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

Not Applicable

Completed

• Conditions: Sleep; Cognitive Symptom; Stress; Health, Subjective; Inflammation
• Interventions: Dietary Supplement: Supplement Drink

• Registration Number: NCT04499560
• Lead Sponsor: Franklin Health Research

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 Timeline

• Study First Submitted: 2020-07-30
• Study Start: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Supplement Drink	Participants consume 2 ounces of the supplement each morning for 60 days.

Primary Outcome Measures

Name	Time	Method
Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60	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	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	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	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.	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.)

Trial Locations

Locations (1)

Franklin School of Integrative Health Sciences; 🇺🇸 Franklin, Tennessee, United States