Promotion of dietetic treatment with enhanced salt taste using Salt Chip
| ISRCTN | ISRCTN46450822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46450822 |
| Secondary identifying numbers | 0084CR |
- Submission date
- 10/07/2019
- Registration date
- 24/07/2019
- Last edited
- 24/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Adequate dietary intake to satisfy the nutrition requirement is particularly crucial for the patients who undergo invasive surgery, such as open heart surgery and large vessel surgery, to maintain the nutritional status, reduce edema, and start cardiac rehabilitation as early as possible during the perioperative period. However, this is often hindered by the physical damages in the mouth, reduction of the pylorus movement, and the lowered motivation by the surgery. In addition, dietary restriction of salt with the intake less than 6.0 g/day, which is reported to be effective as a nutrition therapy for cardiovascular diseases, often leads to further reduction of dietary intake due to the low-salt taste.
We consider that dietetic treatment to increase the food intake and thus improve the nutrition status during the perioperative period is of importance for good recovery of the patients. In this clinical trial, we focus on salt since salt is one of the major contributors to good taste while the intake is strictly restricted for the cardiovascular patients. We used Salt ChipⓇ to enhance the salt taste without increasing the salt intake. Salt ChipⓇ is attached onto the back of the lower front tooth and deliver salt directly to the tongue, which enables the patients to perceive strong salt taste even with as low as 0.05 g of salt. Dietetic treatment with Salt ChipⓇ should increase the eating amount of patients who underwent open heart surgery, which will promote recovery of the activities of daily life.
Who can participate?
Patients who undergo open heart surgery without severe frailty.
What does the study involve?
Participants of Group S are asked to use Salt ChipⓇ at every meal during their stay at the hospital except the first meal after the surgery. The participants of control group C do not use Salt ChipⓇ. The eating rate at each meal, which is 100% when a subject eats all the food provided and 0% when he/she did not eat any, is calculated from the weight of the food on the plates before and after the meal. Albumin (Alb g/dL), c-reactive protein (CRP mg/dL) and total cholesterol (T-cho mg/dL) are measured before the surgery, one day after the surgery (POD1), 7 days after the surgery (POD7), and when leaving the hospital (ENT).
Body composition is measured using InBody S10 (InBody Japan Inc., Tokyo, Japan), which includes body water balance, hydration percentage (%), total protein (g/dL), total fat (kg), skeletal muscle mass (kg), body cell mass (kg), and basal metabolic rate (kcal/day). The body water balance is the volumetric ratio of the extracellular water to the intracellular water. The hydration percentage is the ratio of the extracellular water amount to the body weight without fat. The measurement is conducted at 7:00 am before breakfast from POD1 to POD7 and at 16:00 pm before dinner in the preoperative period and from POD8 to POD14.
Progress of rehabilitation is evaluated by treadmills exercise. We assume that the subjects recover the activities of daily living (ADL) when they can conduct treadmills exercise for 20 min.
What are the possible benefits and risks of participating?
Enhanced salt taste using Salt ChipⓇ may increase the eating rate, which can be beneficial for fast recovery. Participants may percept too much salt taste, in which case the participants can drop out of the trial immediately.
Where is the study run from?
The study is conducted at Osaki Hospital Tokyo Heart Center.
When is the study starting and how long is it expected to run for?
March 2017 to June 2017.
Who is funding the study?
Keio University provides In-Body. LTaste Inc. provides Salt ChipⓇ. The remaining incidental costs are paid by Osaki Hospital Tokyo Heart Center.
Who is the main contact?
Dr. Minoru Yoshida
minoru.yoshida.tokyoheart@gmail.com
Contact information
Scientific
Osaki Hospital Tokyo Heart Center
5-4-12 Kita-Shinagawa
Shinagawa
Tokyo
141-0001
Japan
 ORCID ID |
0000-0002-6711-0306 |
|---|---|
| Phone | +81-3-5789-8100 |
| minoru.yoshida.tokyoheart@gmail.com |
Study information
| Study design | Interventional, nonblinded, parallel trial, single-centre |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Effect of dietetic treatment with enhanced salt taste in cardiovascular surgery perioperative period |
| Study acronym | SaltChip |
| Study hypothesis | 1. Enhanced salt taste promotes eating rate during the perioperative period. 2. Increased eating rate is beneficial in recovery from the surgery. |
| Ethics approval(s) | Approved, the ethics committee of Osaki Hospital Tokyo Heart Center (5-4-12 Kita-Shinagawa, Shinagawa, Tokyo, 141-0001, Japan; +81-3-5789-8100; +81-3-5789-8101), ref: 0084CR. |
| Condition | Open heart surgery patients |
| Intervention | The participants in the test group were requested to use Salt Chip®, which can enhance the salt taste without increasing the salt intake amount, at every meal. The duration of the intervention is from one day before the open heart surgery to ENT. The eating rate at each meal, which is 100% when a subject eats all the food provided and 0% when he/she did not eat any, was calculated from the weight of the food on the plates before and after the meal. Albumin (Alb g/dL), c-reactive protein (CRP mg/dL) and total cholesterol (T-cho mg/dL) were measured before the surgery, one day after the surgery (POD1), 7 days after the surgery (POD7), and when leaving the hospital (ENT). Body composition was measured using InBody S10 (InBody Japan Inc., Tokyo, Japan), which included body water balance, hydration percentage (%), total protein (g/dL), total fat (kg), skeletal muscle mass (kg), body cell mass (kg), and basal metabolic rate (kcal/day). The body water balance is the volumetric ratio of the extracellular water to the intracellular water. The hydration percentage is the ratio of the extracellular water amount to the bodyweight without fat. The measurement was conducted at 7:00 am before breakfast from POD1 to POD7 and at 16:00 pm before dinner in the preoperative period and from POD8 to POD14. Progress of rehabilitation was evaluated by treadmills exercise. We assumed that the subjects recovered the activities of daily living (ADL) when they could conduct treadmills exercise for 20 min. At approximately 2 weeks the patients who visited the hospital for open-heart surgery during the period were randomised to either the salt chip group or control group. The corresponding period was iterated. In addition, it was checked if there was any significant differences between the groups in terms of: age, sex, ejection fraction (EF), eating rate before the surgery, Alb, T-cho, body water balance, hydration percentage, total protein, total fat, skeletal muscle mass, body cell mass, and basal metabolic rate (p-value > 0.05). |
| Intervention type | Other |
| Primary outcome measure | The eating rate of the patients during the postoperative period is measured at each meal. |
| Secondary outcome measures | Progress of rehabilitation was evaluated by treadmills exercise every day. We assumed that the subjects recovered the activities of daily living (ADL) when they could conduct treadmills exercise for 20 min. |
| Overall study start date | 20/12/2016 |
| Overall study end date | 07/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Participant inclusion criteria | Open heart surgery patients |
| Participant exclusion criteria | 1. Unable to give informed consent and/or assent 2. Severe frailty |
| Recruitment start date | 18/03/2017 |
| Recruitment end date | 19/06/2017 |
Locations
Countries of recruitment
- Japan
Study participating centre
Tokyo
141-0001
Japan
Sponsor information
Hospital/treatment centre
5-4-12 Kita-Shinagawa, Shinagawa
Tokyo
141-0001
Japan
| Phone | +81-3-5789-8100 |
|---|---|
| minoru.yoshida.tokyoheart@gmail.com | |
| Website | http://www.tokyoheart.or.jp/department/ |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Private sector organisation / Universities (academic only)
- Alternative name(s)
- 게이오기주쿠대학, 庆应义塾大学, 慶應義塾, Keio
- Location
- Japan
Results and Publications
| Intention to publish date | 20/08/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | We are intending to publish the results in archived journal paper in 2019. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
18/07/2019: Trial's existence confirmed by the ethics committee of Osaki Hospital Tokyo Heart Center.
