeding women, or individuals who are unwilling to use a physical method of contraception during the study period, such as condoms or an intrauterine device.
- Employees of TCI Co., Ltd. and their family members.
- Individuals who have regularly taken any supplements or medications containing glucosamine or N-acetylglucosamine (N-acetyl-glucosamine) within 14 days prior to study initiation, defined as use for ≥7 consecutive days.
- Individuals with a history of chronic gastrointestinal disorders, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), chronic diarrhea, Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, or ulcerative colitis; a history of epilepsy or seizures; liver or kidney disease; malignancy; endocrine disorders; psychiatric disorders; alcohol or substance abuse; or other significant organic diseases, as determined based on medical history.
- Individuals with a history of gastrointestinal surgery, organ transplantation, or other major surgery.
- Individuals who have experienced acute gastroenteritis within 2 weeks prior to study initiation.
- Individuals with a history of allergy to any ingredient in the investigational products. The investigational products contain shrimp- and soy-derived ingredients.
- Vegetarians, as the glucosamine used in this study is derived from shrimp.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:High-Emulsified Liposomal Glucosamine Liquid
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine. |
The formulation primarily consists of glucosamine HCl, a high proportion of soy lecithin, and gum arabic, and is processed using the patented Double Nutri Liposomal technology.
其他名称:
|
|
实验性的:Low-Emulsified Liposomal Glucosamine Liquid
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine. |
The formulation primarily consists of glucosamine HCl, a low proportion of soy lecithin, and gum arabic, and is processed using the patented Double Nutri Liposomal technology.
其他名称:
|
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有源比较器:Glucosamine Liquid without Liposomal
One sachet will be administered per dose, with each sachet containing 1,500 mg of glucosamine. |
The formulation primarily consists of glucosamine HCl and is not processed using the patented Double Nutri Liposomal technology. |
|
有源比较器:Glucosamine tablet without Liposomal
Three tablets will be administered per dose, with each tablet containing 500 mg of glucosamine. |
The tablet formulation primarily consists of glucosamine HCl and is not processed using liposomal technology. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Plasma glucosamine level (ng/mL)
大体时间:at 24 hours after taking test sample
|
Plasma glucosamine levels will be measured at fasting and at 0.5, 1, 2, 4, 8, and 24 hours post-intake. |
at 24 hours after taking test sample
|
合作者和调查者
调查人员
- 首席研究员:Tong-Lin Wu、TCI Co., Ltd.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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