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临床试验/NCT04383704
NCT04383704已完成不适用

Effect of MIND Diet Intervention on Cognitive Performance and Brain Structure in Healthy Obese Women: A Randomized Controlled Trial

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Assessment of changes in cognitive performance tests measured by a complex paper cognitive battery at the baseline and after three months follow up.

研究概览

简要总结

This single-center, randomized trial examined the effect of MIND diet intervention on cognition and brain structure changes of healthy obese women over three months. The intervention group was lea to calorie-restricted modified by the MIND diet, and the control group received a calorie-restricted standard diet. The primary end-point was an assessment of cognitive performances measured with a comprehensive cognitive test battery. Secondary end-points were voxel-based morphometry to quantify the differences in brain structures. Our results revealed MIND diet could improve working memory, verbal recognition memory, and attention, more in comparison with the control group. Results also suggest that an increase in inferior frontal gyrus in the MIND diet group. Our study, for the first time, underlined that good adherence to the MIND diet as well as calorie restriction could reverse the destructive effect of obesity on cognition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Middle-aged women (40-60 years),
  • •Without any metabolic complication,
  • •BMI 30-35 kg/m2,
  • •MMSE ≥ 24,
  • •And no history of severe untreated medical, neurological, and psychiatric diseases which may interfere with the study intervention.

排除标准

  • •Have gastrointestinal problems,
  • •Participate in weight loss programs,
  • •Use weight loss drugs in the last three months,
  • •Had not wholly followed the dietary pattern,
  • •Became pregnant,
  • •And undergo special medical treatments during a three months study.

研究组 & 干预措施

calorie-restricted modified MIND diet

Experimental

This arm received instruction in modifying the content of their diet to meet MIND pattern guidelines.

干预措施: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) (Other)

calorie-restricted standard control diet

Active Comparator

They instructed to calorie-restricted diet alone.

干预措施: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) (Other)

结局指标

主要结局

Assessment of changes in cognitive performance tests measured by a complex paper cognitive battery at the baseline and after three months follow up.

时间窗: Baseline and after three months.

All of the participants were tested on a complex paper-based battery of neurocognitive tests to examine changes in cognitive performance in different domains at baseline and after three months follow up. These tests include Forward Digit Span Task (FDST), Backward Digit Span Task (BDST), Letter Number Sequencing Task (LNST), Symbol Digit Modality Task (SDMT), Auditory Verbal Learning Test (AVLT) and Stroop task.

次要结局

  • Assessment of changes in brain structures measured by Magnetic Resonance Imaging (MRI) baseline and after three months follow up.(Baseline and after three months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Hassan Eftekhari

PHD. professor of clinical nutrition (clinical nutrition, school of nutrition and food science)

Shiraz University of Medical Sciences

研究点 (1)

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