The Effects of a Nutrition Supplement on Health Related Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
Time Frame: Baseline and 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.
Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60
Time Frame: Baseline and 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.
Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60
Time Frame: Baseline and 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.
Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60
Time Frame: Baseline and 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.
Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.
Time Frame: 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.)
Secondary Outcomes
No secondary outcomes reported
Investigators
Jessie Hawkins, PhD
Research Director
Franklin Health Research