Trial · NCT07886788
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in circulating plasma microRNA expression | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Differential expression of circulating microRNAs in plasma, comparing changes from baseline between the grape supplementation and control arms at the end of the intervention and after follow-up. |
| Secondary | Change in DNA methylation in promoter regions of selected genes | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Changes in DNA methylation in the promoter regions of selected genes, measured by pyrosequencing after bisulfite treatment of DNA isolated from peripheral blood mononuclear cells (PBMCs). Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and after follow-up. |
| Secondary | Change in serum metabolomic profile | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Changes in the serum metabolomic profile assessed by proton nuclear magnetic resonance (1H-NMR). Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and after follow-up. |
| Secondary | Change in gut microbiota diversity and composition | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Changes in bacterial diversity and composition assessed by 16S ribosomal RNA gene sequencing of stool samples. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and after follow-up. |
| Secondary | Change in body weight | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in body weight, measured in kilograms, from baseline to the end of the intervention and follow-up, comparing the grape supplementation and control arms. |
| Secondary | Change in body mass index | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared (kg/m²), from baseline to the end of the intervention and follow-up, comparing the grape supplementation and control arms. |
| Secondary | Change in waist circumference | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in waist circumference, measured in centimeters, from baseline to the end of the intervention and follow-up, comparing the grape supplementation and control arms. |
| Secondary | Change in body composition assessed by bioelectrical impedance | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Changes in body composition assessed using a TANITA bioelectrical impedance device, comparing changes from baseline between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in systolic and diastolic blood pressure | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Changes in resting systolic and diastolic blood pressure, measured in mmHg using two readings taken one minute apart. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in resting heart rate | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in resting heart rate, measured in beats per minute, from baseline to the end of the intervention and follow-up, comparing the grape supplementation and control arms. |
| Secondary | Change in handgrip strength | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in handgrip strength assessed by handgrip dynamometry, comparing changes from baseline between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in gait speed over a 4-meter distance | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in gait speed, measured in meters per second using a 4-meter walk test to assess functional performance. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in fasting blood glucose | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in fasting blood glucose measured using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in fasting insulin | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in fasting insulin measured using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in glycated hemoglobin (HbA1c) | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5) | Change in glycated hemoglobin (HbA1c) measured using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in blood creatinine | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5) | Change in blood creatinine measured using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in liver enzyme levels | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5) | Changes in blood liver enzyme levels measured using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in blood lipid profile | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5) | Changes in the blood lipid profile measured using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in prothrombin measurements | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5) | Changes in prothrombin measurements assessed using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
| Secondary | Change in blood ferritin | Baseline (week 0), end of intervention (week 3), and end of follow-up (week 5). | Change in blood ferritin measured using standardized clinical laboratory methods. Changes from baseline will be compared between the grape supplementation and control arms at the end of the intervention and follow-up. |
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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