Effects of Daily Supplementation of 5-HTP on Body Composition

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.

Study Overview

• Status: Completed
• Conditions: Body Composition
• Intervention / Treatment: Dietary supplement: 5-HTP; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33432
      • IHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 5-HTP; CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.; Other Names: CLEANMOOD™
Placebo Comparator: Control; The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.	Other: Placebo; Maltodextrin capsule; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Resting Heart Rate	Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff.	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.	8 weeks

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Investigators: Principal Investigator: Jose Antonio, PhD, Nova Southeastern University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Body Composition; 5-HTP
• Other Study ID Numbers: 102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No