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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: 5-hydroxytryptophan (food supplement)	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Effectiveness of 5-Hydroxytryptophan on Satiety in a Randomised, Placebo Controlled, Time Blinded Study, in Overweight Women
Study Start Date :	March 2006
Study Completion Date :	July 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. satiety scores (visual analog scores)

Secondary Outcome Measures :

1. food intake
2. wellness
3. intermeal interval
4. body weight and waist-hip ratio

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Healthy as assessed by:

   • The TNO health and lifestyle questionnaire
   • Physical examination
2. Females aged 18 through 65 years on Day 01 of the study
3. 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).
4. Regular and normal Dutch eating habits (consuming mostly three main meals including breakfast) as assessed by the questionnaire on health and lifestyle
5. Non-restraint eaters, defined by a score of < 3.4 on the Dutch Eating Behaviour Questionnaire
6. Using oral contraceptives for > 3 months (only fixed phase)
7. Voluntary participation
8. Having given written informed consent
9. Willing to comply with the study procedures
10. 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
11. Willing to agree to the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

Subjects with one or more of the following characteristics will be excluded from participation:

1. 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
2. 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
3. Mental status that is incompatible with the proper conduct of the study (including depression)
4. 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).
5. Smoking
6. Having a history of drug abuse
7. Claustrophobia
8. Alcohol consumption > 21 units (glasses)/week
9. Not willing to stop use of supplements of minerals or vitamins from screening onwards
10. Reported food allergy or sensitivity (wheat, milk, eggs, nuts, etc.)
11. Reported unexplained weight loss or weight gain of > 2 kg in the month prior to pre-study screening
12. Practicing sports > 10 hours a week
13. Reported slimming or medically prescribed diet
14. Reported vegan, vegetarian, or macrobiotic lifestyle
15. Pregnant or lactating or wishing to become pregnant in the period of the study
16. Recent blood or plasma donation (< 1 month prior to Day 01 of the study)
17. Not willing to give up blood/plasma donation during the study
18. Personnel of TNO Quality of Life (located in Zeist), their partners and their first and second degree relatives
19. Not having a general practitioner
20. Not willing to accept information-transfer concerning participation in the study; or information regarding health, like laboratory results, findings at anamnesis or physical examination, and eventual adverse events to and from general practitioner.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
TNO Quality of Life
Zeist, Utrecht, Netherlands, 3704HE

Sponsors and Collaborators

TNO

Laboratoire Oenobiol

Investigators

Principal Investigator:	Wilrike Pasman, PhD	TNO

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00328913 History of Changes
Other Study ID Numbers:	P6880
First Posted:	May 24, 2006
Last Update Posted:	January 9, 2007
Last Verified:	January 2007

Keywords provided by TNO:

satiety; food intake; mood; wellness; weight management

Additional relevant MeSH terms:

5-Hydroxytryptophan; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs