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

Nutraceuticals Research Institute160 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

160

Conditions

Sleep Stress Health, Subjective Inflammation Cognitive Symptom

Interventions

Supplement DrinkDIETARY_SUPPLEMENT

Superfoods based nutritional supplement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Franklin School of Integrative Health Sciences

Franklin, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.)

Time frame: 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.

Time frame: Baseline and Day 60

Data from ClinicalTrials.gov

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