ICOPE INTENSE-K Pilot Study

Официальное название

A ICOPE Intense Program Combined With Ketone Ester Pilot Study

Обзор

ICOPE could constitute the reference model of care for healthy aging. More specifically, our hypothesis is that the intervention implemented in ICOPE may directly or indirectly prevent immuno-senescence, the loss of mobility and the cognitive decline. In future Geroscience clinical trials, ICOPE-Intense could become a benchmark to reduce the rate of aging with a strong non-pharmacological intervention and state a reference intervention to compare with new gerotherapeutic drugs.

Подробное описание

In this pilot study, the concept of prevention proposed by the WHO, for everyday life is taken to the extreme to be able to judge what is the maximum effect size on key functions of aging (mobility, cognition, immunity) that can be expected and achieved by a nonpharmacological intervention. The results obtained will constitute reference data for the future, during the investigation on new gerotherapeutic drugs or other nonpharmacological interventions. Taking into account the hypothesis of a synergistic effect between Ketones and non-pharmacological intervention, the intense ICOPE program makes it possible to study the effect size of Ketones under optimal experimental conditions.

Вмешательства

• Другое ICOPE intense intervention
  The ICOPE-intense intervention (45 hours centre-based (in-group and in-person) multidomain intervention, everyday home-based lifestyle improvement, and weekly individual phone/video call for support)
• Пищевая добавка Ketone Ester (KE) supplementation
  12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
• Пищевая добавка Placebo
  2.5 g of nonketogenic canola oil
• Пищевая добавка Vitamin D3
  2 sprays (i.e. 2000 iu) per day in the morning for 60 days
• Пищевая добавка OMega 3
  1000 mg: 1 table per day in the morning during 60 days
• Пищевая добавка vitamin B9
  5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
• Пищевая добавка Vitamin B12
  250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
• Пищевая добавка Leucin-rich whey
  In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
• Другое ICOPE Step 1
  usual ICOPE Step 1

Первичные конечные точки

• Estimation of the effect size of the intervention on the cognitive function [Срок оценки: 60 days]
• Estimation of the effect size of the intervention on the muscle function [Срок оценки: 60 days]
• Estimation of the effect size of the intervention on the immune function [Срок оценки: 60 days]

Критерии участия

Критерии включения

• Independent-living (ADL ≥5/6)
• Men and women
• Mobility impairment (5 Chair-rise test >12 seconds)
• Sedentarism (spend six or more hours per day sitting or lying down)
• Positive screening for cognitive impairment according to the ICOPE screening tool with MMSE \[25-28\]
• BMI ≥25 kg/m2

Критерии исключения

• Unintentional weight loss (≥10%) in past 6 months
• Dementia
• Life-threatening illnesses, with a life expectancy (judged by the investigating doctor) of less than 1 year
• Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina or any other contraindication to physical activity (as determined by a physician) or comorbid disease that would impair ability to participate in the ICOPE intense intervention such as renal failure on hemodialysis, severe psychiatric disorder (depressive participant will not be excluded)
• Organizational inability (three-time per week during the 60 days)
• Living in a Nursing-Home
• Under legal protection measure (guardianship, curatorship, safeguard of justice

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

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Cité de la santé - Hopital La Grave — Toulouse

Идентификаторы

NCT: NCT07048860 · RC31/24/0519 · 2025-A00891-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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