Time-restricted Eating and High-intensity Interval Training for Metabolic Health in Adults With Overweight/Obesity

Официальное название

Time-restricted Eating and High-intensity Interval Training for Long-term Improvement in Metabolic Health

Обзор

This study will investigate the effects of 12 months periodised time-restricted eating combined with high-intensity interval training compared with a control group on fat mass in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive follow-up by telephone. Before randomisation, after 6 months and after 12 months, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed.

Вмешательства

• Поведенческое Time-restricted eating and high-intensity interval training
  1-month intense periods of maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \> 90 % heart rate maximum), separated by 3-month maintenance periods of time-restricted eating on 5 days per week and minimum 1 HIIT session per week. Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly during intense periods, and once monthly during maintenance periods.

Первичные конечные точки

• Total fat mass [Срок оценки: From baseline to after 12 months]

Вторичные конечные точки (12)

• Blood glucose [Срок оценки: From baseline to after 6 months and after 12 months]
• Total fat mass [Срок оценки: From baseline to after 6 months]
• Insulin [Срок оценки: From baseline to after 6 months and after 12 months]
• Average glucose levels [Срок оценки: From baseline to after 6 months and after 12 months]
• Blood cholesterol [Срок оценки: From baseline to after 6 months and after 12 months]
• LDL-cholesterol [Срок оценки: From baseline to after 6 months and after 12 months]
• HDL-cholesterol [Срок оценки: From baseline to after 6 months and after 12 months]
• Triglycerides [Срок оценки: From baseline to after 6 months and after 12 months]
• Cardiorespiratory fitness [Срок оценки: From baseline to after 6 months and after 12 months]
• Insulin sensitivity [Срок оценки: From baseline to after 6 months and after 12 months]
• Body mass [Срок оценки: From baseline to after 6 months and after 12 months]
• Fat-free mass [Срок оценки: From baseline to after 6 months and after 12 months]

Критерии участия

Критерии включения

• Body mass index ≥ 27 kg/m²
• Able to walk or ride a bike > 60 min

Критерии исключения

• On-going pregnancy
• Lactation within 24 weeks of study commencement
• High-intensity exercise ≥ 1/week
• Habitual eating window ≤12 hours/day
• Taking hypertension, glucose-, or lipid-lowering drugs
• Body mass variation ≥ 4 kg three months prior to study commencement
• Known diabetes mellitus (type 1 or 2) or cardiovascular disease
• Working night shifts

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Department of circulation and medical imaging, NTNU — Trondheim

Идентификаторы

NCT: NCT07036562 · 911308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗