Determination and comparison of the effect of omega-3, vitamin D and co-supplementation on glycemic status, serum lipids and psycological distress in reproductive-aged women with pre - diabetes and hypovitminosis D
A factorial Clinical trial with control group , triple-blinded and randomized phase 3 of the trial
Settings and conduct:
This study will be conducted at Shahid Rastravesh Health Center Laboratory in Karaj.
15-50 years old women with with pre - diabetes and hypovitminosis D if they have inclution criteria, are randomized into 4 groups according to the Stratified Block Randomization.
At baseline and after 8 weeks intervention , physical activity, DASS-21 and PSQI and a 3-day food record will be collected for each subject. Also blood pressure, weight, height and waist circumference will be measured.
At the beginning and at the end, a blood sample is used for estimating serum glucose indices , lipids and vitamin D.
Finally, in168 samples according to the appropriate statistical tests, the results of the comparison of efficacy of two these supplements are investigated.
Participants/Inclusion and exclusion criteria:
Women aged 15-50; FBS: 100-125 mg/ml; Vitamin D < 32 ng/mL; BMI < 30 ; Not intake of drugs that interfere with vitamin D oromega-3; Not Pregnancy; Not lactation; Absence of diagnosed systemic diseases
The first group (omega-3 and vitamin D placebo), the second group (Omega-3 placebo and vitamin D supplement), the third group (omega-3 supplement and vitamin D placebo), and the fourth group (supplement of omega-3 and vitamin D)
Main outcome variables:
glycemic status (FBS, insulin, HOMA- IR, HOMA- B), lipid profile (triglyceride, total cholesterol, HDL cholesterol, LDL-cholesterol) and psychological distress (depression, anxiety, stress and quality of sleep)
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