NCT00328913

CompletedPhase 2

The Effect of 5-Hydroxytryptophan (5-HTP) on Satiety

TNO Source

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Other study identifiers

Sponsor study identifier

P6880

Study Type

interventional

Reported enrollment (type unavailable)

24

Locations

1 country

Sites

1

Timeline

Study Start

March 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2006

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The aim of the study is to show evidence of the efficacy of 5-HTP to induce satiety and to reduce food intake (confirmatory study). The primary objective of the present study is to determine:

the effectiveness of a 5-HTP preparation on satiety markers (before intake of a meal and during the day) The secondary objectives of the present study are to determine the effectiveness of a 5-HTP preparation on:
food consumption (amount and composition) during a free meal (dinner);
wellness after one week supplementation;
the intermeal interval;
body weight and waist-hip ratio (WHR).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 24 participants
Study completion date: July 2006
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 22, 2006
Actual (reported)
First Posted
May 24, 2006
Actual (reported)
Study Completion
July 2006
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: January 9, 2007
Status Verified: January 2007
Last Update Submitted: January 8, 2007

Conditions

Obesity

Keywords

satietyfood intakemoodwellnessweight management

Outcome Measures

Primary Outcomes (1)

satiety scores (visual analog scores)

Secondary Outcomes (4)

food intake
wellness
intermeal interval
body weight and waist-hip ratio

Interventions

5-hydroxytryptophan (food supplement)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy as assessed by:
The TNO health and lifestyle questionnaire

Sponsors & Collaborators

Laboratoire Oenobiol
Type not reportedcollaborator
TNO
Otherlead

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3704HE, Netherlands

MeSH Terms

Conditions

Obesity

Interventions

5-HydroxytryptophanDietary Supplements

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TryptophanAmino Acids, AromaticAmino Acids, Cyclic

Study Officials

Wilrike Pasman, PhD
TNO
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

March 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2006

Date type not reported

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Physical examination

Females aged 18 through 65 years on Day 01 of the study

Body mass index (BMI) 25 - 32 kg/m2 (if enough subjects are available, subjects with a BMI 25 - 30 kg/m2 will be included first).

Regular and normal Dutch eating habits (consuming mostly three main meals including breakfast) as assessed by the questionnaire on health and lifestyle

Non-restraint eaters, defined by a score of \< 3.4 on the Dutch Eating Behaviour Questionnaire

Using oral contraceptives for \> 3 months (only fixed phase)

Voluntary participation

Having given written informed consent

Willing to comply with the study procedures

Willing to agree to the use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years

Willing to agree to the disclosure of the financial benefit of participation in the study to the authorities concerned

You may not qualify if:

Subjects with one or more of the following characteristics will be excluded from participation:
Participation in any clinical trial including blood sampling and/or administration of pharmaceutical or nutritional substances up to 90 days before Day 01 of this study
Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including blood sampling and/or oral, intravenous, or inhalatory administration of pharmaceutical or nutritional substances
Mental status that is incompatible with the proper conduct of the study (including depression)
Having a history of medical or surgical events that may significantly affect the study outcome, including metabolic or endocrine disease, especially diabetes type I or II; cardiovascular diseases (including hypertension); gastrointestinal diseases, including events that affect nutrient uptake or appetite; or using medication that may interfere with 5-HTP (antidepressants \[selective serotonin reuptake inhibitors {SSRIs}, monoamine oxidase inhibitors {MAOIs}\], migraine medication, or some hypertension medication).
Smoking
Having a history of drug abuse
Claustrophobia
Alcohol consumption \> 21 units (glasses)/week
Not willing to stop use of supplements of minerals or vitamins from screening onwards
Reported food allergy or sensitivity (wheat, milk, eggs, nuts, etc.)
Reported unexplained weight loss or weight gain of \> 2 kg in the month prior to pre-study screening
Practicing sports \> 10 hours a week
Reported slimming or medically prescribed diet
Reported vegan, vegetarian, or macrobiotic lifestyle
+6 more criteria

Contact the study team to confirm eligibility.

Amino Acids

Amino Acids, Peptides, and Proteins

Food

Diet, Food, and Nutrition

Physiological Phenomena

Food and Beverages

This date has not been verified as actual or estimated.

Last Updated

January 9, 2007

Record last verified: 2007-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00328913
Data provider: ClinicalTrials.gov
Source updated: 2007-01-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:36 UTC

Locations

NL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations