Effects of Daily Supplementation of 5-HTP on Body Composition

NCT05216406 | Completed Results

• 1 other identifier: 102
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Composition

Keywords

Body Composition; 5-HTP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dietary Habits

  8 weeks

• Blood Pressure

  8 weeks

• Resting Heart Rate

  8 weeks

Study Arms (2)

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.

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.

Other: Placebo

Interventions

5-HTP DIETARY_SUPPLEMENT

CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.

Also known as: CLEANMOOD™

5-HTP

Placebo OTHER

Maltodextrin capsule

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Physically inactive
• Regularly used sleep aids of any kind
• Currently taking selective serotonin reuptake inhibitors (SSRIs) and/or 5-HTP containing supplements.

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

IHP

Boca Raton, Florida, 33432, United States

Location

Related Publications (3)

• 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.

  PMID: 33375373 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.

  PMID: 31258047 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.

  PMID: 1722953 BACKGROUND

MeSH Terms

Interventions

5-Hydroxytryptophan

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Jose Antonio
• Organization: Nova Southeastern University

Jose.Antonio@nova.edu

(954) 262-8140

Study Officials

• Jose Antonio, PhD

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All subjects and investigators were blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal Investigator

Model Details: This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 31, 2022
• Study Start: January 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 15, 2021
• Last Updated: February 12, 2025
• Results First Posted: February 20, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)