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Completed

NCT Number: NCT05216406

Effects of Daily Supplementation of 5-HTP on Body Composition

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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Key information

Conditions

Body Composition

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IHP

Boca Raton, Florida, 33432, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5-HTP

Dietary Supplement

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

Other names: CLEANMOOD™

Placebo

Other

Maltodextrin capsule

Other names: Control

Primary outcomes

  1. Body Composition

    Time frame: 8 weeks

    The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270).

Secondary outcomes

  1. Dietary Habits

    Time frame: 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.

  2. Blood Pressure

    Time frame: 8 weeks

    Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff.

  3. Resting Heart Rate

    Time frame: 8 weeks

    Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff.

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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