| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 Overweight and Obesity | Dietary Supplement: Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance Dietary Supplement: A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance | Not Applicable |
The prevalence of Type 2 Diabetes Mellitus is increasing year by year in the world, causing harm to patients' health and making a huge consumption of medical expenses. Obesity is one of the most obvious risk factors for Type 2 Diabetes Mellitus. There are also many positive studies on nutritional intervention for the treatment of obese patients with Type 2 Diabetes Mellitus at home and abroad. The effect of nutritional meal replacement to relieve the disease has also been widely recognized.
Light-Fat Rice® is a new type of nutritious staple food taking rice, konjac, marine fish oligopeptide powder, inulin and yeast as raw material. Also,there is a protein solid beverage,Active Peptide®,containing soy protein isolate, soy peptide powder, oligofructose,water-soluble dietary fiber and other ingredients,such as multi-vitamin. When used together, it can provide balanced nutrition for the human body while satisfying low fat and high protein. In this study, a 4-week, randomized, double-blind, controlled clinical trial will be conducted to investigate the effects of Light-Fat Rice® combined with Active Peptide® intervention on insulin resistance in overweight/obese diabetic patients and their effects on prognosis,further explaining its intervention mechanism theoretically. Based on a previous review of similar literature studies, 60 of these patients will be enrolled and randomly assigned to the intervention and control groups at 1:1. Among them, the intervention group will be given 80g of Light-Fat Rice® staple food meal as an independent staple food or mixed in the staple food combined with 2 packs Active Peptide®, and the control group was given the same energy-equivalent staple food produced by the same manufacturer daily with 2 packs maltodextrin. Both groups are provided with a same lifestyle guidance by professional physicians based on the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China 2017", including reasonable diet, exercise guidance, and organization of health education.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The diet will be administered by a professional physician (intervention group:Light-Fat Rice® combined with Active Peptide®; control group: staple food of equal energy containing a small amount of dietary fiber combined with comparable energy maltodextrin) with a lifestyle guidance,same in both groups, to assist in diabetes management. The method of taking the product can be divided into two parts.And a dynamic blood glucose transient monitor would be worn for all patients at the 3rd week to record the patients's dynamic blood glucose changes including preprandial, postprandial (every 15 minutes), before and after exercise (every 30 minutes).Besides these,the patients would be asked to record dietary and exercise diary for 3 days(including one weekend at least) each week also. |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Light-Fat Rice® on Blood Glucose in Overweight/Obese Patients With Type 2 Diabetes Mellitus and Related Mechanisms |
| Actual Study Start Date : | June 20, 2019 |
| Actual Primary Completion Date : | June 20, 2020 |
| Estimated Study Completion Date : | July 20, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention group
The Light-Fat Rice® group
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Dietary Supplement: Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance
Subjects will be given the Light-Fat Rice® combined with Active Peptide® with a lifestyle guidance to assist diabetes management. The method of taking the product has two parts: 1.Light-Fat Rice®: 80g (1 pack) per day as a staple meal replacement, used as a separate staple food or mixed with other staple foods, taking 4 weeks; 2.Active Peptide®: 20g (2 packs) per day (1 pack each morning and evening), served with 300ml of 40°C warm water each time before meals and take it for 4 weeks.
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Placebo Comparator: Control group
The comparable energy staple food group
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Dietary Supplement: A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance
A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin (both produced by the same manufacturer) with a lifestyle guidance will be given by the professional to assist in diabetes management. The product is taken as follows: 1.equal-energy staple food containing a small amount of dietary fiber: 80g (1 pack) per day, used as an independent staple food or mixed with other staple foods, taking for 4 weeks; 2.equal-energy maltodextrin: 20g(2 packs) per day(1 pack each morning and evening),take it with 300ml of 40°C warm water for 4 weeks.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Comply with the diagnostic criteria for type 2 diabetes in the 1999 WHO Diabetes Diagnosis and Classification Standard:
Clear clinical record of fasting blood glucose (FPG) ≥ 7mmol / L or 75g OGTT(2h) ≥ 11.1mmol / L;
Exclusion Criteria:
Laboratory inspection:
Liver function: AST and / or ALT ≥ 2.5 × ULN; Renal function: Cr>1.2×ULN;
| China, Beijing | |
| Dongcheng district,Peking union medical college hospital | |
| Beijing, Beijing, China, 100010 | |
| Principal Investigator: | Wei Chen, M.D. | Peking Union Medical College Hospital |
| Tracking Information | |||||||||||||||
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| First Submitted Date ICMJE | May 24, 2019 | ||||||||||||||
| First Posted Date ICMJE | June 4, 2019 | ||||||||||||||
| Last Update Posted Date | September 28, 2020 | ||||||||||||||
| Actual Study Start Date ICMJE | June 20, 2019 | ||||||||||||||
| Actual Primary Completion Date | June 20, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
| Current Primary Outcome Measures ICMJE |
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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 |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||||
| Descriptive Information | |||||||||||||||
| Brief Title ICMJE | A Clinical Trial of Overweight/Obesity With Type 2 Diabetes | ||||||||||||||
| Official Title ICMJE | Effect of Light-Fat Rice® on Blood Glucose in Overweight/Obese Patients With Type 2 Diabetes Mellitus and Related Mechanisms | ||||||||||||||
| Brief Summary | In the previous intervention studies of Type 2 Diabetes Mellitus patients, changes in blood glucose and insulin resistance profiles before and after intervention indicated that different intervention methods had different effects on outcomes. Therefore, this study intends to explore the effect of the Light-Fat Rice®combined with Active Peptide® on the level of insulin resistance in overweight/obese diabetic patients and its effect on the outcome through a 4-week, randomized, double-blind, controlled clinical trial, further elucidating its intervention mechanism theoretically. The study predicts that dynamic blood glucose(mean blood glucose) and glycosylated albumin will significantly different between the control group and the intervention group.And insulin resistance levels, blood lipids and other indicators wil be improved, and the test group was superior to the control group.All of these will contribute to more scientific and effective Type 2 Diabetes Mellitus's management. | ||||||||||||||
| Detailed Description |
The prevalence of Type 2 Diabetes Mellitus is increasing year by year in the world, causing harm to patients' health and making a huge consumption of medical expenses. Obesity is one of the most obvious risk factors for Type 2 Diabetes Mellitus. There are also many positive studies on nutritional intervention for the treatment of obese patients with Type 2 Diabetes Mellitus at home and abroad. The effect of nutritional meal replacement to relieve the disease has also been widely recognized. Light-Fat Rice® is a new type of nutritious staple food taking rice, konjac, marine fish oligopeptide powder, inulin and yeast as raw material. Also,there is a protein solid beverage,Active Peptide®,containing soy protein isolate, soy peptide powder, oligofructose,water-soluble dietary fiber and other ingredients,such as multi-vitamin. When used together, it can provide balanced nutrition for the human body while satisfying low fat and high protein. In this study, a 4-week, randomized, double-blind, controlled clinical trial will be conducted to investigate the effects of Light-Fat Rice® combined with Active Peptide® intervention on insulin resistance in overweight/obese diabetic patients and their effects on prognosis,further explaining its intervention mechanism theoretically. Based on a previous review of similar literature studies, 60 of these patients will be enrolled and randomly assigned to the intervention and control groups at 1:1. Among them, the intervention group will be given 80g of Light-Fat Rice® staple food meal as an independent staple food or mixed in the staple food combined with 2 packs Active Peptide®, and the control group was given the same energy-equivalent staple food produced by the same manufacturer daily with 2 packs maltodextrin. Both groups are provided with a same lifestyle guidance by professional physicians based on the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China 2017", including reasonable diet, exercise guidance, and organization of health education. |
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| Study Type ICMJE | Interventional | ||||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: The diet will be administered by a professional physician (intervention group:Light-Fat Rice® combined with Active Peptide®; control group: staple food of equal energy containing a small amount of dietary fiber combined with comparable energy maltodextrin) with a lifestyle guidance,same in both groups, to assist in diabetes management. The method of taking the product can be divided into two parts.And a dynamic blood glucose transient monitor would be worn for all patients at the 3rd week to record the patients's dynamic blood glucose changes including preprandial, postprandial (every 15 minutes), before and after exercise (every 30 minutes).Besides these,the patients would be asked to record dietary and exercise diary for 3 days(including one weekend at least) each week also. Masking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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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 |
61 | ||||||||||||||
| Original Estimated Enrollment ICMJE |
60 | ||||||||||||||
| Estimated Study Completion Date ICMJE | July 20, 2021 | ||||||||||||||
| Actual Primary Completion Date | June 20, 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 75 Years (Adult, Older Adult) | ||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
| 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 | NCT03972904 | ||||||||||||||
| Other Study ID Numbers ICMJE | HS-1910 | ||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Wei Chen, Peking Union Medical College Hospital | ||||||||||||||
| Study Sponsor ICMJE | Peking Union Medical College Hospital | ||||||||||||||
| Collaborators ICMJE | Hebei Dongfangyun Health Management Co.,Ltd | ||||||||||||||
| Investigators ICMJE |
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| PRS Account | Peking Union Medical College Hospital | ||||||||||||||
| Verification Date | September 2020 | ||||||||||||||
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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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