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| ID | Type | Description | Link |
|---|---|---|---|
| Universiti Putra Malaysia | Other Grant/Funding Number | Universiti Putra Malaysia |
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Background: The connection between gut health and diabetes status is increasingly recognized. Gut microbiota composition in diabetic differs from non-diabetic individuals. Interestingly, the level of glucose tolerance was associated with specific microbiota that was rarely found in healthy individuals. Probiotics is one of the functional foods believed to mediate their health promoting activities through modulating the composition of the gut health. Ingestion of probiotics has been shown not only to influence gut microbiota composition but also the secretion of the gut hormones and insulin resistance in animal models with limited trials in human. Supplementation with probiotic has also been shown not only affect glucose homeostasis, but improved other diabetes related comorbidities such as obesity, hypertension, and hyperlipidemia.
Objectives and hypotheses: To address this research gap, this Randomized Controlled Trial (RCT) is proposed to determine the efficacy of probiotic supplementations as adjuvant therapy to improve glucose homeostasis through modulating gut microbiota composition and gut hormones secretion in individuals with type 2 diabetes. We hypothesized that the probiotic supplementations will improve blood glucose control as well as other diabetes related co-morbidities in individuals with type 2 diabetes.
Methodology: This is a double blind randomized parallel group control trial with 3 months probiotic supplementation or placebo. After screening the eligible subjects will be selected. Then, after consent taking, subjects will be randomly assigned to either receive probiotic or supplement for 3 months. Measurements of blood parameters including glycemic control related parameters, lipid profile, renal profile, and liver function tests as well as three day diet recall, and anthropometry measurements will take place at baseline, after 6 weeks and after 12 months.
Expected Outcomes: Probiotic supplementation as an adjuvant therapy would improve glucose homeostasis and gut health as compared to the placebo and eventually will beneficially affect other diabetes related conditions. This study would provide avenue to identify the possibility of probiotic supplementations as an adjuvant therapy in the management of type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic | Experimental | subjects in this arm will receive probiotic supplementation for 12 weeks. |
|
| placebo | Placebo Comparator | subjects in this arm will receive placebo in identical sachets similar to probiotics which only differs in the codes mentioned on the label of sachets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | mix probiotic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hb A1c | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory markers | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lipoproteins | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Somayyeh Firouzi, master | Contact | 0060-172118565 | firouzi.som@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Somayyeh Firouzi, Master | Nutrition and Dietetic department, University Putra Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Kebangsaan Malaysia Medical Center | Recruiting | Kuala Lumpur | WP | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870148 | Derived | Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2. | |
| 26654906 | Derived | Firouzi S, Mohd-Yusof BN, Majid HA, Ismail A, Kamaruddin NA. Effect of microbial cell preparation on renal profile and liver function among type 2 diabetics: a randomized controlled trial. BMC Complement Altern Med. 2015 Dec 12;15:433. doi: 10.1186/s12906-015-0952-5. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | placebo |
|
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D019602 |
| Food and Beverages |