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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499560
• Other study ID #: 20-7-1100
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Symptom
• Health, Subjective
• Inflammation
• Neurobehavioral Manifestations
• Sleep
• Stress

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