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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04499560
Other study ID # 20-7-1100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2020
Est. completion date December 31, 2020

Study information

Verified date February 2021
Source Franklin School of Integrative Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Supplement Drink
Superfoods based nutritional supplement

Locations

Country Name City State
United States Franklin School of Integrative Health Sciences Franklin Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Franklin School of Integrative Health Sciences Young Living Essential Oils

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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