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

F

Franklin Health Research

Status

Completed

Conditions

Inflammation
Cognitive Symptom
Health, Subjective
Sleep
Stress

Treatments

Dietary Supplement: Supplement Drink

Study type

Interventional

Funder types

Other

Identifiers

NCT04499560
20-7-1100

Details and patient eligibility

About

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

Full 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.

Enrollment

160 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Intervention
Experimental group
Description:
Participants consume 2 ounces of the supplement each morning for 60 days.
Treatment:
Dietary Supplement: Supplement Drink
Control
No Intervention group
Description:
Participants do not make any changes to their health related routines

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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