The Effect of Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Markers of Biological Age and Metabolic Health in Late-Perimenopausal and Menopausal Women: a Randomized Controlled Trial. The NutriAge Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Brain-derived neurotrophic factor concentration
研究概览
简要总结
The goal of this randomised controlled trial is to investigate whether Time-Restricted Eating (TRE) combined with a Low Glycaemic Index Mediterranean Diet can improve cognitive function, metabolic health, and biological ageing in late perimenopausal and menopausal women aged 45-75 years with a BMI ≥23 kg/m². It will consist of a 12-week intervention followed by a 12 week follow-up period.
Researchers will compare a group following the 16:8 time-restricted eating schedule and Low Glycaemic Index Mediterranean Diet to a control group (waiting list) receiving no dietary or meal-timing instructions to determine if these dietary strategies influence cognitive function, assessed via brain-derived neurotropic factor (BDNF) and cognitive function tests, metabolic outcomes, biological age, the gut microbiome, tender and swollen joint count and global health.
Participants will:
Follow a 16:8 time-restricted eating schedule (eating within an 8-hour window and fasting for 16 hours) if assigned to the intervention group.
Adhere to a tailored Low Glycaemic Index Mediterranean Diet and track meals using the Nutrium app.
Attend study visits at the University of Nicosia at Week 0, Week 12, and Week 24 for various assessments.
Provide biological samples, including blood samples at five specific intervals and stool samples at Week 0 and Week 12.
Complete multiple questionnaires regarding diet, lifestyle, sleep quality, physical activity, tender and swollen joints, and quality of life.
Undergo physical and cognitive assessments, such as CNS Vital Signs tests, blood pressure measurements, and body composition analysis.
The two groups will be compared to understand if the intervention improves outcomes and can thus be applied in this population group.
详细描述
This randomized controlled trial will run over a period of 24 weeks (6 months) and will be divided into two main phases: a 12-week intervention phase followed by a 12- week follow-up phase designed to assess long-term adherence and health outcomes. The participants will be randomized to one of two groups: the intervention group of a Time-Restricted Eating combined with a Low Glycaemic Index diet (TRE-LGI) group, and the control group which will not receive any dietary intervention.
During the intervention phase (Week 0 to Week 12), participants randomized to the TRE-LGI group will follow a structured eating plan. They will be instructed to consume all their meals within an 8-hour eating window each day and adhere to a low glycaemic index Mediterranean-style diet. Participants randomized to the control group will not receive any dietary intervention but will continue to be monitored for study purposes.
Assessments will be conducted at three time points during this phase. At baseline (Week 0), participants will complete a full set of evaluations, including the online Computerised Neurocognitive Testing tool CNS Vital Signs, metabolic markers (insulin sensitivity, and lipid profiles, C-reactive protein (CRP), BDNF assessment using Enzyme-Linked Immunosorbent Assay (ELISA) Test, biological ageing assessment using the N-glycome analysis (GlycanAge test), gut microbiome analysis from stool samples, body composition, blood pressure, waist circumference, sleep quality using the Pittsburgh Sleep Quality Index (PSQI), physical activity using the International Physical Activity Questionnaire-Short Form IPAQ-SF, tender and swollen joint count and Global Health using the PROMIS® Scale v1.2 - Global Health.
At Week 6, only the N-glycome composition analysis (GlycanAge) will be repeated to monitor changes in biological ageing.
At Week 12, all baseline assessments will be repeated to measure the effects of the intervention.
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
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in late perimenopausal or menopausal status Note: Late perimenopause is defined as two or more skipped cycles and at least 60 days of amenorrhea. Recent blood tests showing elevated FSH levels support eligibility for late perimenopause. Menopause is defined as 12 consecutive months without a menstrual cycle.
- •BMI ≥23 kg/m2
- •Age 45-75 years old
- •If using any medication, the dose should be stable for the previous 12 months
- •Able to use technology and follow the dietary plan
排除标准
- •Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD). Note: (Self-reported memory complaints are allowed).
- •On hormone replacement therapy (HRT)
- •Medical conditions that significantly affect cognitive or metabolic function including diagnosis of type 1 diabetes, severe metabolic disorders, cardiovascular disease, or neurodegenerative conditions, diagnosed eating disorders or severe mental health conditions.
- •Currently enrolled in another intervention.
- •Severe food allergies or dietary restrictions that would prevent adherence to the study diet.
- •History of substance abuse.
研究组 & 干预措施
Time-Restricted Low Glycaemic Index Diet
Participants in the Time-Restricted-Low-Glycaemic Index group will follow a 16:8 intermittent fasting regimen, where all meals are consumed within an 8-hour eating window. Their diet will also consist of low-glycaemic index foods following the principles of the Mediterranean diet. They will provided with individualized dietary plans through the Nutrium App and followed up regularly through the app.
干预措施: Time-Restricted Low-Glycaemic Index Diet (Other)
Control group
The Control Group will receive no dietary intervention during the 6-month trial but will be placed on a waiting list for future guidance if requested. Their dietary intake will be recorded through the Nutrium App.
结局指标
主要结局
Brain-derived neurotrophic factor concentration
时间窗: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Changes between the intervention and control group in the concentration of brain-derived neurotrophic factor assessed by Enzyme-linked Immunosorbent Assay
次要结局
- Cognitive function(Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period)
- Insulin resistance(Week 0 and Week 12 for the intervention period)
- Lipid profile(Week 0 and Week 12 for the intervention period)
- C-reactive protein (CRP)(Week 0 and Week 12 for the intervention period)
- IgG N-glycome composition analysis to assess GlycanAge(The test will be conducted at Week 0, 6, 12, 18, and 24 to monitor progressive changes in biological ageing throughout the 6-month study period.)
- Anthropometric measurements: Body weight, height, and calculation of the Body Mass Index(Week 0 and weekly thereafter until Week 24 for body weight and BMI, Week 0: Body height)
- Body composition analysis using Bioelectrical Impedance Analysis(Week 0 and Week 12 for the intervention phase and Week 24 for the follow-up phase)
- Gut microbiome(Week 0 and Week 12 for the intervention period)
- Blood pressure(Week 0 and Week 12 of the intervention period and Week 24 of the follow-up period)
- Sleep duration and quality(Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period)
- Tender and swollen joint count(Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period)
- Global Health(Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period)
研究者
Elena Philippou
Associate Professor Nutrition-Dietetics
University of Nicosia