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NCT06457711
Blood Pressure and Cardiometabolic Risk (Diet-to-HTN)
NA trial testing Free diet Group (FDG) in Arterial Hypertension in 50 participants. Completed in 22 June 2023.
22 June 2023
Quick facts
| Lead sponsor | University of Roma La Sapienza |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 50 |
| Start date | 22 June 2022 |
| Primary completion | 22 June 2023 |
| Estimated completion | 22 June 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Free diet Group (FDG)
- Very low Calorie Ketogenic Diet Group (VLCKDG)
- Intermittent Fasting Group (IFG)
Conditions studied
- Arterial Hypertension — all drugs for Arterial Hypertension →
- Menopause — all drugs for Menopause →
- Obesity — all drugs for Obesity →
- Cardiometabolic Syndrome — all drugs for Cardiometabolic Syndrome →
Sponsor
University of Roma La Sapienza
Who can join
Adults 50 to 65, female only, with Arterial Hypertension or Menopause. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Obesity is a significant health issue that increases the risk of serious cardiovascular problems. In recent years, two dietary methods, the Ketogenic Diet (KD) and Intermittent Fasting (IF), have become popular for their potential to treat obesity and its related issue, hypertension. While both diets are known for their effectiveness in weight loss, their specific impacts on blood pressure (BP) and overall heart health risks are less understood especially in menopausal women. The main goal of this study was to investigate how the Ketogenic Diet and Intermittent Fasting compare to a regular, unrestricted diet (referred to as Free Diet or FD) in terms of their effects on clinic blood pressure levels in menopausal women. Additionally, the study looked at changes in Body Mass Index (BMI), the percentage of total body weight loss, body fat percentage, waist and hip measurements, the ratio of waist-to-hip size, and the Phase Angle (PhA), which is a measure of the body's overall health status.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06457711
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Roma La Sapienza trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06457711 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Roma La Sapienza
- Last refreshed: 16 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06457711.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing