Effects of Daily Supplementation of 5-HTP on Body Composition

Study Overview
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Brief Summary
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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.

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

Conditions
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Body Composition

Intervention / Treatment
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* Dietary Supplement: 5-HTP
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 
| 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 | 
| Resting Heart Rate | Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Composition, 5-HTP