A Randomized Double Blind, Placebo Controlled Clinical Study Evaluating the Efficacy and Safety of Magnesium Supplementation on Relaxation in Adults

Обзор

The study will assess the efficacy of magnesium supplementation for improvement of body and mind relaxation (through stress levels), and sleep score compared to placebo, assessed by validated questionnaires. Participants will be asked to take the supplement every day for 12 weeks and will complete monthly check-ins and questionnaires. Participants will monitor adverse events in a journal.

Вмешательства

• Пищевая добавка Placebo
  Placebo
• Пищевая добавка Dietary Supplement with actives
  Dietary Supplement containing magnesium

Первичные конечные точки

• Changes in PSS scores [Срок оценки: From start of study until end of the study at week 12]

Вторичные конечные точки (1)

• Changes in Relaxation State Questionnaire scores [Срок оценки: From start of study until end of the study at week 12]

Критерии участия

Критерии включения

• Healthy participants (women + men)
• Will maintain regular diet and exercise habits
• Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.

Критерии исключения

• Neurological or psychiatric disorders
• Pregnant or breastfeeding
• Known allergies to magnesium-containing products
• Taking a medication known to interact with magnesium, or taking loop diuretics, cyclosporine, digoxin, amphotericin.
• No concurrent magnesium supplementation
• Substance or alcohol abuse
• Currently use, or have used within appropriate washout period, any prescription, over the counter medication, or supplements with primary CNS activity such as Antidepressants,mood stabilizer and anxiolytics, Sedatives and Stimulants
• Anticholinergic or cholinergic medications
• Anti-inflammatory and analgesic medication (except for PRN use)
• Anti-allergy medication (except for non-sedating antihistamines)
• Blood thinners
• Other prescribed medications that may affect cognition, stress, or mood
• Body mass index (BMI) greater than 40 kg/m2 ,
• Individuals on angiotensin converting enzyme inhibitors for blood pressure control, other magnesium-retaining drugs, or potassium-sparing drugs
• History of reaction to the category of product tested
• Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• Subjects with any invasive medical procedures during the study.
• Participants who are unreliable or unlikely to be available for the duration of the study.
• No employees of PCR or the sponsor (e.g OLLY PBC, Unilever, or the H\&W Collective)

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

Поддерживающая терапия

Центры проведения

США · 1 центр

• Princeton Consumer Research — St. Petersburg

Идентификаторы

NCT: NCT07029607 · OLLCLI2F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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