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

February 25, 2021 updated by: Jessie Hawkins, PhD, Franklin Health Research
The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Franklin School of Integrative Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60
Time Frame: 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.
Baseline and day 60
Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60
Time Frame: 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.
Baseline and day 60
Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60
Time Frame: 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.
Baseline and day 60
Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.
Time Frame: 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
Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
Time Frame: 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.
Baseline and Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin Health Research

Collaborators

Young Living Essential Oils

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (ACTUAL)

August 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-7-1100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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