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

This study has been completed.
Sponsor:
Collaborator:
Laboratoire Oenobiol
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00328913
First received: May 22, 2006
Last updated: January 8, 2007
Last verified: January 2007
  Purpose

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 Intervention Phase
Obesity
Drug: 5-hydroxytryptophan (food supplement)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effectiveness of 5-Hydroxytryptophan on Satiety in a Randomised, Placebo Controlled, Time Blinded Study, in Overweight Women

Resource links provided by NLM:


Further study details as provided by TNO:

Primary Outcome Measures:
  • satiety scores (visual analog scores)

Secondary Outcome Measures:
  • food intake
  • wellness
  • intermeal interval
  • body weight and waist-hip ratio

Estimated Enrollment: 24
Study Start Date: March 2006
Estimated Study Completion Date: July 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328913

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

No publications provided

ClinicalTrials.gov Identifier: NCT00328913     History of Changes
Other Study ID Numbers: P6880
Study First Received: May 22, 2006
Last Updated: January 8, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014