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OpenTrials
Completed

NCT Number: NCT04499560

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

The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

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Key information

Conditions

Sleep Cognitive Symptom Health, Subjective Inflammation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franklin School of Integrative Health Sciences

Franklin, Tennessee, 37067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplement Drink

Dietary Supplement

Superfoods based nutritional supplement

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.)

  5. 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.

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Collaborators

  • Young Living Essential Oils

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2020
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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