Effects of Daily Supplementation of 5-HTP on Body Composition

Body Composition Clinical Trial

Official title:

Effects of Daily Supplementation of 5-HTP on Body Composition, a Randomized Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05216406
• Other study ID #: 102
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 15, 2021

Study information

• Verified date: August 2023
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 15, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Physically inactive

• Regularly used sleep aids of any kind

• Currently taking selective serotonin reuptake inhibitors (SSRIs) and/or 5-HTP containing supplements.

Related Conditions & MeSH terms

• Body Composition

Intervention

Dietary Supplement:
• 5-HTP
CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.

Other:
• Placebo
Maltodextrin capsule

Locations

Country	Name	City	State
United States	IHP	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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.	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.	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.	8 weeks