Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).
ninety diabetic patients will be selected. Patients who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Patients will be assigned randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary outcome is prevention of long-term diabetic complications.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain yogurt drink | Placebo Comparator | daily intake of two bottle (250 mL) plain yogurt drink |
|
| vitamin D-fortified yogurt drink | Experimental | daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL |
|
| vitamin D-calcium yogurt drink | Experimental | daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plain yogurt drink | Dietary Supplement | daily intake of two bottle of plain yogurt drink |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25-hydroxyvitamin D | 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Serum Glucose (FSG) | 12-week | |
| Insulin | fasting serum insulin concentration | 12-week |
| Hemoglobin A1c (HbA1c) |
Not provided
Inclusion Criteria:Age:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tirang R. Neyestani, PhD | National Nutrition and Food Technology Research Institute | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34077684 | Derived | Nikooyeh B, Shariatzadeh N, Rismanchi M, Hollis BW, Neyestani TR. Daily intake of yogurt drink fortified either with vitamin D alone or in combination with added calcium causes a thyroid-independent increase of resting metabolic rate in adults with type 2 diabetes: a randomized, double-blind, clinical trial. Appl Physiol Nutr Metab. 2021 Nov;46(11):1363-1369. doi: 10.1139/apnm-2021-0248. Epub 2021 Jun 2. | |
| 23875809 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Plain Yogurt Drink | daily intake of two bottle (250 mL) plain yogurt drink |
| FG001 | Vitamin D-fortified Yogurt Drink | daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL |
| FG002 | Vitamin D-calcium Yogurt Drink | daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Plain Yogurt Drink | daily intake of two bottle (250 mL) plain yogurt drink |
| BG001 | Vitamin D-fortified Yogurt Drink | daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum 25-hydroxyvitamin D | Posted | Mean | Standard Deviation | nmol/L | 12-week |
|
during the intervention (12-week)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plain Yogurt Drink | daily intake of two bottle (250 mL) plain yogurt drink |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T Neyestani | National nutrition and food technology institute | 0982122376471 | neytr@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| vitamin D fortified yogurt drink | Dietary Supplement | daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL |
|
|
| vitamin D-calcium yogurt drink | Dietary Supplement | daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package |
|
|
| 12-week |
| Serum Triglyceride (TG) | 12-week |
| Serum Total Cholesterol (Tchol) | 12-week |
| Serum Low Density Lipoprotein (LDL) | 12-week |
| Serum High Density Lipoprotein (HDL) | 12-week |
| Derived |
| Heravifard S, Neyestani TR, Nikooyeh B, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Zahedirad M, Tayebinejad N, Salekzamani S, Khalaji N, Gharavi A. Regular consumption of both vitamin D- and calcium- and vitamin D-fortified yogurt drink is equally accompanied by lowered blood lipoprotein (a) and elevated apoprotein A1 in subjects with type 2 diabetes: a randomized clinical trial. J Am Coll Nutr. 2013;32(1):26-30. doi: 10.1080/07315724.2013.767659. |
| 22442277 | Derived | Neyestani TR, Nikooyeh B, Alavi-Majd H, Shariatzadeh N, Kalayi A, Tayebinejad N, Heravifard S, Salekzamani S, Zahedirad M. Improvement of vitamin D status via daily intake of fortified yogurt drink either with or without extra calcium ameliorates systemic inflammatory biomarkers, including adipokines, in the subjects with type 2 diabetes. J Clin Endocrinol Metab. 2012 Jun;97(6):2005-11. doi: 10.1210/jc.2011-3465. Epub 2012 Mar 22. |
| 21289226 | Derived | Nikooyeh B, Neyestani TR, Farvid M, Alavi-Majd H, Houshiarrad A, Kalayi A, Shariatzadeh N, Gharavi A, Heravifard S, Tayebinejad N, Salekzamani S, Zahedirad M. Daily consumption of vitamin D- or vitamin D + calcium-fortified yogurt drink improved glycemic control in patients with type 2 diabetes: a randomized clinical trial. Am J Clin Nutr. 2011 Apr;93(4):764-71. doi: 10.3945/ajcn.110.007336. Epub 2011 Feb 2. |
| BG002 | Vitamin D-calcium Yogurt Drink | daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 25-hydroxyvitamin D | Mean | Standard Deviation | nmol/L |
|
| Fasting serum glucose (FSG) | Fasting serum glucose concentration | Mean | Standard Deviation | mg/dL |
|
| Insulin | Fasting serum Insulin concentration | Mean | Standard Deviation | mU/L |
|
| HbA1c | Hemoglobin A1c | Mean | Standard Deviation | percent |
|
| TG | serum triglyceride concentration | Mean | Standard Deviation | mg/dL |
|
| Tchol | serum total cholesterol concentration | Mean | Standard Deviation | mg/dL |
|
| LDL | serum low density lipoprotein concentration | Mean | Standard Deviation | mg/dL |
|
| HDL | serum High density lipoprotein concentration | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Fasting Serum Glucose (FSG) | Posted | Mean | Standard Deviation | mg/dL | 12-week |
|
|
|
| Secondary | Insulin | fasting serum insulin concentration | Posted | Mean | Standard Deviation | mU/L | 12-week |
|
|
|
| Secondary | Hemoglobin A1c (HbA1c) | Posted | Mean | Standard Deviation | percent | 12-week |
|
|
|
| Secondary | Serum Triglyceride (TG) | Posted | Mean | Standard Deviation | mg/dL | 12-week |
|
|
|
| Secondary | Serum Total Cholesterol (Tchol) | Posted | Mean | Standard Deviation | mg/dL | 12-week |
|
|
|
| Secondary | Serum Low Density Lipoprotein (LDL) | Posted | Mean | Standard Deviation | mg/dL | 12-week |
|
|
|
| Secondary | Serum High Density Lipoprotein (HDL) | Posted | Mean | Standard Deviation | mg/dL | 12-week |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Vitamin D-fortified Yogurt Drink | daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL | 0 | 30 | 0 | 30 |
| EG002 | Vitamin D-calcium Yogurt Drink | daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL | 0 | 30 | 0 | 30 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |