ObesityPhase 2NCT00328913
The Effect of 5-Hydroxytryptophan (5-HTP) on Satiety
A Phase 2 study testing 5-hydroxytryptophan (food supplement) in people with Obesity, run by TNO at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 5-hydroxytryptophan (food supplement)
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2006to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- Pregnant or lactating or wishing to become pregnant in the period of the study
- Recent blood or plasma donation (< 1 month prior to Day 01 of the study)
- Not willing to give up blood/plasma donation during the study
- Personnel of TNO Quality of Life (located in Zeist), their partners and their first and second degree relatives
- Not having a general practitioner
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of 5-Hydroxytryptophan on Satiety in a Randomised, Placebo Controlled, Time Blinded Study, in Overweight Women
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).
Read the detailed description
One of the physiological factors regulating the food intake pattern is satiety. Satiety is defined as the absence of ingestive motivation, which ends when the next meal is initiated (Blundell et al., 1996). Food intake affects a number of physiological objective parameters in blood known to be involved in signalling satiety, such as glucose (Melanson et al, 1999; Chapman et al, 1999; Campfield et al, 1996), insulin (Speechly et al, 2000) and cholecystokinin (CCK) (Gutzwiller et al., 2000; Beglinger et al., 2001; French et al., 2000; Degen et al., 2001; Burton-Freeman et al., 2002, 2004). More recently, the gastric hormone ghrelin was identified as a marker for hunger and meal initiation (De Graaf et al., 2004).
Humans do not only eat in response to a metabolic or physiological need. Humans also respond to a significant extent to other internal subjective and emotional signals (clues). The exact relations between the physiological internal signals and subjective and emotional internal signals are not known. Besides also external and social factors modulate physiological-derived hunger and satiety signals.
Though the regulation of food intake has been studied quite extensively, the underlying mechanism is not elucidated yet and still new factors involved in this regulation are being found. It is known that the macronutrients such as lipids, proteins and carbohydrates affect satiety differently, but this mechanism is still not very clear either.
Nowadays, more and more food supplements become available suggesting to affect hunger and satiety sensations, resulting in the long-term in weight loss. For example dietary fibres are known for their satiating effect.
The food supplement 5-HTP is used for this purpose as well. The food supplement, already available in the United States and in Italy, has been investigated for multiple indications such as migraine, depression, anxiety, fibromyalgia, hypertension, insomnia and obesity.
Different clinical studies have been performed with 5-HTP for more than three decades now. With respect to lowering of food intake, 5-HTP has been studied as well.
5-HTP is an amino acid produced by the human body from the essential amino acid L-tryptophan, which is found in food products. Its clinical value is the ability to increase production of serotonin. As a potentially valuable supplement it has been used clinically for more than 30 years. 5-HTP occurs naturally in two places - the human body and the seeds of the Griffonia simplicifolia, a West African medicinal plant.
5-HTP is the amino acid precursor of serotonin. Normal levels of serotonin are important for emotional well-being, may play a role in appetite suppression, and decreased carbohydrate and fat intake. Only free plasma tryptophan can cross the blood brain barrier via a carrier protein to enter the central nervous system (CNS). Once in the CNS, tryptophan is converted to 5-HTP and then is decarboxylated to serotonin. The levels, and possible function, of several neurotransmitters can be influenced by the supply of their dietary products. A reduction in tryptophan has been correlated to a reduction in serotonin (Curcio et al., 2005).
The 5-HTP metabolism is then influenced by plasma tryptophan levels, which are related to food intake. Serotonin synthesis is directly dependent on the availability of the specific precursor tryptophan and on the nutritional status.
The effect of 5-HTP intake on food intake and mood is based on the serotonin production. Numerous studies have shown that long-term consumption of 5-HTP (levels up to 900 mg daily) reduced food intake and resulted in weight loss.
In a previous study by Laboratoire Oenobiol with moderately overweight men aged 20-40 years, given 50 or 150 mg 5-HTP half an hour before lunch and half an hour before dinner, a reduced energy intake with 300 mg 5-HTP compared to placebo was found. This was supplied acutely on one day.
The study reported a linear dose related effect, with significant food intake inhibition effect with a 300 mg/day 5-HTP dose. The dose of 100 mg/day did not produce statistically significant effects compared to placebo. However, 100 mg of 5-HTP could prove to be sufficient if given under chronic administration conditions.
In the present study therefore subjects will be supplied with 100 mg 5-HTP daily for one week. Hunger and satiety feelings, food intake and wellness will be investigated. The study will be conducted with overweight women, assuming that this group of subjects will be the target group.
- Conditions
- Obesity
- Being tested
- 5-hydroxytryptophan (food supplement)
- Keywords
- satiety, food intake, mood, wellness, weight management
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-hydroxytryptophan (food supplement)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
satiety scores (visual analog scores)
Secondary outcomes (4)
food intake
wellness
intermeal interval
body weight and waist-hip ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startMar 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Oenobiol
- Investigators
- Wilrike Pasman, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328913
- Sponsor's protocol ID
- P6880
- Status last verified
- Jan 2007
- First submitted
- 22 May 2006
- Last updated
- 9 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 5-Hydroxytryptophan on Satiety in a Randomised, Placebo Controlled, Time Blinded Study, in Overweight Women
- ClinicalTrials.gov ID
- NCT00328913
- Acronym / sponsor ID
- P6880
- Conditions
- Obesity
- Keywords
- satiety, food intake, mood, wellness, weight management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Laboratoire Oenobiol
- Study start
- Mar 2006
- Study completion
- Jul 2006
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
One of the physiological factors regulating the food intake pattern is satiety. Satiety is defined as the absence of ingestive motivation, which ends when the next meal is initiated (Blundell et al., 1996). Food intake affects a number of physiological objective parameters in blood known to be involved in signalling satiety, such as glucose (Melanson et al, 1999; Chapman et al, 1999; Campfield et al, 1996), insulin (Speechly et al, 2000) and cholecystokinin (CCK) (Gutzwiller et al., 2000; Beglinger et al., 2001; French et al., 2000; Degen et al., 2001; Burton-Freeman et al., 2002, 2004). More recently, the gastric hormone ghrelin was identified as a marker for hunger and meal initiation (De Graaf et al., 2004).
Humans do not only eat in response to a metabolic or physiological need. Humans also respond to a significant extent to other internal subjective and emotional signals (clues). The exact relations between the physiological internal signals and subjective and emotional internal signals are not known. Besides also external and social factors modulate physiological-derived hunger and satiety signals.
Though the regulation of food intake has been studied quite extensively, the underlying mechanism is not elucidated yet and still new factors involved in this regulation are being found. It is known that the macronutrients such as lipids, proteins and carbohydrates affect satiety differently, but this mechanism is still not very clear either.
Nowadays, more and more food supplements become available suggesting to affect hunger and satiety sensations, resulting in the long-term in weight loss. For example dietary fibres are known for their satiating effect.
The food supplement 5-HTP is used for this purpose as well. The food supplement, already available in the United States and in Italy, has been investigated for multiple indications such as migraine, depression, anxiety, fibromyalgia, hypertension, insomnia and obesity.
Different clinical studies have been performed with 5-HTP for more than three decades now. With respect to lowering of food intake, 5-HTP has been studied as well.
5-HTP is an amino acid produced by the human body from the essential amino acid L-tryptophan, which is found in food products. Its clinical value is the ability to increase production of serotonin. As a potentially valuable supplement it has been used clinically for more than 30 years. 5-HTP occurs naturally in two places - the human body and the seeds of the Griffonia simplicifolia, a West African medicinal plant.
5-HTP is the amino acid precursor of serotonin. Normal levels of serotonin are important for emotional well-being, may play a role in appetite suppression, and decreased carbohydrate and fat intake. Only free plasma tryptophan can cross the blood brain barrier via a carrier protein to enter the central nervous system (CNS). Once in the CNS, tryptophan is converted to 5-HTP and then is decarboxylated to serotonin. The levels, and possible function, of several neurotransmitters can be influenced by the supply of their dietary products. A reduction in tryptophan has been correlated to a reduction in serotonin (Curcio et al., 2005).
The 5-HTP metabolism is then influenced by plasma tryptophan levels, which are related to food intake. Serotonin synthesis is directly dependent on the availability of the specific precursor tryptophan and on the nutritional status.
The effect of 5-HTP intake on food intake and mood is based on the serotonin production. Numerous studies have shown that long-term consumption of 5-HTP (levels up to 900 mg daily) reduced food intake and resulted in weight loss.
In a previous study by Laboratoire Oenobiol with moderately overweight men aged 20-40 years, given 50 or 150 mg 5-HTP half an hour before lunch and half an hour before dinner, a reduced energy intake with 300 mg 5-HTP compared to placebo was found. This was supplied acutely on one day.
The study reported a linear dose related effect, with significant food intake inhibition effect with a 300 mg/day 5-HTP dose. The dose of 100 mg/day did not produce statistically significant effects compared to placebo. However, 100 mg of 5-HTP could prove to be sufficient if given under chronic administration conditions.
In the present study therefore subjects will be supplied with 100 mg 5-HTP daily for one week. Hunger and satiety feelings, food intake and wellness will be investigated. The study will be conducted with overweight women, assuming that this group of subjects will be the target group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy as assessed by:
- 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
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-hydroxytryptophan (food supplement) | Drug | – |
Primary outcome
satiety scores (visual analog scores)
4 secondary outcomes
food intake
wellness
intermeal interval
body weight and waist-hip ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2007.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilrike Pasman, PhD principal investigator
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-hydroxytryptophan (food supplement) in people with Obesity, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satiety scores (visual analog scores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2007.