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}

Trials. 2024 Oct 7;25(1):660. doi: 10.1186/s13063-024-08486-y.

Abstract

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.

Keywords: Cardiovascular disease; Insomnia; MIND diet; Protocol; Sleep status; Type 2 diabetes.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Aged
  • Anxiety* / diet therapy
  • Anxiety* / psychology
  • Brain-Derived Neurotrophic Factor / blood
  • C-Reactive Protein / metabolism
  • Caloric Restriction
  • Cardiometabolic Risk Factors
  • Depression* / diet therapy
  • Depression* / psychology
  • Diabetes Mellitus, Type 2* / blood
  • Diabetes Mellitus, Type 2* / complications
  • Diabetes Mellitus, Type 2* / diet therapy
  • Diabetes Mellitus, Type 2* / psychology
  • Diet, Mediterranean
  • Dietary Approaches To Stop Hypertension
  • Female
  • Humans
  • Middle Aged
  • Obesity* / blood
  • Obesity* / complications
  • Obesity* / diet therapy
  • Obesity* / psychology
  • Obesity* / therapy
  • Oxidative Stress
  • Randomized Controlled Trials as Topic*
  • Sleep
  • Sleep Initiation and Maintenance Disorders* / blood
  • Sleep Initiation and Maintenance Disorders* / diet therapy
  • Sleep Initiation and Maintenance Disorders* / etiology
  • Sleep Initiation and Maintenance Disorders* / therapy
  • Sleep Quality
  • Time Factors
  • Treatment Outcome

Substances

  • Brain-Derived Neurotrophic Factor
  • C-Reactive Protein