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

• Sponsor: Franklin Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT04499560
• Collaborator: Young Living Essential Oils (Other)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 32.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep; Stress; Health, Subjective; Inflammation; Cognitive Symptom	Dietary Supplement: Supplement Drink	N/A

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
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effects of a Nutrition Supplement on Health Related Quality of Life
• Actual Study Start Date: Aug 3, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.)

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Franklin School of Integrative Health Sciences	Franklin	Tennessee	United States	37067

Sponsors and Collaborators

• Franklin Health Research
• Young Living Essential Oils

Investigators

• Principal Investigator: Jessie Hawkins, PhD, Franklin Health Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessie Hawkins, PhD, Research Director, Franklin Health Research
• ClinicalTrials.gov Identifier: NCT04499560
• Other Study ID Numbers: 20-7-1100
• First Posted: Aug 5, 2020
• Last Update Posted: Feb 26, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jessie Hawkins, PhD, Research Director, Franklin Health Research: immune health; prevention; phytonutrients; superfoods; antioxidant; essential oils
• Additional relevant MeSH terms: Neurobehavioral Manifestations; Inflammation

Study Results

No Results Posted as of Feb 26, 2021