Trial · NCT06242535
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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. |
| Secondary | Physical Function | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by the short physical performance battery as follows: The short physical performance battery is comprised of three performance measures: 1) The standing balance test requires study participants to maintain their feet in a side-by-side, semi-tandem stand, or tandem stand for 10 seconds. 2) A test of walking speed where study participants walk for 4 minutes at a normal pace; 3) The chair stand test, which evaluates lower extremity extensor muscle strength by measuring the time required for the participants to stand up and sit down from a chair five times with arms folded across the chest. Each performance measure is scored from 1-4 points (maximum 12 points). This test can be accomplished in 15 minutes. |
| Secondary | Muscular Strength | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by administering the hand grip test as follows: The hand-grip strength procedure of the Hand-Held Dynamometer (Baseline) will be administered to patient participants seated in a chair with a back support and fixed arm rests using a calibrated instrument. The study participants will position their thumb around one side of the instrument and their fingers along the other side of the handle. They will be instructed to squeeze the handle as long and as tightly as possible. Three measures will be recorded for each hand, alternating sides. This procedure is shown to be a valid and feasible method of assessing muscular strength in elderly adults20-21. |
| Secondary | Cardiorespiratory Fitness | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by a graded submaximal treadmill test using a modified Balke protocol 22. A warm-up session of approximately 5 minutes will establish comfortable walking speeds. Study participants will then walk on the treadmill for 2-minute warm-up at 0% grade, the grade of the treadmill will then be increased by 2.5% every 2 minutes until the participant can no longer continue or reaches 80% of age-predicted volume of oxygen (VO2) peak. Following the warm-up session, VO2 and carbon dioxide VCO2 production, ventilation (VE) and respiratory exchange ratio (RER) will be calculated via a metabolic cart (Cosmed Quark CPET, Rome, Italy) and a two-way non-re-breathing mask (Cosmed K2 Mask, Rome, Italy). |
| Secondary | Cognitive Function by the Mini-Mental State Examination (MMSE) | During the screening/baseline visit and again during the 6-month follow-up visit. | The Mini Mental State Examination (MMSE) will be administered per standard protocol with the cut-off of 26. The MMSE is comprised of 30 questions that assesses cognitive function by evaluating attention and orientation, memory, registration, recall, calculation, language and ability to draw a complex polygon. The MMSE exhibits high levels of acceptance as a diagnostic instrument in both health care providers and researchers25. The MMSE is available in numerous language translations and can be administered in less than one hour. |
| Secondary | Executive Function (EF), Cognitive Flexibility (CF) and Mental Control (MC) | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by the Advanced Digital Cognitive Assessment of (BrainCheck28-29) which is a tablet-based version of six neurocognitive tests, which can be completed in 30 minutes: 1) Flanker Task, 2) Digit Symbol Substitution Test, 3) Stroop Task, 4) The Trail Making Test, 5) Balance and Coordination, 6) The Immediate and Delayed Recall Tests |
| Secondary | Depression | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured by the Center for Epidemiologic Studies Depression Scale (CES-D Scale)30. Study participants are asked to read each question of a 20 item scale carefully, then circle one of the numbers to the right to indicate how they felt or behaved during the past week, including the assessment day. Options include: (0) Rarely or none of the time (less than 1 day), (1) Some or a little of the time (1-2 days), (2) Occasionally or a moderate amount of the time (3-4 days), (3) Most or all of the time (5-7 days). The test can be completed in approximately 10 minutes. The responses are totaled by the test administrator and the possible range of scores is between 0 to 60. Higher scores indicate the presence of more symptomatology of depression. |
| Secondary | Systemic Inflammation | During the screening/baseline visit and again during the 6-month follow-up visit. | assessed by measuring serum pro-and-anti- inflammatory markers, which will be obtained by simple blood draw as described above and evaluated by Enzyme Linked Immunoassay (ELISA); the panel will measure pro- and anti-inflammatory factors and cytokines previously shown to be associated with metabolic disease, obesity and aging. These include: C-Reactive Protein (hs-CRP). Blood samples will then be stored at -70 degrees Celsius in a freezer at the HHWC. The blood samples will then be shipped to the Buck Institute/USF for analysis. A commercially available kit for sTNFR1 human ELISA kit (Biosource international, CA) will be utilized. |
| Secondary | Total Body Weight | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured with an electronically calibrated scale (Pelstart Health-o-meter Professional 500KL) will be used to obtain the weight in kilograms of each study participant. The study participant will remove her shoes and step on the scale. The study participant will remain as still as possible. The study participant's weight in kilograms will be recorded once the digital reading is constant. The study participant will remain on the scale until the weight is recorded. The process will be repeated two additional times. |
| Secondary | Height | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured with a calibrated stadiometer (Pelstart Health-o-meter Professional 500KL) will be used to obtain the height in centimeters of each study participant. The study participant will remove her shoes and step onto the floor platform facing in an outward direction with the heels together. The scapula and buttocks will remain in contact with the back of the stadiometer during the measure. The head will be positioned in a horizontal plane. The clinician will move the headboard onto the most superior aspect of the study participant's head. This procedure will be repeated two additional times. The average height in to the nearest tenth of a centimeter (0.1 cm) will be calculated on the data statistical form. |
| Secondary | Waist Circumference | During the screening/baseline visit and again during the 6-month follow-up visit. | Measured in study participants with a tape measure. The measurement of girth at the waistline provides an estimation of central adiposity17. Individuals will wear light clothing for this measurement. They are asked to stand erect and in an upright position with abdomen relaxed, arms at sides and feet together. Measures are made at the end of normal expiration at the umbilicus. The measurements are recorded to the nearest 0.1 cm. This process is repeated and the average of each of the two circumferences is used in analysis (a third measurement is obtained if the first two measurements are greater than 0.5 cm apart). Figure 1 provides a graphic representation of the measurement site for waist circumference. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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