Nutritional Intervention for Sustaining Health (NURISH) Trial

Официальное название

Nutritional Intervention for Sustaining Health (NURISH) Trial: Examining the Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) on Cognitive Performance, Metabolic Health, and Nutrient Status.

Обзор

The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults.The main questions it aims to answer are: Does the MIND diet improve cognitive performance and heart health relative to a control diet? Researchers will compare the MIND diet group to a control (a healthy diet that does not match the MIND diet) to see if the MIND provides more benefit to health. Participants will: Consume one meal that follows the MIND diet or a control meal every day for 3 months Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.

Подробное описание

The purpose of this study is to understand how a healthy diet is related to thinking ability and heart health. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. These meals will be delivered to participant homes using Daily Harvest meal delivery service. The study meals and smoothies will follow either a dietary pattern thought to improve brain and heart health (MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will come to 4 in-person laboratory visits to complete several computer-based tests of memory and attention while wearing an EEG cap. Participants will also be asked to complete an eye test, a heart rate and blood pressure assessment, a bone and body scan called DXA, and a blood draw at the beginning of the study and again at the end of the 12-week diet period.

Вмешательства

• Другое MIND Diet
  Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern.
• Другое Control Diet
  Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet.

Первичные конечные точки

• Attentional Accuracy [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Attentional Reaction Time [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Attentional Resource Allocation [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Attentional Processing Speed [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Fasting Blood Glucose [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Fasting Blood Triglycerides [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Fasting Blood HDL [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Blood Pressure [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Waist Circumference [Срок оценки: 12 weeks (Baseline vs Follow-Up)]

Вторичные конечные точки (2)

• Macular Pigment Optical Density [Срок оценки: 12 weeks (Baseline vs Follow-Up)]
• Visceral Adipose Tissue [Срок оценки: 12 weeks (Baseline vs Follow-Up)]

Критерии участия

Критерии включения

• 45-64 years of age
• 20/20 or corrected vision
• No food allergies or intolerances
• Not pregnant, lactating, or have given birth in the past 12 months
• Do not smoke, use tobacco, or abuse drugs
• Absence of liver or gastrointestinal diseases (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, and cancer
• Not currently taking oral hypoglycemic agents, or insulin
• No history of malabsorptive or bariatric surgery
• Cognitively intact with no prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
• Able to consume the study meals
• Not enrolled in another dietary, exercise, or medication study during the study

Критерии исключения

• Non-consent of participant
• Above 64 or below 45 years of age
• Vision not 20/20 or corrected
• Food allergies or intolerances
• Pregnant, lactating, or have given birth in the past 12 months
• Smoke, use tobacco, or abuse drugs
• Prior diagnosis of liver or gastrointestinal disease (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, or cancer
• Currently taking oral hypoglycemic agents or insulin
• History of malabsorptive or bariatric surgery
• Cognitively impaired and/or prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome)
• Unable to consume the study meals
• Concurrent enrollment in another dietary, exercise, or medication study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06437860 · NURISH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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