Time-restricted Eating (TRE) and Protein in Older Adults

Официальное название

The Effects of Time-restricted Eating (TRE) With and Without Additional Protein on Body Composition, Muscle Function and Markers of Metabolic Health in Older Adults

Обзор

The aim this study is to investigate the effects of time-restricted eating (TRE) on body composition, muscle function and markers of metabolic health of adults over 60 years old. This study will compare different variations of TRE - with and without an additional protein. This study involves attending two study days at the University of Surrey for baseline and end-of-intervention measurement of body composition using a gold-standard dual energy x-ray absorptiometry (DEXA) scan; muscle function using hand grip strength and 30-second sit-to-stand tests; weight. A blood sample will be taken at each study visit to measure markers of lipid and glucose control, and insulin sensitivity. Participants will be randomly allocated to one of four study groups: * control group: maintain habitual dietary patterns * TRE group: fast for 16 hours overnight, eat between 12-8pm * TRE + Protein (AM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the morning * TRE + Protein (PM): fast for 16 hours overnight, eat between 12-8pm; take a 30g plant-based protein supplement in the afternoon Participants will be asked to follow the intervention according to their allocated group for 8 weeks.

Вмешательства

• Другое TRE
  * Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight. * Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea/coffee, 0-calorie soft drinks.
• Другое ProtAM TRE
  * Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight. * Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea/coffee, 0-calorie soft drinks. * In addition, they will be asked to consume a protein drink containing 30g protein in the morning, 2 hours before the 8-hour eating window opens at 12pm (i.e. at 10am).
• Другое ProtPM TRE
  * Participants will be asked to follow a 16:8 TRE protocol, consuming all their daily within 8 hours, between 12 and 8pm, and fast for 16 hours overnight. * Outside of the eating window, participants will be allowed to consume energy-free drinks only, i.e. water, black tea/coffee, 0-calorie soft drinks. * In addition, they will be asked to consume a protein drink containing 30g protein in the afternoon, either 2 hours after their first meal or 2 hours before their last meal of the day.

Первичные конечные точки

• Change from baseline in body composition at 2 months using whole-body dual-energy x-ray absorptiometry (DEXA) [Срок оценки: For 8 weeks of the assigned study intervention]
• Change from baseline in muscle function at 2 months [Срок оценки: At the start and end of 8 weeks of the assigned study intervention]
• Change from baseline in muscle function at 2 months [Срок оценки: At the start and end of 8 weeks of the assigned study intervention]

Вторичные конечные точки (5)

• Change in fasting glucose control indicators [Срок оценки: At the start and end of 8 weeks of the assigned study intervention]
• Change from baseline in insulin sensitivity at 2 months [Срок оценки: At the start and end of 8 weeks of the assigned study intervention]
• Change from baseline in lipid metabolism at 2 months [Срок оценки: At the start and end of 8 weeks of the assigned study intervention]
• Change from baseline in diet composition at 2 months [Срок оценки: At the start, mid-point (week 4) and end of 8 weeks of the assigned study intervention]
• Feasibility of the assigned TRE intervention [Срок оценки: at the end of the 8 week intervention]

Критерии участия

Критерии включения

• Gender: male and female
• Age range: 60 years or older
• Fasting for 12 or less hours on a daily basis
• BMI range: 23-30 kg/m2
• Weight stability: no more than 3kg weight gain or loss in the past 3 months
• Regular eating pattern, i.e. 3 meals a day
• Able to prepare the protein supplement

Критерии исключения

• Any of the following present (in line with exclusion criteria used in previous TRE research in older adults):

• known renal impairment
• heart attack or stroke in the past three months
• continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
• rheumatoid arthritis
• Parkinson's disease
• active treatment for cancer in the past year
• insulin dependent diabetes mellitus
• taking medications that preclude fasting for 16 h
• actively trying or planning to lose weight
• history of an eating disorder
• outside of stated age or BMI range
• fasting for longer than 12 hours on a daily basis
• unable to prepare the protein supplement
• extreme morning/evening chronotype
• sleep disorders
• regular meal skipping
• history of difficulty having a blood sample taken
• Recent exposure to high-dose radiation
• Vigorous exercise on more than 3 occasions a week

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

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• University of Surrey — Guildford

Идентификаторы

NCT: NCT07314658 · 361019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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