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

NCT04499560 | Completed

• 1 other identifier: 20-7-1100
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Stress; Health, Subjective; Inflammation; Cognitive Symptom

Keywords

immune health; prevention; phytonutrients; superfoods; antioxidant; essential oils

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Supplement Drink

Control

NO INTERVENTION

Participants do not make any changes to their health related routines

Interventions

Supplement Drink DIETARY_SUPPLEMENT

Superfoods based nutritional supplement

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead
• Young Living Essential Oils: collaborator

Study Sites (1)

Franklin School of Integrative Health Sciences

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Inflammation; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Jessie Hawkins, PhD

  Nutraceuticals Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 5, 2020
• Study Start: August 3, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)