An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits

Anxiety Clinical Trial

Official title:

An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523115
• Other study ID #: 20250
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2022
• Source: Heights
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Anxiety
• Cortisol Overproduction
• Memory Deficits
• Memory Disorders
• Stress

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Heights	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Measures of C-reactive protein	Biomarkers measured by a third party lab through blood samples submitted by participants.	12 weeks
Primary	Changes in Measures of cortisol	Biomarkers measured by a third party lab through blood samples submitted by participants.	12 weeks
Primary	Changes in Sleep Quality as measured via Fitness trackers and Questionnaires	Measurements taken via existing smart watches and report that data on the questionnaires.	12 weeks
Secondary	examine the subjective experiences of participants taking the Heights Smart Supplement.	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