The Effects of a Nutrition Supplement on Health Related Quality of Life

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

Detailed Description
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After being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. Those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be assessed at baseline, on day 30 and on day 60.

Official Title
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The Effects of a Nutrition Supplement on Health Related Quality of Life

Conditions
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Sleep, Stress, Health, Subjective, Inflammation, Cognitive Symptom

Intervention / Treatment
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* Dietary Supplement: Supplement Drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: otherwise healthy adults living in the US is practicing adequate contraception or is abstaining from all activities which could result in pregnancy understands and agrees to comply with study procedures provides informed consent Exclusion Criteria: smoker pregnant or may become pregnant currently breastfeeding currently taking antioxidant supplements underlying chronic health conditions COVID-19 diagnosis demonstrated inability to comply with study procedures history of allergy to citrus or berry fruits has participated in an interventional clinical study within 31 days prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants consume 2 ounces of the supplement each morning for 60 days. | Dietary Supplement: Supplement Drink<br>* Superfoods based nutritional supplement<br>|
| No Intervention: Control<br>Participants do not make any changes to their health related routines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60 | The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items. | Baseline and day 60 | 
| Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60 | The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items. | Baseline and day 60 | 
| Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60 | The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items. | Baseline and day 60 | 
| Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60. | The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.) | Day 60 | 
| Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60 | The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items. | Baseline and Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune health, prevention, phytonutrients, superfoods, antioxidant, essential oils