Quality of LifeNCT05037877
An Exploratory Investigation of Dietary Supplementation and Its Effect
A study testing HUM supplement in people with Quality of Life, run by HUM Nutrition, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced. Read more about this study
- Who is it for?
- Ages 38 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- HUM supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 31 Oct 2021
- 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 38 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Willing to maintain the current dietary pattern, activity level, and stable body weight for the duration of the study
- Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- Willing and able to provide written informed consent
Who cannot join
- Allergies to any test product ingredients
- Any other severe chronic disease
- Pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
- Participating in an investigational health product research study
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced.
Read the detailed description
This will be a 2-arm randomized, double-blinded, placebo-controlled study.
- Conditions
- Quality of Life
- Being tested
- HUM supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUM supplementDietary supplement
HUM supplement - 1 capsule per day
PlaceboDietary supplement
Placebo supplement - 1 capsule per day
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | HUM supplement - 1 capsule per day Receives: Dietary Supplement: HUM supplement |
| Placebo group | Placebo comparator | Placebo supplement - 1 capsule per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life improvements [Time Frame: Baseline to 8 weeks)
Survey-based assessment (0-5 scale) with higher scores representing an improved outcome
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start31 Aug 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a 2-arm randomized, double-blinded, placebo-controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUM Nutrition, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Susanne Mitschke, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037877
- Sponsor's protocol ID
- 20220HUM
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of Dietary Supplementation and Its Effect
- ClinicalTrials.gov ID
- NCT05037877
- Acronym / sponsor ID
- 20220HUM
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- HUM Nutrition, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 8 Sep 2021 (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 primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced.
Detailed description
This will be a 2-arm randomized, double-blinded, placebo-controlled study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a 2-arm randomized, double-blinded, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: HUM supplementHUM supplement - 1 capsule per day |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplement - 1 capsule per day |
Who may qualify
- Ages
- 38 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Willing to maintain the current dietary pattern, activity level, and stable body weight for the duration of the study
- Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- Willing and able to provide written informed consent
Key exclusion criteria (4 listed)
- Allergies to any test product ingredients
- Any other severe chronic disease
- Pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
- Participating in an investigational health product research study
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 |
|---|---|---|
| HUM supplementHUM supplement - 1 capsule per day | Dietary supplement | Intervention group |
| PlaceboPlacebo supplement - 1 capsule per day | Dietary supplement | Placebo group |
Primary outcome
Quality of life improvements [Time Frame: Baseline to 8 weeks)
Time frame: 8 week
Survey-based assessment (0-5 scale) with higher scores representing an improved outcome
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 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Susanne Mitschke 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 HUM supplement in people with Quality of Life, run by HUM Nutrition, Inc. 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 4 inclusion and 4 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 Apr 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. Some participants in this study may receive a placebo. 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?
Quality of life improvements [Time Frame: Baseline to 8 weeks) (time frame: 8 week). 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 Apr 2022.