Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01508741
Status:
COMPLETED
Last Update Posted:
2013-03-20
First Post:
2012-01-09
Brief Title:
Use Of The Dietary Supplement 5-ALA And Its Relationship With Sleep And Mood
Sponsor:
University of Hawaii
Organization:
University of Hawaii
Study Overview
Official Title:
Supplement 5-ALA And Sleep And Mood Study
Status:
COMPLETED
Status Verified Date:
2013-03
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:
PURPOSE The purpose of this investigation is to determine if a relationship exists between the administration of a dietary supplement containing 5-ALA and sleep and mood
HYPOTHESIS There are several possible mechanisms for improvement in sleep and mood In one study involving test mice researchers found that the regular administration of 5-ALA appeared to raise serotonin levels in the brain One hypothesis is by increasing serotonin levels 5-ALA may contribute to improvements with sleep along with additional improvements in mood calmness irritability and coping abilities 5-ALA may also support hormonal regulation including melatonin in the pineal gland and corticosteroid regulation in the adrenal glands
Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism of cells such that its own circadian rhythms are better defined 5-ALA may support neuronal function and assistance with mental energy needed to deal with stress in daily life producing better feelings of coping less irritability and lowering an individuals feelings of fatigue all of which may contribute to a reduction of pessimism regarding the ability to deal with daily tasks
DESIGN This will be a double-blinded randomized parallel-group comparison study
SAMPLE 40 participants will be randomized to the following 2 study groups for each outcome variable Sleep and Mood Control Group - 20 participants and Intervention Group - 20 participants A table of random numbers will be used to assign the participants
HYPOTHESIS There are several possible mechanisms for improvement in sleep and mood In one study involving test mice researchers found that the regular administration of 5-ALA appeared to raise serotonin levels in the brain One hypothesis is by increasing serotonin levels 5-ALA may contribute to improvements with sleep along with additional improvements in mood calmness irritability and coping abilities 5-ALA may also support hormonal regulation including melatonin in the pineal gland and corticosteroid regulation in the adrenal glands
Another hypothesis is that 5-ALA may have an impact on increasing the energy and metabolism of cells such that its own circadian rhythms are better defined 5-ALA may support neuronal function and assistance with mental energy needed to deal with stress in daily life producing better feelings of coping less irritability and lowering an individuals feelings of fatigue all of which may contribute to a reduction of pessimism regarding the ability to deal with daily tasks
DESIGN This will be a double-blinded randomized parallel-group comparison study
SAMPLE 40 participants will be randomized to the following 2 study groups for each outcome variable Sleep and Mood Control Group - 20 participants and Intervention Group - 20 participants A table of random numbers will be used to assign the participants
Detailed Description:
5-Aminolevulinic Acid 5-ALA is a dietary supplement and a naturally occurring amino acid It is a natural delta amino acid as a non-alpha amino acid it is not a component of proteins 5-ALA is synthesized in the mitochondria and is the first compound in the prophyrin synthesis pathway the pathway that leads to heme in mammals and chlorophyll in plants 5-ALA has been associated with genetic information structure and metabolism and energy conversion
5-ALA can be found in many common foods such as spinach tomatoes shitake mushrooms potatoes squid ground beef wine and soy sauce The normal intake from food containing 5-ALA is 1-2 mgday 5-ALA is synthesized by the body at a rate of 600 mgday
Data has supported the hypothesis that supplementation with 5-ALA may be related to improved sleep mood and coping abilities This research study will further explore this potential relationship
The duration of the study for each participant is a total of 10 weeks which include 4 separate appointments spaced 3-4 weeks apart Participants in the Intervention Group will begin taking one daily 50 mg capsule po of 5-ALA over a 6 week period and the Control Group will be provided with a placebo of similar size and color
Before entering the research study each participant undergoes a thorough screening process including lab work CBC and Ferritin Once accepted into the study the daily capsules are started and a diary is filled out by each participant at home each day and brought to each appointment for review Instructions are given to record patterns and changes pertaining to sleep mood or coping abilities After 6 weeks the participant is then instructed to stop the daily capsules but to continue daily diary recordings They are also scheduled for one final appointment at week 10 At each of the 4 appointments over the 10 week period assessments are performed by health care professionals questionnaires and daily diaries are reviewedrecorded and anthropometric measurements are obtained
The product used in this investigation contains 3 components
5-Aminolevulinic acid 5-ALA phosphate
Sodium Ferrous Citrate SFC
Corn starch as filler
The 5-ALA capsules and contents are Non-GMO BSE free and alcohol free The products tested are manufactured under food GMP conditions A certificate of analysis is available
Variables monitored as part of the evaluation will be assessed by comparing the intervention group to the control group Two-sample t-tests will be used to assess statistical significance at baseline and follow-up exams Baseline data will be summarized as means and standard deviations with differences among the randomized groups tested for significance by t-tests and chi-square tests To measure the possible differences in rates of change in sleep and mood scores across follow-up time between the 5-ALA treatment and the control group additional analyses will estimate differences in slopes using linear regression models Mixed linear models will be fit using the proc mixed procedure in SAS 92 The regression models will include an indicator variable identifying treatment groups a variable for weeks of follow-up and interaction terms between the indicator variables and follow-up time Results will be summarized as the difference in slopes comparing the intervention groups to the control group Results will also be presented graphically to illustrate the estimated differences in slopes for the study groups All significant tests will be two-sided
5-ALA can be found in many common foods such as spinach tomatoes shitake mushrooms potatoes squid ground beef wine and soy sauce The normal intake from food containing 5-ALA is 1-2 mgday 5-ALA is synthesized by the body at a rate of 600 mgday
Data has supported the hypothesis that supplementation with 5-ALA may be related to improved sleep mood and coping abilities This research study will further explore this potential relationship
The duration of the study for each participant is a total of 10 weeks which include 4 separate appointments spaced 3-4 weeks apart Participants in the Intervention Group will begin taking one daily 50 mg capsule po of 5-ALA over a 6 week period and the Control Group will be provided with a placebo of similar size and color
Before entering the research study each participant undergoes a thorough screening process including lab work CBC and Ferritin Once accepted into the study the daily capsules are started and a diary is filled out by each participant at home each day and brought to each appointment for review Instructions are given to record patterns and changes pertaining to sleep mood or coping abilities After 6 weeks the participant is then instructed to stop the daily capsules but to continue daily diary recordings They are also scheduled for one final appointment at week 10 At each of the 4 appointments over the 10 week period assessments are performed by health care professionals questionnaires and daily diaries are reviewedrecorded and anthropometric measurements are obtained
The product used in this investigation contains 3 components
5-Aminolevulinic acid 5-ALA phosphate
Sodium Ferrous Citrate SFC
Corn starch as filler
The 5-ALA capsules and contents are Non-GMO BSE free and alcohol free The products tested are manufactured under food GMP conditions A certificate of analysis is available
Variables monitored as part of the evaluation will be assessed by comparing the intervention group to the control group Two-sample t-tests will be used to assess statistical significance at baseline and follow-up exams Baseline data will be summarized as means and standard deviations with differences among the randomized groups tested for significance by t-tests and chi-square tests To measure the possible differences in rates of change in sleep and mood scores across follow-up time between the 5-ALA treatment and the control group additional analyses will estimate differences in slopes using linear regression models Mixed linear models will be fit using the proc mixed procedure in SAS 92 The regression models will include an indicator variable identifying treatment groups a variable for weeks of follow-up and interaction terms between the indicator variables and follow-up time Results will be summarized as the difference in slopes comparing the intervention groups to the control group Results will also be presented graphically to illustrate the estimated differences in slopes for the study groups All significant tests will be two-sided
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