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The effect of MIND diet in diabetic patients with insomnia

The effect of MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet pattern on sleep status, anxiety, depression, and cardiometabolic indices in overweight or obese diabetic women with insomnia: A randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181111041611N8
Enrollment
44
Registered
2023-08-07
Start date
2023-08-19
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes. Type 2 diabetes mellitus with other specified complications

Interventions

Intervention 1: Intervention group: Receive a low-calorie MIND diet for 3 months. The required energy will be calculated based on the World Health Organization equations and 500 kcal will be deducted

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women with type 2 diabetes Desire to participate in the study Age range from 30 to 65 years old Body mass index between 25 and 35 kg/m2 Suffering from insomnia disorder, based on the Insomnia Severity Index (ISI) questionnaire, with scores above 7

Exclusion criteria

Exclusion criteria: Insulin use Pregnancy and lactation Alcohol and smoking Sleep apnea Shift work Special diets and medications for weight loss in the last 3 months Suffering from other endocrine, metabolic, kidney and neurological diseases Taking medications (sedatives, painkillers, sleeping pills, etc.) other than blood sugar, lipid, and blood pressure lowering medications

Design outcomes

Primary

MeasureTime frame
Sleep quality. Timepoint: Baseline and End-of-trial. Method of measurement: The Pittsburgh Sleep Quality Index.

Secondary

MeasureTime frame
Depression-anxiety-stress. Timepoint: Baseline and End-of-trial. Method of measurement: Depression Anxiety and Stress Scale-21 questionnaire.;Fasting blood sugar. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method.;HbA1C. Timepoint: Baseline and End-of-trial. Method of measurement: Photometric method.;Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;Triglyceride. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method.;Total cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method.;HDL Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic method.;Brain-derived neurotrophic factor. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;Cortisol. Timepoint: Baseline and End-of-trial. Method of measurement: Elisa.;Total Antioxidant Capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method.;Total oxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method.;GSH-Px. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method.;Catalase. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method.;SOD. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method.;MDA. Timepoint: Baseline and End-of-trial. Method of measurement: Calorimetric method.;Quality of life. Timepoint: Baseline and End-of-trial. Method of measurement: 36-Item Short Form Survey.;LDL Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Friedewald.;Blood pressure. Timepoint: Baseline and End-of-trial. Method of measurement: Sphygmomanometer.;Weight. Timepoint: Baseline and End-of-trial. Method of measurement: Digital scale.;Body mass index. Timepoint: Baseline and End-of-trial. Method of measurement: Dividing weight (in kilog

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mostafa Nachvak

Kermanshah University of Medical Sciences

smnachvak@hotmail.com+98 83 3710 2003

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026