| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obesity | Drug: TCM-FMD Other: FMD | Phase 2 |
Background:Fasting-mimiking Diet (FMD) is a plant-based diet designed to attain fasting-like effect, firstly proposed on 2015[1]. It requires people to limit calorie intake for 5 continuous days, and then return to their normal diet after completion about 25 days until the next cycle. In a clinical trial[2], three FMD cycles reduced body weight, trunk and body fat, and reduced blood pressure, fasting blood glucose, triglycerides and total cholesterol. On the other hand, in the theory of physique of TCM theory, overweight/obesity is usually considered to be phlegm-dampness type.
Objective: We assume that using medicinal-edible plants which was considered to dispel dampness(such as fuling, shanyao, etc.) as FMD's proprietary formulations can enhance the effect of FMD on improve people's characteristic features of metabolic syndrome.
Methods: A 12-week, single-center, pilot study will be conducted to test the study objectives.A new diet is carried. It is a fasting-mimicking diet combined with a "dispelling dampness" meal replacement. Because the theory of applying traditional Chinese medicine combined with FMD, we call it TCM-FMD, the main ingredient of the "wet diet" meal package is millet. Brown rice, oats, purple sweet potato, alfalfa, yam, hazelnut, etc. For comparison, we also designed FMD to make some cereals (including millet, purple potato, oatmeal, walnut, etc.) without a moisturizing effect into a "grain package" as a control group. Both groups were administered using the FMD diet model. At the same time, a group of normal diets was also designed as a blank control group. The primary outcome measure for the study was weight; secondary outcome measures included: waist circumference, blood pressure, triglycerides, total cholesterol and fasting blood glucose, quality of life (evaluated by physical fitness scale and SF-36); safety indicators included: liver and kidney Features, etc. Both groups were subjected to caloric restriction (5 days, daily calorie about 800kcal) and normal diet (dietitian for healthy diet guidance), and the blank control group was given a normal diet.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effect and Safety of Fasting-Mimicking Diet Combined With a "Dispelling Dampness" Meal Replacement in Phlegm-Dampness Type Overweight/Obesity Patients: A Randomized Controlled Study(EASTAR) |
| Actual Study Start Date : | June 21, 2019 |
| Estimated Primary Completion Date : | January 31, 2020 |
| Estimated Study Completion Date : | January 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: TCM-FMD
Apply fastening-mimicking diet combined with a "dispelling dampness" meal replacement. For the convenience of implementation, a cycle of 4 weeks. The first 5 days of each cycle is the calorie restriction stage (daily calorie about 800kcal). The traditional Chinese medicine with dampness effect is used as the main source of calories in this stage. The normal diet is carried out under the guidance of a professional dietitian for the next 23 days. Study for 12 weeks.
|
Drug: TCM-FMD
Apply fastening-mimicking diet combined with a "dispelling dampness" meal replacement. For the convenience of implementation, a cycle of 4 weeks. The first 5 days of each cycle is the calorie restriction stage (daily calorie about 800kcal). The traditional Chinese medicine with dampness effect is used as the main source of calories in this stage. The normal diet is carried out under the guidance of a professional dietitian for the next 23 days. Study for 12 weeks.
|
|
Active Comparator: FMD
A "grain package" is used to replace the "dispelling dampness" meal replacement, and the other thing is the same as the proposal in TCM-FMD.
|
Other: FMD
A "grain package" is used to replace the "dispelling dampness" meal replacement, and the other thing is the same as the proposal in TCM-FMD.
|
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No Intervention: Normal diet
Carrying out normal diet under the guidance of a dietitian, for 12 weeks.
|
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| China, Guangdong | |
| Guangdong Provincial Hospital of Chinese Medicine | |
| Guangzhou, Guangdong, China, 510000 | |
| Study Director: | Yuanqi Zhao, MD | Guangdong Provincial Hospital of Traditional Chinese Medicine |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 20, 2019 | ||||
| First Posted Date ICMJE | July 23, 2019 | ||||
| Last Update Posted Date | December 27, 2019 | ||||
| Actual Study Start Date ICMJE | June 21, 2019 | ||||
| Estimated Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Body weight [ Time Frame: Change from baseline to day 6/week 4/week 12 ] Measuring the fasting weight of the day at the required time point and measured by the same instrument
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect and Safety of TCM-FMD in Phlegm-Dampness Type Overweight/Obesity Patients(EASTAR) | ||||
| Official Title ICMJE | Effect and Safety of Fasting-Mimicking Diet Combined With a "Dispelling Dampness" Meal Replacement in Phlegm-Dampness Type Overweight/Obesity Patients: A Randomized Controlled Study(EASTAR) | ||||
| Brief Summary | The primary aim of this study is to is to determine if a diet (TCM-FMD) which combine fasting-mimicking diet (FMD) with "dispelling dampness" meal replacement (a meal replacement made up of traditional Chinese medicine) is the effective dietary strategy for treatment of phlegm-dampness type overweight/obese patients. A three months randomized trial will be used to observe weight loss generated by TCM-FMD and FMD. And a group keeping a normal diet will be set as a blank control. Through comparison, we aim at examining the effects of interventions on weight and metabolic disease risk factors (plasma lipids, fasting glucose, blood pressure) The secondary aim of this study is to evaluate the safety of TCM-FMD. | ||||
| Detailed Description |
Background:Fasting-mimiking Diet (FMD) is a plant-based diet designed to attain fasting-like effect, firstly proposed on 2015[1]. It requires people to limit calorie intake for 5 continuous days, and then return to their normal diet after completion about 25 days until the next cycle. In a clinical trial[2], three FMD cycles reduced body weight, trunk and body fat, and reduced blood pressure, fasting blood glucose, triglycerides and total cholesterol. On the other hand, in the theory of physique of TCM theory, overweight/obesity is usually considered to be phlegm-dampness type. Objective: We assume that using medicinal-edible plants which was considered to dispel dampness(such as fuling, shanyao, etc.) as FMD's proprietary formulations can enhance the effect of FMD on improve people's characteristic features of metabolic syndrome. Methods: A 12-week, single-center, pilot study will be conducted to test the study objectives.A new diet is carried. It is a fasting-mimicking diet combined with a "dispelling dampness" meal replacement. Because the theory of applying traditional Chinese medicine combined with FMD, we call it TCM-FMD, the main ingredient of the "wet diet" meal package is millet. Brown rice, oats, purple sweet potato, alfalfa, yam, hazelnut, etc. For comparison, we also designed FMD to make some cereals (including millet, purple potato, oatmeal, walnut, etc.) without a moisturizing effect into a "grain package" as a control group. Both groups were administered using the FMD diet model. At the same time, a group of normal diets was also designed as a blank control group. The primary outcome measure for the study was weight; secondary outcome measures included: waist circumference, blood pressure, triglycerides, total cholesterol and fasting blood glucose, quality of life (evaluated by physical fitness scale and SF-36); safety indicators included: liver and kidney Features, etc. Both groups were subjected to caloric restriction (5 days, daily calorie about 800kcal) and normal diet (dietitian for healthy diet guidance), and the blank control group was given a normal diet. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE |
60 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | January 31, 2020 | ||||
| Estimated Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04029571 | ||||
| Other Study ID Numbers ICMJE | tcmfmd | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Yuanqi Zhao,MD, Guangdong Provincial Hospital of Traditional Chinese Medicine | ||||
| Study Sponsor ICMJE | Guangdong Provincial Hospital of Traditional Chinese Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Guangdong Provincial Hospital of Traditional Chinese Medicine | ||||
| Verification Date | December 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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