Trials / Unknown
UnknownNCT03974477
Study With an Innovative Equipment to Monitor and Control SALT During Cooking
Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- Universidade do Porto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
In this study, the researchers will evaluate the efficacy of an intervention using the SALT CONTROL H instrument (an innovative equipment to monitor and control salt) in workers at the University of Porto to reduce dietary salt intake. This is a randomized clinical trial with intervention conducted according to good clinical practice guidelines. The researchers will randomize 260 workers who meet the eligibility criteria and are enrolled in occupational health appointments. Prior to the intervention, the informed consent of the participants will be obtained and those who agree to participate will be allocated randomly in one of the two arms of the study (control or intervention), with balance of baseline characteristics (sex and hypertension). The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content, will be used an illustrative video and recipes with an adequate salt content; use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about "The new Food Wheel, a guide to the daily food choice!". Control Group: No intervention will be carried out except the provision of a leaflet on "The new Food Wheel, a guide to the daily food choice!" to the participants. Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention analysis will cover the following domains: urinary sodium excretion corresponding to a 24 hour urine collection as a proxy for salt intake; 24-hour urinary potassium excretion, sodium:potassium ratio, systolic and diastolic blood pressure, and anthropometric measurements. Urine samples will be collected according to standardized procedures and analyzed by a certified laboratory. Secondary data such as satisfaction questionnaire, daily use of equipment, iodine analysis of salt used and excreted in urine 24h, hydration status, analysis of quality of life and quality of diet will also be analyzed, as well as intestinal microbiota.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SALT CONTROL H equipment to control and monitor salt during cooking process | Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content. |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
- First posted
- 2019-06-05
- Last updated
- 2021-01-08
Locations
1 site across 1 country: Portugal
Source: ClinicalTrials.gov record NCT03974477. Inclusion in this directory is not an endorsement.