Effects of Daily Supplementation of 5-HTP on Body Composition

Not Applicable

Completed

• Conditions: Body Composition
• Interventions: Other: Placebo; Dietary Supplement: 5-HTP

• Registration Number: NCT05216406
• Lead Sponsor: Nova Southeastern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-15
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Results First Submitted: 2022-07-11
• Results First Submitted QC: 2023-08-11
• Results First Posted: 2024-02-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.
5-HTP	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.

Primary Outcome Measures

Name	Time	Method
Body Composition	8 weeks	The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270).

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	8 weeks	Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff.
Resting Heart Rate	8 weeks	Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff.
Dietary Habits	8 weeks	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.

Trial Locations

Locations (1)

IHP; 🇺🇸 Boca Raton, Florida, United States