GLY-LOW Supplementation for Obesity

Overseen By Melinda S Sothern, PhD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Hoskinson Health and Wellness Clinic

Must not be taking: Hormone therapy, Weight loss drugs

Disqualifiers: Gout, Cardio-metabolic disease, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants who are on various prescription medications, including those for chronic diseases, blood thinners, and supplements that might interact with GLY-LOW.

What data supports the effectiveness of the GLY-LOW treatment for obesity?

Research suggests that diets with a low glycemic index (a measure of how quickly foods raise blood sugar levels) can help with weight loss and reduce obesity-related risks, which may support the effectiveness of GLY-LOW for obesity. ^{1 2 3 4 5}

How does the GLY-LOW treatment for obesity differ from other treatments?

GLY-LOW is unique because it focuses on a low glycemic index/load approach, which may help manage obesity by potentially reducing body weight and fat mass through improved blood sugar control and satiety. This approach is different from other treatments that might not specifically target the glycemic index or load of foods. ^{1 4 6 7 8}

What is the purpose of this trial?

This trial tests a supplement called GLY-LOW, which combines several vitamins and natural compounds. It aims to help postmenopausal women over 55 with obesity by improving their metabolism and hormone levels. The study will check if GLY-LOW can reduce calorie intake and improve overall health.

Research Team

Sanjay Dhar, PhD

Principal Investigator

Hoskinson Health and Wellness Clinic

Daniela Gerard, MD, PhD

Principal Investigator

Hoskinson Health and Wellness Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am a woman over 55, post-menopausal for more than a year, and have a BMI of 30 or higher.

Exclusion Criteria

I am an adult female with a moderate to severe disability.

I am not willing to travel to a clinic for the study.

I am male.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Multiple visits for screening and baseline evaluation

Baseline Evaluation

Baseline measurements and evaluations are conducted

4 weeks

In-person visits for baseline measurements

Treatment

Participants receive GLY-LOW supplementation daily for 6 months

24 weeks

Follow-up safety assessment visits every 2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up assessment after 6 months of treatment

Treatment Details

Interventions

• GLY-LOW

Trial Overview 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.

Participant Groups

Group I: GLY-LOW supplement Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Hoskinson Health and Wellness Clinic

Lead Sponsor

Trials

2

Recruited

80+

Buck Institute for Research on Aging

Collaborator

Trials

6

Recruited

1,200+

University of Wyoming

Collaborator

Trials

20

Recruited

1,600+

Findings from Research

A meta-analysis of 14 randomized controlled trials found that long-term low glycemic index/load (GI/GL) diets significantly reduced fasting insulin levels and C-reactive protein, which are important markers for obesity-related health risks.

While low GI/GL diets showed benefits in reducing certain biomarkers, they also resulted in a significant decrease in fat-free mass, indicating a need for careful monitoring of body composition during such dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of low glycemic index/load vs. high glycemic index/load diets on parameters of obesity and obesity-associated risks: a systematic review and meta-analysis. Schwingshackl, L., Hoffmann, G.[2022]

Obesity has more than doubled in the U.S. over the past 30 years, leading to increased risks for serious health issues like type 2 diabetes and certain cancers, highlighting the urgent need for effective treatment and prevention strategies.

Current treatment options for obesity include lifestyle changes, FDA-approved medications like sibutramine and orlistat, and bariatric surgery, but the review emphasizes the importance of evaluating the safety and efficacy of various weight-loss diets and over-the-counter supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perspective on the current strategies for the treatment of obesity. Joyal, SV.[2019]

A systematic review of 11 randomized control trials involving 634 children found that low glycemic index (LGI) and low glycemic load (LGL) diets did not lead to significant changes in body weight, BMI, or waist circumference compared to control diets.

The study suggests that LGI and LGL diets do not improve cardiometabolic or glucometabolic health markers in children with overweight or obesity, indicating a need for further research to explore their potential benefits against high glycemic index diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Low Glycemic Index/Load Diet on Cardiometabolic, Glucometabolic, and Anthropometric Indices in Children with Overweight or Obesity: A Systematic Review and Meta-Analysis. Kalaitzopoulou, I., Theodoridis, X., Kotzakioulafi, E., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term effects of low glycemic index/load vs. high glycemic index/load diets on parameters of obesity and obesity-associated risks: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Associations between Diet Behaviors and Measures of Glycemia, in Clinical Setting, in Obese Adolescents. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A perspective on the current strategies for the treatment of obesity. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Validation of a food frequency questionnaire in the assessment of dietary glycemic index, glycemic load, and protein intake in pregnant women with obesity. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effect of dose of behavioral weight loss treatment on glycemic control in adults with prediabetes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Chronologically scheduled snacking with high-protein products within the habitual diet in type-2 diabetes patients leads to a fat mass loss: a longitudinal study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Low Glycemic Index/Load Diet on Cardiometabolic, Glucometabolic, and Anthropometric Indices in Children with Overweight or Obesity: A Systematic Review and Meta-Analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Association between dietary carbohydrate, glycemic index, glycemic load, and the prevalence of obesity in Korean men and women. [2015]