AnxietyNCT05523115
An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
A study testing Heights Smart Supplement in people with Anxiety and Stress, run by Heights at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress, Memory Deficits
- What is being tested?
- Heights Smart Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anxiety, Stress, Memory Deficits, Cortisol Overproduction
- Being tested
- Heights Smart Supplement
- Keywords
- memory, stress, anxiety, mood, focus
- Medical subject headings
- Anxiety Disorders, Memory Disorders, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heights Smart SupplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Heights Smart Supplement | Experimental | 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. Receives: Dietary Supplement: Heights Smart Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Measures of C-reactive protein
Biomarkers measured by a third party lab through blood samples submitted by participants.
Measured: 12 weeks
Changes in Measures of cortisol
Biomarkers measured by a third party lab through blood samples submitted by participants.
Measured: 12 weeks
Changes in Sleep Quality as measured via Fitness trackers and Questionnaires
Measurements taken via existing smart watches and report that data on the questionnaires.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Jun 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heights
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Christopher Hill, PhD, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523115
- Sponsor's protocol ID
- 20250
- Status last verified
- Nov 2022
- First submitted
- 26 Aug 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
- ClinicalTrials.gov ID
- NCT05523115
- Acronym / sponsor ID
- 20250
- Conditions
- Anxiety, Stress, Memory Deficits, Cortisol Overproduction
- Keywords
- memory, stress, anxiety, mood, focus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- HeightsIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heights Smart Supplement | Experimental | Dietary Supplement: Heights Smart SupplementParticipants will take the supplement over a 12 week period. There will be both biomarker outcomes and subjective outcomes reported by the participants via questionnaires. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heights Smart SupplementThe 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 | Dietary supplement | Heights Smart Supplement |
Primary outcome
Changes in Measures of C-reactive protein
Time frame: 12 weeks
Biomarkers measured by a third party lab through blood samples submitted by participants.
Changes in Measures of cortisol
Time frame: 12 weeks
Biomarkers measured by a third party lab through blood samples submitted by participants.
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.
1 secondary outcome
examine the subjective experiences of participants taking the Heights Smart Supplement.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Hill, PhD principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heights Smart Supplement in people with Anxiety and Stress, run by Heights at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Measures of C-reactive protein (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.