Clinical trial NCT01229891: Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients
Official title: Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink on Glycemic, Metabolic, Inflammatory, Immunity and Oxidative Stress Markers in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: vitamin D fortification
yogurt drink
type 2 diabetes
efficacy
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:Age:

* 30 to 50 years,
* Fasting blood glucose ≥ 126 mg/dl

Exclusion Criteria:

* Receiving vitamin D or calcium or omega-3 supplements within the last three months,
* On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months,
* Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism.
* Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications

Primary outcomes:
measure: Serum 25-hydroxyvitamin D
timeFrame: 12-week
Secondary outcomes:
measure: Fasting Serum Glucose (FSG)
timeFrame: 12-week
measure: Insulin
timeFrame: 12-week
measure: Hemoglobin A1c (HbA1c)
timeFrame: 12-week
measure: Serum Triglyceride (TG)
timeFrame: 12-week
measure: Serum Total Cholesterol (Tchol)
timeFrame: 12-week
measure: Serum Low Density Lipoprotein (LDL)
timeFrame: 12-week
measure: Serum High Density Lipoprotein (HDL)
timeFrame: 12-week
Other outcomes:
Locations:
Study officials:
affiliation: National Nutrition and Food Technology Research Institute
name: Tirang R. Neyestani, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.