Body CompositionNCT05216406
Effects of Daily Supplementation of 5-HTP on Body Composition
A study testing 5-HTP in people with Body Composition, run by Nova Southeastern University at 1 site in United States.
Trial summary
The purpose of this investigation was to compare supplementation with 5-HTP to placebo on indices of body composition. A randomized trial compared a sample of 48 resistance-trained individuals taking either 100 mg of 5-hydroxytryptophan supplementation or a placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- What is being tested?
- 5-HTP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 15 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy or free of disease
- Minimum of 1 year of regular physical activity. Regular physical activity is defined by a minimum of 150 minutes of aerobic activity or performing muscle-strengthening exercises at least 2 days a week.
Who cannot join
- Physically inactive
- Regularly used sleep aids of any kind
- Currently taking selective serotonin reuptake inhibitors (SSRIs) and/or 5-HTP containing supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Daily Supplementation of 5-HTP on Body Composition, a Randomized Investigation
The purpose of this investigation was to compare supplementation with 5-HTP to placebo on indices of body composition. A randomized trial compared a sample of 48 resistance-trained individuals taking either 100 mg of 5-hydroxytryptophan supplementation or a placebo.
The investigators tested anthropometric measurements using a multi-frequency bioelectrical impedance device (InBody® 270). The primary outcome (i.e., changes in anthropometric measurements) was assessed at the first visit (pre-test-) and post-test (8 weeks). Secondary outcomes include resting heart rate, blood pressure, and dietary intake.
- Conditions
- Body Composition
- Being tested
- 5-HTP, Placebo
- Keywords
- Body Composition, 5-HTP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-HTPDietary supplement
Also called CLEANMOOD™
CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.
PlaceboOther
Also called Control
Maltodextrin capsule
| Study group | Role | What they receive |
|---|---|---|
| 5-HTP | Experimental | The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. Receives: Dietary Supplement: 5-HTP |
| Control | Placebo comparator | The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270).
Measured: 8 weeks
Secondary outcomes (3)
Dietary Habits
The mobile app MyFitnessPal was used to assess dietary intake. Subjects were instructed to log their food intake MyFitnessPal, for a minimum of 2-3 days per week during the entire study.
Measured: 8 weeks
Blood Pressure
Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff.
Measured: 8 weeks
Resting Heart Rate
Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies 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 study followed a placebo (PLA)-controlled, double-blind and parallel-group design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassandra Evans, Nova Southeastern University
- Investigators
- Jose Antonio, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216406
- Sponsor's protocol ID
- 102
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2021
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maffei ME. 5-Hydroxytryptophan (5-HTP): Natural Occurrence, Analysis, Biosynthesis, Biotechnology, Physiology and Toxicology. Int J Mol Sci. 2020 Dec 26;22(1):181. doi: 10.3390/ijms22010181.
PubMed 33375373Stamatakis E, Straker L, Hamer M, Gebel K. The 2018 Physical Activity Guidelines for Americans: What's New? Implications for Clinicians and the Public. J Orthop Sports Phys Ther. 2019 Jul;49(7):487-490. doi: 10.2519/jospt.2019.0609.
PubMed 31258047Cangiano C, Ceci F, Cairella M, Cascino A, Del Ben M, Laviano A, Muscaritoli M, Rossi-Fanelli F. Effects of 5-hydroxytryptophan on eating behavior and adherence to dietary prescriptions in obese adult subjects. Adv Exp Med Biol. 1991;294:591-3. doi: 10.1007/978-1-4684-5952-4_73. No abstract available.
PubMed 1722953
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Supplementation of 5-HTP on Body Composition, a Randomized Investigation
- ClinicalTrials.gov ID
- NCT05216406
- Acronym / sponsor ID
- 102
- Conditions
- Body Composition
- Keywords
- Body Composition, 5-HTP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation was to compare supplementation with 5-HTP to placebo on indices of body composition. A randomized trial compared a sample of 48 resistance-trained individuals taking either 100 mg of 5-hydroxytryptophan supplementation or a placebo.
The investigators tested anthropometric measurements using a multi-frequency bioelectrical impedance device (InBody® 270). The primary outcome (i.e., changes in anthropometric measurements) was assessed at the first visit (pre-test-) and post-test (8 weeks). Secondary outcomes include resting heart rate, blood pressure, and dietary intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| 5-HTP | Experimental | Dietary Supplement: 5-HTPThe dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. |
| Control | Placebo comparator | Other: PlaceboThe placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy or free of disease
- Minimum of 1 year of regular physical activity. Regular physical activity is defined by a minimum of 150 minutes of aerobic activity or performing muscle-strengthening exercises at least 2 days a week.
Key exclusion criteria (3 listed)
- Physically inactive
- Regularly used sleep aids of any kind
- Currently taking selective serotonin reuptake inhibitors (SSRIs) and/or 5-HTP containing supplements.
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 |
|---|---|---|
| 5-HTPAlso: CLEANMOOD™CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient. | Dietary supplement | 5-HTP |
| PlaceboAlso: ControlMaltodextrin capsule | Other | Control |
Primary outcome
Body Composition
Time frame: 8 weeks
The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270).
3 secondary outcomes
Dietary Habits
Time frame: 8 weeks
Blood Pressure
Time frame: 8 weeks
Resting Heart Rate
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33375373Maffei ME. 5-Hydroxytryptophan (5-HTP): Natural Occurrence, Analysis, Biosynthesis, Biotechnology, Physiology and Toxicology. Int J Mol Sci. 2020 Dec 26;22(1):181. doi: 10.3390/ijms22010181.
- Background: PubMed 31258047Stamatakis E, Straker L, Hamer M, Gebel K. The 2018 Physical Activity Guidelines for Americans: What's New? Implications for Clinicians and the Public. J Orthop Sports Phys Ther. 2019 Jul;49(7):487-490. doi: 10.2519/jospt.2019.0609.
- Background: PubMed 1722953Cangiano C, Ceci F, Cairella M, Cascino A, Del Ben M, Laviano A, Muscaritoli M, Rossi-Fanelli F. Effects of 5-hydroxytryptophan on eating behavior and adherence to dietary prescriptions in obese adult subjects. Adv Exp Med Biol. 1991;294:591-3. doi: 10.1007/978-1-4684-5952-4_73. No abstract available.
- 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.
Jose Antonio, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-HTP in people with Body Composition, run by Nova Southeastern University 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 2 inclusion and 3 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 12 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Composition (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05216406, which also lists 3 linked publications.
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 12 Feb 2025.