Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328913
Status:
COMPLETED
Last Update Posted:
2007-01-09
First Post:
2006-05-22
Brief Title:
The Effect of 5-Hydroxytryptophan 5-HTP on Satiety
Sponsor:
TNO
Organization:
TNO
Study Overview
Official Title:
Effectiveness of 5-Hydroxytryptophan on Satiety in a Randomised Placebo Controlled Time Blinded Study in Overweight Women
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mgday 5-HTP dose The dose of 100 mgday 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
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 mgday 5-HTP dose The dose of 100 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None