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慢性感冒和营养药物增强了棕色脂肪的激活和褐变效率,以促进棕色脂肪组织介导的抗代谢综合征作用(BEACON BEAMS 研究)

2026年11月5日 更新者:Melvin Leow、Institute for Human Development and Potential (IHDP), Singapore

Our body fat (adipose tissue) is largely made up of white adipose tissue (WAT) that stores surplus energy as white fat depots. In addition, adult humans have another type of fat similar to the brown fat in babies that burns up fat to generate heat for maintenance of body temperature during cold exposure. Adults have much lesser amounts of such brown adipose tissue (BAT), most of which are located within the sides of the neck and under the skin above the collar bones as well as along the sides of the spine. BAT consists of both classical brown fat identical to that found in babies as well as beige fat (composed of brown-in-white or 'brite' fat cells) found mainly in adults. Both types of BAT burn fat upon activation by various stimuli such as cold or by substances like curcumin found in turmeric ginger rhizome root.

This study is carried out to find out the effects of cold stimulation and/or a known BAT-activating nutraceutical among those overweight/obese people suffering from metabolic syndrome.

研究概览

地位

主动,不招人

条件

干预/治疗

详细说明

This study will recruit 60 participants that are overweight/obese people suffering from metabolic syndrome. The participants will be asked to come to the Clinical Nutrition Research Centre (CNRC) for a screening session (1st visit) and given plenty of time to read this information sheet and the opportunity to ask questions. Once the participants are fully informed regarding the study and all their questions have been satisfactorily answered, the participants will be given a consent form to complete and sign in the presence of the researcher. Following this, in order to gauge their suitability for taking part in the study, an assessment will be carried out. This assessment needs to be carried out in a fasted state and participants would therefore have to come one morning following an overnight fast. The screening will include anthropometric measurements, blood pressure measurement and blood sampling. Anthropometric measurements taken will be height, weight, waist circumference and hip circumference. Body composition will be measured using an electrical impedance analyser (BIA). Blood pressure will be measured using an automatic blood pressure monitor. The participants will also undergo a blood sampling from their vein (6 mL or approximately 1.5 teaspoons) to be tested for thyroid function, glucose and lipid profile. Pre-menopausal females will also undergo a urine pregnancy test to exclude pregnancy prior to participation at study entry. The participants who have been accepted into the study will be randomly assigned to one of the 3 parallel intervention groups below (20 subjects per group) via an online randomizer (www.randomizer.org). Randomization means assigning them to one of the three groups by chance, like tossing a coin or rolling a dice. The 3 parallel intervention groups (Week 0 to 12) are Group 1 (CS): Cold stimulation using cooling vest x 60 min once daily over 3 months, Group 2 (BN): Browning nutraceutical (2000mg curcumin) to be taken once daily over 3 months, Group 3 (CSBN): Cold stimulation using cooling vest x 60 min once daily and Browning nutraceutical (2000mg curcumin) to be taken once daily over 3 months. The participants will then be expected to come to the centre for a total of six separate test sessions, over a span of 6 months (2 test sessions each at week 0, 12 and 24 approximately +/-2 weeks). For each of the six test sessions,the participants will be required to fast overnight and avoid caffeine and alcohol for 8-10 hours, only plain water can be consumed during the fast before reporting at the CNRC in the morning between 8 to 9 am. The participants are to avoid any physical activity/exercise and alcohol on the day prior to the visit. The test sessions will be as follows: On the 2nd visit (first test session) at week 0, the participants will need come to CNRC in the morning and a fasting blood sample (40 mL or approximately 8 teaspoons) and urine sample will be collected before they undergo metabolic rate measurement with IRT focusing on their neck and area above the collar bone in a whole body room calorimeter for the next 45 minutes. The participants will then undergo a mild cold stimulation of about 14 degree Celsius by wearing a cooling vest for the next 45 minutes, in which metabolic rate measurement and IRT in the whole body calorimeter will be performed during this period. Please note that wearing the cooling vest may lead to some shivering, but it is generally considered safe. Upon exiting the whole body calorimeter, the participants will remove the cooling vest and then proceed to Clinical Imaging Research Centre (CIRC) located at the basement level of the same building, where an intravenous indwelling cannula will be inserted into an arm vein and 20 mL (approximately 4 teaspoons) of blood and another urine sample will be collected again. The participants will then wear the cooling vest again for approximately another 60 min and in between they will receive an intravenous injection of a radioactive labeled glucose called 18-FDG through the intravenous cannula. The cooling vest will be removed just prior to the start of the PET (Positron Emission Tomography) and MRI/MRS (Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy) that will take place over the next 1 hour to quantify BAT (Brown Adipose Tissue) and abdominal white fat including liver and muscle fat. The participants will also need to undergo a body composition evaluation using dual energy X-ray absorptiometry (DXA) (approximately 20 mins duration) which allows quantification of fat, lean and bone mass. However, the participants will be given the option to do the DXA scan on their next/3rd visit according to their preference. After which, the participants will be free to leave. On the 3rd visit (second test session) at week 0, the participants will need come to CNRC in the morning for an Oral Glucose Tolerance Test (OGTT). Anthropometric measurements taken will be height, weight, waist circumference and hip circumference. Body composition will be measured using an electrical impedance analyser (BIA). Blood pressure will be measured using an automatic blood pressure monitor. A fasting blood sample (4 mL or less than 1 teaspoon) will be collected and participants will then be required to consume a glucose drink (75g of glucose) within 5 minutes. Subsequently after 120 min, another blood sample (4 mL or less than 1 teaspoon) will be collected. During the entire test session, the participants will have to stay rested and in the laboratory. Television and a workspace will be provided for the participants use if required. At the end of 2 hours of testing, for participants who have not undergone for the DXA scan on the 2nd visit, they will then proceed to complete the DXA scan (approximately 20 mins duration). After which, participants will be free to leave.The above 2 test sessions may be scheduled in any order,but to be completed no more than 2 weeks apart. The participants will now start the study intervention procedures as per the intervention group randomly assigned to them for the next 12 weeks or 3 months. Participants who are assigned to group 1 / cold stimulation (CS), will be expected to undergo a mild cold stimulation of about 14 degree Celsius by wearing a cooling vest for approximately an hour daily for the next 12 weeks or 3 months. Participants who are assigned to group 2 / browning nutraceutical (BN), will be expected to consume 2000mg of curcumin (in forms of capsules) daily for the next 12 weeks or 3 months. Curcumin is a naturally-occurring polyphenol antioxidant that is found in turmeric ginger rhizome root and has been widely known in Asia to have health benefits. Since both substances are commonly consumed among Asians, it is relevant to study their combined chronic clinical effects on BAT. Use of curcumin to stimulate BAT is essentially safe as both are naturally occurring plant derived substances from Curcuma longa rhizome. It is generally recognised as safe for human consumption. The US FDA has approved curcumin as 'Generally Recognised as Safe' (GRAS) status and allows these to be taken as foods ingredients. Participants who are assigned to group 3 / cold stimulation and browning nutraceutical (CSBN), will be expected to undergo a mild cold stimulation of about 14 degree Celsius by wearing a cooling vest for approximately an hour and, consume 2000mg of curcumin (in forms of capsules) daily for the next 12 weeks or 3 months. The participants will then be required to come for the 4th visit (third test session) and 5th visit (fourth test session) at week 12 (after completing the 3 months of intervention), as per follows:

On the 4th visit (third test session) at week 12, participants will repeat the same procedures as per that of the 2nd visit (first test session). For the 5th visit (fourth test session) at week 12, participants will need to come to CNRC in the morning in a fasted state and proceed first to CIRC for a 30 min MRI/ MRS only scan of BAT/WAT to study the fat composition. Subsequent procedures will be same as that of the 3rd visit (second test session). After which, there will be no more intervention and participants will continue with their usual lifestyle and diet for the next 3 months (week 12 to 24).The participants will lastly be required to come for the 6th visit (fifth test session) and 7th visit (sixth test session) at week 24 (6 months from start of study), and repeat the same procedures as per that of the 2nd visit (first test session) and the 3rd visit (second test session) respectively. Notes: *The 2 test sessions each at week 0, 12 and 24 may be scheduled within 4 weeks from each time point. *The following test sessions will be scheduled no more than 4 weeks apart: o First and second test sessions for Week 0 (in any order) o Third and fourth test sessions for Week 12 (in any order) o Fifth and sixth test sessions for Week 24 (in any order)

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、117609
        • Singapore Institute of Clinical Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 50年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or Female

  • Chinese, Malay or Indian ethnicity

  • Age between 21 to 50 years

  • Able to give informed consent

  • Body mass index (BMI) between 23 to 32 kg/m2

  • Thyroid function test must be within the normal ranges

  • Willing to avail yourself for the whole study and follow study procedures

  • EITHER deemed to have pre-metabolic syndrome when waist circumference is > 90 cm in men or > 80 cm in women, with none or up to one of the following condition:

    • Triglyceride level ≥ 1.7 mmol/L
    • HDL cholesterol ≤ 1.0 mmol/L in men, and ≤ 1.3 mmol/L in women
    • Blood pressure ≥ 130/85 mmHg
    • Fasting blood glucose of ≥ 6.1 mmol/L
  • OR deemed to have metabolic syndrome when three or more of the following conditions are present:

    • Waist circumference > 90 cm in men and > 80 cm in women
    • Triglyceride level ≥ 1.7 mmol/L
    • HDL cholesterol ≤ 1.0 mmol/L in men, and ≤ 1.3 mmol/L in women
    • Blood pressure ≥ 130/85 mmHg
    • Fasting blood glucose of ≥ 6.1 mmol/L

Exclusion Criteria:

  • Are pregnant or contemplating pregnancy (for female subjects)
  • Partake in sports at the competitive and/or endurance levels
  • Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Have major chronic disease such as heart disease or cancer
  • Take insulin or drugs known to affect glucose metabolism
  • Intentionally restrict food intake
  • Have major medical or surgical event requiring hospitalization within the preceding 3 months
  • Have taken antibiotics for 3 months before the study period
  • Are a smoker
  • Are an overnight shift worker
  • Have any known food allergy (eg. anaphylaxis to peanuts)
  • Having active Tuberculosis (TB) or currently receiving treatment for TB
  • Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
  • Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC
  • Have poor veins impeding venous access
  • Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
  • History of surgery with metallic clips, staples or stents
  • Presence of cardiac pacemaker or other foreign body in any part of the body
  • History of claustrophobia particularly in a MRI scanner

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Cold Stimulation (CS)

Subjects will undergo a mild cold stimulation of about 14 degrees Celsius by wearing a cooling vest for approximately an hour daily for the next 12 weeks or 3 months.

Subject wear cooling vest to stay cool

实验性的:Browning Nutraceutical (BN)

Subjects will consume 2000mg of curcumin daily for the next 12 weeks or 3 months.

Subject will consume 2000mg of curcumin a naturally-occurring polyphenol antioxidant that is found in turmeric ginger rhizome root

实验性的:Cold Stimulation and Browning Nutraceutical (CSBN)

Subjects will undergo a mild cold stimulation of about 14 degrees Celsius by wearing a cooling vest for approximately an hour and consume 2000mg of curcumin daily for the next 12 weeks or 3 months.

Subject wear a cooling vest and consume 2000mg of curcumin

研究衡量的是什么?

主要结果指标

结果测量
大体时间
使用 18-FDG-PET/MRI 成像检测棕色脂肪组织激活的变化。
大体时间:冷刺激的第 0、12 和 24 周
冷刺激的第 0、12 和 24 周
通过红外成像检测棕色脂肪组织激活的变化
大体时间:冷刺激的第 0、12 和 24 周
冷刺激的第 0、12 和 24 周
使用全身热量计的能量消耗变化。
大体时间:冷刺激的第 0、12 和 24 周
冷刺激的第 0、12 和 24 周
使用 18-FDG-PET/MRI 成像检测棕色脂肪组织激活的变化。
大体时间:服用姜黄素的第 0、12 和 24 周
服用姜黄素的第 0、12 和 24 周
通过红外成像检测棕色脂肪组织激活的变化
大体时间:服用姜黄素的第 0、12 和 24 周
服用姜黄素的第 0、12 和 24 周
使用全身热量计的能量消耗变化。
大体时间:服用姜黄素的第 0、12 和 24 周
服用姜黄素的第 0、12 和 24 周
使用 18-FDG-PET/MRI 成像检测棕色脂肪组织激活的变化。
大体时间:第 0、12 和 24 周冷刺激和姜黄素消耗
第 0、12 和 24 周冷刺激和姜黄素消耗
通过红外成像检测棕色脂肪组织激活的变化
大体时间:第 0、12 和 24 周冷刺激和姜黄素消耗
第 0、12 和 24 周冷刺激和姜黄素消耗
使用全身热量计的能量消耗变化。
大体时间:第 0、12 和 24 周冷刺激和姜黄素消耗
第 0、12 和 24 周冷刺激和姜黄素消耗

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月15日

初级完成 (实际的)

2023年10月31日

研究完成 (估计的)

2028年8月16日

研究注册日期

首次提交

2020年10月14日

首先提交符合 QC 标准的

2020年10月17日

首次发布 (实际的)

2020年10月20日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2018/00823
  • 2018 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.