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

Primary Purpose

Sleep, Stress, Health, Subjective

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supplement Drink
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep focused on measuring immune health, prevention, phytonutrients, superfoods, antioxidant, essential oils

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Franklin School of Integrative Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Participants consume 2 ounces of the supplement each morning for 60 days.

Participants do not make any changes to their health related routines

Outcomes

Primary Outcome Measures

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.
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.
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.
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.)
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.

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
February 25, 2021
Sponsor
Franklin Health Research
Collaborators
Young Living Essential Oils
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1. Study Identification

Unique Protocol Identification Number
NCT04499560
Brief Title
The Effects of a Nutrition Supplement on Health Related Quality of Life
Official Title
The Effects of a Nutrition Supplement on Health Related Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Franklin Health Research
Collaborators
Young Living Essential Oils

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Stress, Health, Subjective, Inflammation, Cognitive Symptom
Keywords
immune health, prevention, phytonutrients, superfoods, antioxidant, essential oils

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants consume 2 ounces of the supplement each morning for 60 days.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants do not make any changes to their health related routines
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplement Drink
Intervention Description
Superfoods based nutritional supplement
Primary Outcome Measure Information:
Title
Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60
Description
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.
Time Frame
Baseline and day 60
Title
Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60
Description
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.
Time Frame
Baseline and day 60
Title
Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60
Description
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.
Time Frame
Baseline and day 60
Title
Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.
Description
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.)
Time Frame
Day 60
Title
Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
Description
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.
Time Frame
Baseline and Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie Hawkins, PhD
Organizational Affiliation
Franklin Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franklin School of Integrative Health Sciences
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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