An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits

November 7, 2022 updated by: Heights
The Smart Supplement has 20 vitamins and minerals that have strong track records of demonstrating positive health effects, both physiologically and cognitively. This twelve-week trial will examine the effectiveness and efficacy of Heights Smart Supplement on both biomarkers and subjective experiences from participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

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

17 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In good general health with no major chronic conditions
  • Must experience one of the following issues: brain fog
  • OR issues with fatigue,
  • OR sleep issues,
  • OR trouble with focus and concentration,
  • OR lead a busy, stressful life.
  • Must have a fitness tracker that they use to track sleep behaviors.
  • May be on a vegan/vegetarian diet

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Anyone currently taking other supplements focused on brain health, or multi vitamins, including additional iron supplements
  • Anyone taking Thyroxine and Levothyroxine
  • Anyone taking antidepressants (such as Sertraline or SSRIs like fluoxetine)
  • Anyone on hormone replacement therapy
  • Anyone taking blood pressure medication (such as linosipril)
  • Anyone with a known allergic reaction
  • Any chronic conditions, including oncological and psychiatric disorders

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heights Smart Supplement
Participants will take the supplement over a 12 week period. There will be both biomarker outcomes and subjective outcomes reported by the participants via questionnaires.
Dietary supplement: Heights Smart Supplement

The ingredient list of the product includes the following:

Algae oil Blueberry Extract Methylcobalamin (Vitamin B12) Cholecalciferol (Vitamin D3) Ascorbic acid (Vitamin C) Retinol acetate (Vitamin A) Calcium L-methylfolate (Folic Acid) D-biotin Pyridoxine hydrochloride (Vitamin B6) Calcium pantothenate (Vitamin B5) Nicotinamide (Vitamin B3) Riboflavin (Vitamin B2) Thiamine hydrochloride (Vitamin B1) D-Alpha tocopheryl acetate (Vitamin E) Chromium picolinate Potassium iodide Iron Citrate Sodium selenite Zinc citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Measures of C-reactive protein
Time Frame: 12 weeks
Biomarkers measured by a third party lab through blood samples submitted by participants.
12 weeks
Changes in Measures of cortisol
Time Frame: 12 weeks
Biomarkers measured by a third party lab through blood samples submitted by participants.
12 weeks
Changes in Sleep Quality as measured via Fitness trackers and Questionnaires
Time Frame: 12 weeks
Measurements taken via existing smart watches and report that data on the questionnaires.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
examine the subjective experiences of participants taking the Heights Smart Supplement.
Time Frame: 12 weeks
The questionnaires for this study are specifically designed to understand changes in focus, anxiety embedded in mood & stress, memory, and overall well-being.
12 weeks

Collaborators and Investigators

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

Sponsor

Heights

Collaborators

Citruslabs

Investigators

  • Principal Investigator: Christopher Hill, PhD, Citruslabs

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)

June 15, 2022

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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