Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain

Обзор

The goal of this study is to use pain-specific urine biomarkers to evaluate how daily nutritional supplementation with biomarker guided formulas effect, quality of life and urinary biomarker scores in chronic pain patients. Assessing the effect of biomarker guided supplementation on pain specific biomarkers through changes in urinary biomarker scores may solidify the necessity for identifying deficiencies to create an individualized treatment plan for pain patients. This study aims to evaluate the effect of biomarker-guided supplementation on the three categories of urinary biomarkers using targeted ingredients specifically designed for oxidative stress, inflammation, and nerve health. This study provides subjects with one of three nutritional supplement formulas based on their specific urinary biomarker test results and assesses changes in their urinary biomarker levels and their quality of life as it relates to their pain over a 3-month period.

Вмешательства

• Пищевая добавка Inflammation Support Formula
  Turmeric Extract (400mg), Bioperine (Black pepper, 10mg), Ashwagandha (500mg), and Olive Leaf Extract (250mg).
• Пищевая добавка Nerve Health Formula
  Hydroxocobalamin (Vitamin B12, 1000mcg), Pyridoxal-5-Phosphate (Vitamin B6, 50mg), LMethylfolate (400mcg) and Trimethyl Glycine (Betaine, 750mg).
• Пищевая добавка Redox Support Formula
  N-Acetyl-L-Cysteine (500mg), CoQ10 (250mg), Acetyl-L-Carnitine (200mg), Alpha Lipoic Acid (200mg), Benfotiamine (300mg), Selenium (250mcg), Riboflavin (50mg), Zinc (15mg) and Copper (1.8mg).

Первичные конечные точки

• Quantitative urine biomarker levels. [Срок оценки: 1 and 3 months of supplementation.]
• Quality-of-life measures. [Срок оценки: 1 month of supplementation, 3 months and at 3 month follow up.]
• Quality-of-life measures. [Срок оценки: 1 month of supplementation, 3 months and at 3 month follow up.]

Вторичные конечные точки (5)

• Visual Analog Scale pain scores [Срок оценки: 1 month, 2 months, 3 months and at 3 month follow up.]
• Depression symptoms. [Срок оценки: 1 month, 2 months, 3 months and at 3 month follow up.]
• Anxiety symptoms. [Срок оценки: 1 month, 2 months, 3 months and at 3 month follow up.]
• Sleep quality score [Срок оценки: 1 month, 2 months, 3 months and at 3 month follow up.]
• Profile of Mood States [Срок оценки: 1 month, 2 months, 3 months and at 3 month follow up.]

Критерии участия

Критерии включения

• Previously submitted a urinary biomarker sample and agreed to be contacted for research.
• Be seeking treatment for chronic pain as defined as symptoms persisting for ≥ 3 months.
• Be able to take oral medication and/or be willing to adhere to the supplement regimen.

Критерии исключения

• Diagnosis of bacterial or viral infection during or 3 months prior to the study.
• Severe or untreated psychiatric disturbance and/or any psychiatric disorder that required hospitalization in the year prior to the screening visit.
• A history of cancer within 5 years prior to screening visit.
• Be pregnant or breast-feeding or have plans to become pregnant at any time during the study
• Participant has a known sensitivity or allergy to any of the ingredients in the study products.
• Participant has any dietary restriction that prevents the participant from consuming any of the ingredients in the study products.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Ethos Research and Development — Newport

Идентификаторы

NCT: NCT06247813 · 23-02-637-1557

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗