Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-01-29
Brief Title:
Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
Sponsor:
Hoskinson Health and Wellness Clinic
Organization:
Hoskinson Health and Wellness Clinic
Study Overview
Official Title:
Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A combination of generally regarded as safe GRAS compounds named GLY-LOW which included alpha lipoic acid pyridoxamine nicotinamide piperine and thiamine were examined in pre-clinical experiments GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice In female mice GLY-LOW supplementation reversed aging-related declines in female hormones Studies in humans are needed to examine the feasibility utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy postmenopausal females at birth with obesity by conducting a one-group no-placebo comparer pre post intervention clinical trial Additionally we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan The objectives of the proposed pilot study are
I Conduct a 6-month pilot study to examine the feasibility utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults 55 years with obesity 30 BMI
Ia Examine alterations in self-reported caloric intake and the following health and biological aging parameters prior to and after 6 months of GLY-LOW supplementation
1 Self-reported Caloric Intake
2 Metabolic disease risk
3 Cardiovascular disease risk
4 Metabolic assessments
5 Hormones
6 Physical Function and Fitness
7 Muscular strength
8 Cognitive Function and Depression assessments
9 Systemic inflammation
10 Biological aging
11 Safety parameters also every 2 months during the intervention ECG at baseline and 2 months only 12 Compliance measures pill counts and interviews every 2 months during the intervention
I Conduct a 6-month pilot study to examine the feasibility utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults 55 years with obesity 30 BMI
Ia Examine alterations in self-reported caloric intake and the following health and biological aging parameters prior to and after 6 months of GLY-LOW supplementation
1 Self-reported Caloric Intake
2 Metabolic disease risk
3 Cardiovascular disease risk
4 Metabolic assessments
5 Hormones
6 Physical Function and Fitness
7 Muscular strength
8 Cognitive Function and Depression assessments
9 Systemic inflammation
10 Biological aging
11 Safety parameters also every 2 months during the intervention ECG at baseline and 2 months only 12 Compliance measures pill counts and interviews every 2 months during the intervention
Detailed Description:
Study Population
Healthy postmenopausal 1 year from last menstrual cycle adult females at birth 55 years of age with obesity 25 BMI
ObjectivesPurpose of the Study
Worldwide rates of obesity increased from 100 million to 764 million between 1980 and 2021 During the same time frame a five-fold increase in Type 2 diabetes T2DM was reported4 Increases were similar across the globe with older individuals at greatest risk of obesity and related metabolic dysfunction Central obesity is well known to be both a manifestation and driver of metabolic syndrome5 with similar prevalence worldwide6 Older post-menopausal females in particular are at increased risk of developing central obesity due to a reduction in endogenous ovarian hormone production7 Novel multi-modal therapies are needed to address central obesity-related metabolic dysfunction in post-menopausal females However current therapeutic methods lack specificity and propose universal solutions to a multi-factorial disorder requiring an individualized precision medicine approach8 More concerning is the lack of rigorous scientific evidence to support conventional dietary therapies for reducing aging-related central obesity and associated metabolic dysfunction9 Targeting multiple biological pathways that are related to individual behavioral determinants caloric intake and biological aging markers estrogen levels may identify more precise therapies in post-menopausal female adults with obesity
Recently advanced glycation end-products AGEs were identified as potential drivers of obesity-related impaired metabolic function10 In a series of in vitro and in vivo experiments a combination of GRAS compounds that function synergistically to improve metabolic health and extend lifespan alpha lipoic acid pyridoxamine nicotinamide piperine and thiamine ie GLY-LOW were examined11-13 Supplementation with GLY-LOW was shown to detoxify methylglyoxal MGO a reactive precursor to AGEs In addition GLY-LOW supplementation reduced caloric intake and glycolysis reprogramed metabolism and increased insulin sensitivity and mTor signaling in the hypothalamus of the mice In female animals GLY-LOW supplementation reversed aging-related declines in estrogen and related female hormones Studies in humans are needed to translate these findings and explore the feasibility utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments These include increased metabolic disease risk and insufficiency impaired physical function osteoporosis reduced fitness levels cognitive impairment systemic inflammation and premature biological aging Interestingly results of a novel biological aging assessment retina scan were recently shown to be associated with metabolic dysfunction via inflammatory pathways14 The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown
Study Site
The Hoskinson Health and Wellness Clinic HHWC focuses on your whole health for your whole life and provides a proactive not reactive personalized and integrated multi-component solution to age-related increases in obesity and associated declines in metabolic health The HHWC utilizes functional precision medicine to identify unhealthy aging biomarkers and genetic vulnerabilities and innovative medical technology to both diagnose and manage aging-related metabolic physical and cognitive impairments State-of-the-art assessments identify targets for tailored programming including diet instruction nutrition education and supplementation fitness counseling and training The HHWC proposes to conduct a series of clinical studies using these state-of-the-art measures of aging-related parameters Initially we aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy postmenopausal females at birth with obesity by conducting a one-group no-placebo comparer pre post intervention clinical trial Additionally we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan The objectives of the proposed pilot study are
I Conduct a 6-month pilot study to examine the feasibility utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults 55 years with obesity 25 BMI
Ia Examine alterations in self-reported caloric intake and the following health and biological aging parameters prior to and after 6 months of GLY-LOW supplementation
1 Self-reported Caloric Intake
2 Metabolic disease risk
3 Cardiovascular disease risk
4 Metabolic assessments
5 Hormones
6 Physical Function and Fitness
7 Muscular strength
8 Cognitive Function and Depression assessments
9 Systemic inflammation
10 Biological aging
11 Safety parameters also every 2 months during the intervention ECG at baseline and 2 months only
12 Compliance measures pill counts and interviews every 2 months during the intervention
Trial Design
A The Primary Endpoint of the study is metabolic disease risk
C Design of the Trial
One group no-placebo comparer pre post intervention clinical trial
D Randomization and Blinding
The one group no-placebo comparer pilot study will not require randomization Study data managers and biostatisticians will be blinded to basic demographic and clinical characteristics eg female postmenopausal of the study population and the overall purpose of the trial
Initial RecruitmentScreening Enrollment and Baseline Evaluation
Recruitment screening and enrollment will occur during the first eight weeks of the study Approximately 40 participants will be screened and enrolled into the study Participation in the baseline evaluation will occur during weeks 9-12 Table 1 Recruitment will be by referrals personal interview brochure mail-outs to area physicians community center flyers and presentations presentations at civic meetings mass media announcements social media posts as well as clinic screenings as currently used in our existing studies and clinical services at the Hoskinson Health and Wellness Center The plan is described below
1 Potential study participants will be provided with a general information handout or link to our website regarding the study and contact information for participation
2 Study personnel will receive phone email inquiries or website inquiries and conduct a pre-screening interview and complete a checklist to determine eligibility
3 Study personnel andor other medical staff will then conduct the IRB-approved informed consent procedures and begin the screening process for study participants An explanation of all procedures potential risks temporary side effects anticipated benefits and alternative methods nutrition and fitness counseling weight loss pharmaceuticals or nutraceuticals other anti-aging therapeutics will be given to the study participant Confidentiality is assured as well as the right not to participate or to withdraw at any time The signature of the study participant will be obtained on the consent form A copy of the forms will be given to each study participant Assurance that all questions have been answered about the study testing is obtained from the participants Names and telephone numbers of contact persons on the medical team are given to each study participant for use if future questions arise
4 General health screenings will then be performed by qualified medical staff A medical physical evaluation to verify eligibility will be performed at the intervention baseline visits and a list of current medications will be required
5 After clearance by the study physician the study participant will receive the first set of baseline measurements The study coordinator will schedule the second day of baseline measurements with the study participant The study participant will be advised to fast for at least 12 hours prior to the second day of baseline testing
E Treatment Dosage and Dosing regimen of the GLY-LOW supplement
This supplement is available for over-the-counter purchase2 Each capsule is a combination of vitamins and natural products Vitamin B1 100mg Vitamin B6 50mg Niacin 200mg Alpha Lipoic Acid 150mg and Piperine 15mg Each participant will take this supplement daily in a pill form orally once in the morning The test product will be two capsules a day with breakfast between 700 - 1100 AM The chosen doses were based on dose conversion from mice to humans and the prior data on safety for each of the compounds in humans
F Description of the Dosage Form Packaging and Labeling of the GLY-LOW supplement
G Expected Duration of Subject Participation 34 weeks Figure 1 - Consort Diagram
I Available Alternative Treatments offered at the HHWC include nutrition and fitness counseling weight loss pharmaceuticals or nutraceuticals other anti-aging therapeutics Study participants will be provided with information concerning these alternative treatment therapies during the consent procedures
Follow-up Assessments
1 The study participant will attend a follow-up safety assessment visit every two months and will participate in blood tests and MSQ ECG will be assessed at baseline and 2 months only
2 The study participants will attend one follow-up assessment after 6 months of receiving the study supplement GLY-LOW Baseline measurements will be repeated during these follow-up assessments in order to examine the effectiveness of the intervention
Healthy postmenopausal 1 year from last menstrual cycle adult females at birth 55 years of age with obesity 25 BMI
ObjectivesPurpose of the Study
Worldwide rates of obesity increased from 100 million to 764 million between 1980 and 2021 During the same time frame a five-fold increase in Type 2 diabetes T2DM was reported4 Increases were similar across the globe with older individuals at greatest risk of obesity and related metabolic dysfunction Central obesity is well known to be both a manifestation and driver of metabolic syndrome5 with similar prevalence worldwide6 Older post-menopausal females in particular are at increased risk of developing central obesity due to a reduction in endogenous ovarian hormone production7 Novel multi-modal therapies are needed to address central obesity-related metabolic dysfunction in post-menopausal females However current therapeutic methods lack specificity and propose universal solutions to a multi-factorial disorder requiring an individualized precision medicine approach8 More concerning is the lack of rigorous scientific evidence to support conventional dietary therapies for reducing aging-related central obesity and associated metabolic dysfunction9 Targeting multiple biological pathways that are related to individual behavioral determinants caloric intake and biological aging markers estrogen levels may identify more precise therapies in post-menopausal female adults with obesity
Recently advanced glycation end-products AGEs were identified as potential drivers of obesity-related impaired metabolic function10 In a series of in vitro and in vivo experiments a combination of GRAS compounds that function synergistically to improve metabolic health and extend lifespan alpha lipoic acid pyridoxamine nicotinamide piperine and thiamine ie GLY-LOW were examined11-13 Supplementation with GLY-LOW was shown to detoxify methylglyoxal MGO a reactive precursor to AGEs In addition GLY-LOW supplementation reduced caloric intake and glycolysis reprogramed metabolism and increased insulin sensitivity and mTor signaling in the hypothalamus of the mice In female animals GLY-LOW supplementation reversed aging-related declines in estrogen and related female hormones Studies in humans are needed to translate these findings and explore the feasibility utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments These include increased metabolic disease risk and insufficiency impaired physical function osteoporosis reduced fitness levels cognitive impairment systemic inflammation and premature biological aging Interestingly results of a novel biological aging assessment retina scan were recently shown to be associated with metabolic dysfunction via inflammatory pathways14 The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown
Study Site
The Hoskinson Health and Wellness Clinic HHWC focuses on your whole health for your whole life and provides a proactive not reactive personalized and integrated multi-component solution to age-related increases in obesity and associated declines in metabolic health The HHWC utilizes functional precision medicine to identify unhealthy aging biomarkers and genetic vulnerabilities and innovative medical technology to both diagnose and manage aging-related metabolic physical and cognitive impairments State-of-the-art assessments identify targets for tailored programming including diet instruction nutrition education and supplementation fitness counseling and training The HHWC proposes to conduct a series of clinical studies using these state-of-the-art measures of aging-related parameters Initially we aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy postmenopausal females at birth with obesity by conducting a one-group no-placebo comparer pre post intervention clinical trial Additionally we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan The objectives of the proposed pilot study are
I Conduct a 6-month pilot study to examine the feasibility utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults 55 years with obesity 25 BMI
Ia Examine alterations in self-reported caloric intake and the following health and biological aging parameters prior to and after 6 months of GLY-LOW supplementation
1 Self-reported Caloric Intake
2 Metabolic disease risk
3 Cardiovascular disease risk
4 Metabolic assessments
5 Hormones
6 Physical Function and Fitness
7 Muscular strength
8 Cognitive Function and Depression assessments
9 Systemic inflammation
10 Biological aging
11 Safety parameters also every 2 months during the intervention ECG at baseline and 2 months only
12 Compliance measures pill counts and interviews every 2 months during the intervention
Trial Design
A The Primary Endpoint of the study is metabolic disease risk
C Design of the Trial
One group no-placebo comparer pre post intervention clinical trial
D Randomization and Blinding
The one group no-placebo comparer pilot study will not require randomization Study data managers and biostatisticians will be blinded to basic demographic and clinical characteristics eg female postmenopausal of the study population and the overall purpose of the trial
Initial RecruitmentScreening Enrollment and Baseline Evaluation
Recruitment screening and enrollment will occur during the first eight weeks of the study Approximately 40 participants will be screened and enrolled into the study Participation in the baseline evaluation will occur during weeks 9-12 Table 1 Recruitment will be by referrals personal interview brochure mail-outs to area physicians community center flyers and presentations presentations at civic meetings mass media announcements social media posts as well as clinic screenings as currently used in our existing studies and clinical services at the Hoskinson Health and Wellness Center The plan is described below
1 Potential study participants will be provided with a general information handout or link to our website regarding the study and contact information for participation
2 Study personnel will receive phone email inquiries or website inquiries and conduct a pre-screening interview and complete a checklist to determine eligibility
3 Study personnel andor other medical staff will then conduct the IRB-approved informed consent procedures and begin the screening process for study participants An explanation of all procedures potential risks temporary side effects anticipated benefits and alternative methods nutrition and fitness counseling weight loss pharmaceuticals or nutraceuticals other anti-aging therapeutics will be given to the study participant Confidentiality is assured as well as the right not to participate or to withdraw at any time The signature of the study participant will be obtained on the consent form A copy of the forms will be given to each study participant Assurance that all questions have been answered about the study testing is obtained from the participants Names and telephone numbers of contact persons on the medical team are given to each study participant for use if future questions arise
4 General health screenings will then be performed by qualified medical staff A medical physical evaluation to verify eligibility will be performed at the intervention baseline visits and a list of current medications will be required
5 After clearance by the study physician the study participant will receive the first set of baseline measurements The study coordinator will schedule the second day of baseline measurements with the study participant The study participant will be advised to fast for at least 12 hours prior to the second day of baseline testing
E Treatment Dosage and Dosing regimen of the GLY-LOW supplement
This supplement is available for over-the-counter purchase2 Each capsule is a combination of vitamins and natural products Vitamin B1 100mg Vitamin B6 50mg Niacin 200mg Alpha Lipoic Acid 150mg and Piperine 15mg Each participant will take this supplement daily in a pill form orally once in the morning The test product will be two capsules a day with breakfast between 700 - 1100 AM The chosen doses were based on dose conversion from mice to humans and the prior data on safety for each of the compounds in humans
F Description of the Dosage Form Packaging and Labeling of the GLY-LOW supplement
G Expected Duration of Subject Participation 34 weeks Figure 1 - Consort Diagram
I Available Alternative Treatments offered at the HHWC include nutrition and fitness counseling weight loss pharmaceuticals or nutraceuticals other anti-aging therapeutics Study participants will be provided with information concerning these alternative treatment therapies during the consent procedures
Follow-up Assessments
1 The study participant will attend a follow-up safety assessment visit every two months and will participate in blood tests and MSQ ECG will be assessed at baseline and 2 months only
2 The study participants will attend one follow-up assessment after 6 months of receiving the study supplement GLY-LOW Baseline measurements will be repeated during these follow-up assessments in order to examine the effectiveness of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None