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

NCT00328913 | Completed Phase 2

• 1 other identifier: P6880
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

satiety; food intake; mood; wellness; weight 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy as assessed by:
• The TNO health and lifestyle questionnaire
• 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

Sponsors & Collaborators

• TNO: lead
• Laboratoire Oenobiol: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3704HE, Netherlands

Location

MeSH Terms

Conditions

Obesity

Interventions

5-Hydroxytryptophan; Dietary Supplements

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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 1, 2006
• Study Completion: July 1, 2006
• Last Updated: January 9, 2007

Record last verified: 2007-01

Locations

NL (1)