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Идёт набор NCT06425042

Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity

Без фазы С лечением Healthy Aging Lifestyle-related Condition Metabolic Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nicotinamide Riboside (NR), Placebo.
Кому может быть актуально
Состояния в реестре: Healthy Aging, Lifestyle-related Condition, Metabolic Diseases. Базовые параметры: 60 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чили
Следующий шаг
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Официальное название

Boosting the NAD+ Levels in Older Individuals Via Nicotinamide Riboside Supplementation and Exercise Training to Promote Metabolic Health

Обзор

The prevalence of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is mounting worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with diminished skeletal muscle mitochondrial function in humans. Nicotinamide adenosine dinucleotide (NAD) is a coenzyme that regulates mitochondrial function, therefore, plays an important role in energy metabolism. Importantly, it has been shown that high cellular NAD+ levels as well as a high NAD+/NADH ratio promote metabolic and mitochondrial health. In contrast, NAD+ bioavailability declines upon aging in humans as well as in animal models of metabolic disorders and type 2 diabetes. These findings fuel the notion of boosting the NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in aged individuals. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, boosts cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Interestingly, Recently, it has been suggested that metabolic conditions where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This metabolic condition could be achieved by exercise. However, studies combining NR and exercise are lacking, and that is why we will perform the present study.

Вмешательства

  • Пищевая добавка Nicotinamide Riboside (NR)
    Participants will ingest 1g/d of NR orally during 12 weeks in parallel to a exercise training program
  • Пищевая добавка Placebo
    Participants will ingest 1g/d of placebo orally during 12 weeks in parallel to a exercise training program

Первичные конечные точки

  • Skeletal muscle mitochondrial respiratory capacity [Срок оценки: 12 weeks]
Вторичные конечные точки (12)
  • Quantification of proteins that regulate oxidative metabolism [Срок оценки: 12 weeks]
  • Skeletal muscle mitochondrial content [Срок оценки: 12 weeks]
  • Maximal aerobic capacity [Срок оценки: 12 weeks]
  • Walking speed and distance [Срок оценки: 12 weeks]
  • Seating and standing transitions [Срок оценки: 12 weeks]
  • Exercise efficiency [Срок оценки: 12 weeks]
  • Intrahepatic liver fat content [Срок оценки: 12 weeks]
  • Body weight [Срок оценки: 12 weeks]
  • Total muscle mass [Срок оценки: 12 weeks]
  • Total fat mass [Срок оценки: 12 weeks]
  • Fat-free mass [Срок оценки: 12 weeks]
  • NAD+ levels [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Participants are able to provide signed and dated written informed consent prior to any study specific procedures
  • Aged ≥ 60 and ≤ 80 years
  • Body mass index (BMI) 25 - 35 kg/m2
  • Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
  • No signs of active cardiovascular disease, liver or kidney malfunction

Критерии исключения

  • Patients with congestive heart failure and and/or severe renal and or liver insufficiency
  • Uncontrolled hypertension
  • Any contra-indication for MRI scanning
  • Alcohol consumption of > 3 servings per day for man and >2 servings per day for woman
  • Smoking
  • Unstable body weight (weight gain or loss > 5kg in the last 3 months)
  • Engagement in structured exercise activities > 2 hours a week
  • Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results
  • Use of food supplements containing NR or Resveratrol (similar working mechanisms)

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Чили · 1 центр
  • Finis Terrae University — Santiago

Идентификаторы

NCT: NCT06425042 · 23-041

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗