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GLY-LOW supplement for Inflammation

Phase < 1
Recruiting
Led By Melinda S Sothern, PhD
Research Sponsored by Hoskinson Health and Wellness Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-menopausal (>1 year from last menstrual cycle) adult females (>55 years of age) with obesity (BMI ≥ 30)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the screening/baseline visit and again during the 6-month follow-up visit.study participants will complete a 24hr food recall as recommended16. study personnel will download, process, and analyze the asa24 data per nci protocols
Awards & highlights

Study Summary

This trial aims to study the effects of a combination of safe compounds called GLY-LOW, which includes alpha lipoic acid, pyridoxamine, nicotinamide, piperine

Who is the study for?
This trial is for postmenopausal women over the age of 55 with obesity (BMI > 30). Participants should be healthy but may have issues like high cholesterol, insulin resistance, or a sedentary lifestyle. The study excludes details on who can't join.Check my eligibility
What is being tested?
The trial tests GLY-LOW, a supplement blend aimed at reducing caloric intake and improving insulin sensitivity and hormone levels in postmenopausal women. It's a one-group study without a placebo where effects are measured before and after 6 months of use.See study design
What are the potential side effects?
Specific side effects aren't listed, but safety will be monitored throughout the trial including metabolic disease risk, cardiovascular health, physical function, cognitive function, inflammation levels, and biological aging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 55, post-menopausal for more than a year, and have a BMI of 30 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the screening/baseline visit and again during the 6-month follow-up visit.study participants will complete a 24hr food recall as recommended16. study personnel will download, process, and analyze the asa24 data per nci protocols
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the screening/baseline visit and again during the 6-month follow-up visit.study participants will complete a 24hr food recall as recommended16. study personnel will download, process, and analyze the asa24 data per nci protocols for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fasting Insulin (I) and Glucose (G)
Glycosylated Hemoglobin [Hemoglobin A1C (HBA1C)]
Insulin Resistance (IR)
Secondary outcome measures
Biological Aging
Body Composition ) (lean mass, fat mass, bone density and area, central adiposity)
Cardiorespiratory Fitness
+14 more
Other outcome measures
Safety Outcomes

Trial Design

1Treatment groups
Experimental Treatment
Group I: GLY-LOW supplementExperimental Treatment1 Intervention
This supplement is available for over-the-counter purchase. 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 7:00 - 11:00 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.

Find a Location

Who is running the clinical trial?

Buck Institute for Research on AgingOTHER
2 Previous Clinical Trials
430 Total Patients Enrolled
Hoskinson Health and Wellness ClinicLead Sponsor
University of WyomingOTHER
17 Previous Clinical Trials
1,397 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enlist patients for this research study?

"Affirmative. The details available on clinicaltrials.gov indicate that this research project is presently seeking suitable participants. Initially shared on July 27, 2023, and last modified on January 29, 2024, the trial aims to recruit a total of 40 individuals at one designated site."

Answered by AI

Could you provide the overall count of participants involved in this research project?

"Indeed, the details available on clinicaltrials.gov indicate that this research endeavor is presently in search of suitable candidates. The trial was initially listed on July 27th, 2023 and most recently revised on January 29th, 2024. It aims to enroll a total of 40 participants from a solitary site."

Answered by AI

Who else is applying?

What site did they apply to?
Hoskinson Health and Wellness Clinic
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
Melinda Sothern 2023. "Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242535.
All > Paid Studies Wyoming > Binge Eating
~7 spots leftby Jul 2024
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