Trial · NCT06242535
Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
NCT06242535, Early phase 1, Completed, Hoskinson Health and Wellness Clinic
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity. Trials, record NCT06242535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06242535
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity
- NCT number
- NCT06242535
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Hoskinson Health and Wellness Clinic
- Conditions
Insulin Resistance, Obesity, Cardiovascular Diseases, Cognitive Impairment, Physical Disability, Depression, Inflammation, Hormone Deficiency, Physical Inactivity, Hyperlipidemias, Hypertension, Overeating
- Interventions
- GLY-LOW
- First posted
- 2024-02-05
- Last updated
- 2025-06-10
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insulin Resistance (IR) | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints. |
| Primary | Fasting Insulin (I) and Glucose (G) | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints. |
| Primary | Glycosylated Hemoglobin [Hemoglobin A1C (HBA1C)] | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints. |
| Primary | BMI [weight (kg) divided by height (m2)] | During the screening/baseline visit and again during the 6-month follow-up visit. | Total body weight and height were measured with an electronically calibrated scale and stadiometer (Pelstart Health-o-meter Professional 500KL) with participants in light, loose fitting clothing without shoes. |
| Primary | Body Composition [lean mass, fat mass, bone density and area, central adiposity (DEXA); waist circumference] | During the screening/baseline visit and again during the 6-month follow-up visit. | DEXA will be used for analysis of body composition using Hologics Horizon A DEXA. This machine is an FDA cleared-to market device. The procedure will be performed by trained technicians at the Hoskinson Health and Wellness Clinic. The study participants will be instructed to remove all metal and jewelry including their shoes before they are correctly positioned on the scan table, lying down on their back with their arms to their side. The DEXA will measure X-rays as they are transmitted through the study participant's body. The study participant will be exposed to ionizing radiation, but there is no discomfort during the measurement (0.02-0.03mR). This exposure is less than the 125mR/yr, which is the amount individuals receive from non-medical background radiation (Lunar). The low dose of radiation will not adversely affect the bone or surrounding tissue. |
| Secondary | Self-reported Caloric Intake | During the screening/baseline visit and again during the 6-month follow-up visit. | Assessed using the ASA24-2022 Dietary Assessment Tool. Study participants will complete a 24hr food recall. Study personnel will download, process, and analyze the ASA24 data per NCI protocols. |
| Secondary | Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglycerides (TRI) | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints. A small portion (approximately ½ teaspoon = 2.5 ml) of blood from the baseline and 6-month follow-up samples will be saved for future biomedical and molecular analysis. |
| Secondary | Systolic (SBP) and Diastolic Blood Pressure (DPB) | During the screening/baseline visit and again during the 6-month follow-up visit. | Resting SBP and DBP measured by a Welch Allen automated system. Two readings will be taken and averaged. If the two values differ by more than 5 mm Hg, an additional reading will be obtained. The study participant will abstain from eating and from heavy exercise for at least 2 hours prior to the test. Study participants will also be instructed not to ingest caffeine within 30 minutes before blood pressure measurements. The study participant will be comfortably seated, with the arm slightly flexed, palm up and the entire forearm supported at heart level on a smooth surface. Each measure will be directly recorded on the data spreadsheet in the study computer and the average score will be calculated by standard Microsoft functions. |
| Secondary | Metabolic Assessments at Rest | During the screening/baseline visit and again during the 6-month follow-up visit. | Resting energy expenditure (REE) and Respiratory Quotient (RQ) (Day 2) will be measured at rest.Individuals are instructed to fast for 12 hours prior to the test and are instructed not to engage in vigorous physical activity for 24 hours prior to the test. Individuals will be allowed to drink water prior to the test and will rest in a recumbent position for 30 minutes prior to the start of each testing session. Metabolic measurements will be continuously taken during the test. Expired gases will be sampled and analyzed for Volume of Oxygen (VO2) and Volume of Carbon Dioxide (VCO2) concentrations by indirect calorimetry calculated via a metabolic cart (Cosmed Quark CPET, Rome, Italy) using a canopy hood set up (Cosmed Quark RMR, Rome Italy). |
| Secondary | Thyroid Stimulating Hormone (TSH), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estrogen (E) and Progesterone (P4) | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints. A small portion (approximately ½ teaspoon = 2.5 ml) of blood from the baseline and 6-month follow-up samples will be saved for future biomedical and molecular analysis. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Eriksen Flanker Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06242535
GET https://conductscience.org/api/trials/v1/NCT06242535/registered?page=2