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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Placebo Comparator | The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-HTP | Dietary Supplement | CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Antonio, PhD | Nova Southeastern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IHP | Boca Raton | Florida | 33432 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33375373 | Background | 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. | |
| 31258047 | Background | Stamatakis 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5-HTP | 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. 5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient. |
| FG001 | Control | The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. Placebo: Maltodextrin capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5-HTP | 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. 5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Composition | The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270). | Posted | Mean | Standard Deviation | Kilograms | 8 weeks |
|
1 day
Self-report at the end of the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5-HTP | 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. 5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upset Stomach | Gastrointestinal disorders | Non-systematic Assessment | a disorder of digestive function characterized by discomfort or heartburn or nausea. dyspepsia, indigestion, stomach upset |
The primary limitation of this study was the lack of control for exercise. Although subjects were instructed to maintain the same training habits, it is certainly possible that training changed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jose Antonio | Nova Southeastern University | (954) 262-8140 | Jose.Antonio@nova.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2022 | Jul 11, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 31, 2020 | Dec 7, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006916 | 5-Hydroxytryptophan |
| ID | Term |
|---|---|
| D014364 | Tryptophan |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.
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All subjects and investigators were blinded.
| Placebo | Other | Maltodextrin capsule |
|
|
Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff.
| 8 weeks |
| Resting Heart Rate | Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff. | 8 weeks |
| 1722953 | Background | Cangiano 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. |
| Control |
The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. Placebo: Maltodextrin capsule |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Composition | Mean | Standard Deviation | Kilograms |
|
| Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Resting Heart Rate | Mean | Standard Deviation | Beats Per Minute (BPM) |
|
| Dietary Intake | Mean | Standard Deviation | Kilocalories |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | calories | 8 weeks |
|
|
|
| Secondary | Blood Pressure | Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff. | Posted | Mean | Standard Deviation | mmHG | 8 weeks |
|
|
|
| Secondary | Resting Heart Rate | Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff. | Posted | Mean | Standard Deviation | BPM | 8 weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 3 |
| 31 |
| EG001 | Control | The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks. Placebo: Maltodextrin capsule | 0 | 17 | 0 | 17 | 2 | 17 |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| Carbohydrate |
|
| Protein |
|