Body Composition
Conditions
Keywords
Body Composition, 5-HTP
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.
Interventions
DIETARY_SUPPLEMENT5-HTP
CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.
OTHERPlacebo
Maltodextrin capsule
Sponsors
Nova Southeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
All subjects and investigators were blinded.
Intervention model description
This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient. | 31 |
| Control The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.
Placebo: Maltodextrin capsule | 17 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 9 |
Baseline characteristics
| Characteristic | 5-HTP | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 17 Participants | 48 Participants |
| Blood Pressure Diastolic | 72 mmHg STANDARD_DEVIATION 10 | 70 mmHg STANDARD_DEVIATION 6 | 71 mmHg STANDARD_DEVIATION 4 |
| Blood Pressure Systolic | 118 mmHg STANDARD_DEVIATION 14 | 117 mmHg STANDARD_DEVIATION 13 | 117.5 mmHg STANDARD_DEVIATION 13.5 |
| Body Composition Body Mass | 72.9 Kilograms STANDARD_DEVIATION 13.4 | 69.1 Kilograms STANDARD_DEVIATION 11.9 | 71 Kilograms STANDARD_DEVIATION 12 |
| Body Composition Fat Mass | 15.3 Kilograms STANDARD_DEVIATION 6 | 12.4 Kilograms STANDARD_DEVIATION 4.4 | 13.9 Kilograms STANDARD_DEVIATION 5.2 |
| Body Composition Lean Body Mass | 57.5 Kilograms STANDARD_DEVIATION 13.9 | 57.5 Kilograms STANDARD_DEVIATION 13.7 | 57.5 Kilograms STANDARD_DEVIATION 13.8 |
| Dietary Intake Carbohydrate | 836 Kilocalories STANDARD_DEVIATION 452 | 840 Kilocalories STANDARD_DEVIATION 424 | 838 Kilocalories STANDARD_DEVIATION 438 |
| Dietary Intake Fat | 603 Kilocalories STANDARD_DEVIATION 288 | 630 Kilocalories STANDARD_DEVIATION 234 | 616.5 Kilocalories STANDARD_DEVIATION 261 |
| Dietary Intake Protein | 468 Kilocalories STANDARD_DEVIATION 172 | 548 Kilocalories STANDARD_DEVIATION 224 | 508 Kilocalories STANDARD_DEVIATION 198 |
| Dietary Intake Total Intake | 1906 Kilocalories STANDARD_DEVIATION 683 | 2022 Kilocalories STANDARD_DEVIATION 765 | 1964 Kilocalories STANDARD_DEVIATION 720 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Resting Heart Rate | 69 Beats Per Minute (BPM) STANDARD_DEVIATION 12 | 70 Beats Per Minute (BPM) STANDARD_DEVIATION 13 | 69.5 Beats Per Minute (BPM) STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 19 Participants | 11 Participants | 30 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 17 |
| other Total, other adverse events | 3 / 31 | 2 / 17 |
| serious Total, serious adverse events | 0 / 31 | 0 / 17 |
Outcome results
Primary
Body Composition
The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270).
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-HTP | Body Composition | Fat Mass | 14.6 Kilograms | Standard Deviation 5.7 |
| 5-HTP | Body Composition | Lean Body Mass | 58.4 Kilograms | Standard Deviation 13.9 |
| 5-HTP | Body Composition | Body Mass | 73 Kilograms | Standard Deviation 12.8 |
| Control | Body Composition | Fat Mass | 12.6 Kilograms | Standard Deviation 4.4 |
| Control | Body Composition | Lean Body Mass | 57.7 Kilograms | Standard Deviation 13.6 |
| Control | Body Composition | Body Mass | 70.2 Kilograms | Standard Deviation 12.4 |
Secondary
Blood Pressure
Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-HTP | Blood Pressure | Systolic | 119 mmHG | Standard Deviation 14 |
| 5-HTP | Blood Pressure | Diastolic | 70 mmHG | Standard Deviation 7 |
| Control | Blood Pressure | Systolic | 117 mmHG | Standard Deviation 16 |
| Control | Blood Pressure | Diastolic | 67 mmHG | Standard Deviation 11 |
Secondary
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5-HTP | Dietary Habits | Carbohydrate | 796 calories | Standard Deviation 364 |
| 5-HTP | Dietary Habits | Protein | 440 calories | Standard Deviation 140 |
| 5-HTP | Dietary Habits | Total Intake | 1810 calories | Standard Deviation 650 |
| 5-HTP | Dietary Habits | Fat | 576 calories | Standard Deviation 198 |
| Control | Dietary Habits | Fat | 684 calories | Standard Deviation 387 |
| Control | Dietary Habits | Carbohydrate | 816 calories | Standard Deviation 392 |
| Control | Dietary Habits | Total Intake | 1966 calories | Standard Deviation 826 |
| Control | Dietary Habits | Protein | 464 calories | Standard Deviation 168 |
Secondary
Resting Heart Rate
Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5-HTP | Resting Heart Rate | 70 BPM | Standard Deviation 10 |
| Control | Resting Heart Rate | 65 BPM | Standard Deviation 7 |