The effect of MIND diet on sleep status, anxiety, depression, and cardiometabolic indices in obese diabetic women with insomnia: study protocol for a randomized controlled clinical trial {1}.
Study Goal
The researchers aimed to assess the effectiveness of the MIND dietary pattern on sleep quality, cardiometabolic indicators, and psychological indicators in overweight/obese women with type 2 diabetes mellitus and insomnia.
Results Summary
The abstract does not provide results, as the study appears to be in progress or not yet concluded.
Population
Overweight/obese women aged 30-65 with type 2 diabetes mellitus and insomnia.
Effective Dosage
Not specified (low-calorie diet variants: MIND low-calorie diet vs. standard low-calorie diet).
Duration
3 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
MIND dietary pattern | neutral | sleep quality, cardiometabolic indicators, and other psychological indicators | overweight/obese T2DM women with insomnia, aged 30-65 years | - | assess the effectiveness | #1 |
MIND low-calorie diet (MLCD) | neutral | sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators | overweight/obese T2DM women with insomnia, aged 30-65 years | - | will be assessed | #2 |
low-calorie diet (LCD) | neutral | sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators | overweight/obese T2DM women with insomnia, aged 30-65 years | - | will be assessed | #3 |
MIND diet | neutral | management of insomnia and cardiovascular problems of DM | overweight/obese T2DM women with insomnia, aged 30-65 years | - | investigate the capacity | #4 |
BACKGROUND: The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet is a plant-based and anti-inflammatory diet that has the ability to protect and manage cardiovascular and nervous system diseases. Regarding that insomnia and cardiovascular problems are x`common in type 2 diabetes mellitus (T2DM), the present study will assess the effectiveness of the MIND dietary pattern on sleep quality, cardiometabolic indicators, and other psychological indicators. METHODS: Forty-four overweight/obese T2DM women with insomnia, aged 30-65 years, will voluntarily participate in this randomized controlled trial and will be randomized to receive either a MIND low-calorie diet (MLCD) or a low-calorie diet (LCD) over a 3-month period. Before and after the study, sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators will be assessed. DISCUSSION: The use of dietary interventions in the management of T2DM complications is practical and safe. This research seeks to investigate the capacity of the MIND diet in the management of insomnia and cardiovascular problems of DM. It is expected that the results of this research will provide new perspectives on using an ideal dietary regimen to treat these health conditions. TRIAL REGISTRATION: IRCT20181111041611N8. Registered on August 7, 2023. https://www.irct.ir/trial/71772.