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A Randomized, Multi-center Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation

A Randomized, Multi-center Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation - Trial for the Effects of Dietary Instruction on Cardiovascular Risk Markers after Smoking Cessation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030282
Enrollment
250
Registered
2017-12-06
Start date
2017-09-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nicotine dependency

Interventions

Intervention group An intervention period: Nine months Nourishment instruction: Three times (once in three months). Non Intervention group An intervention period: Nine months Nourishment instructi

Sponsors

National Hospital Organization Kyoto Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients who succeed in smoking cessation at the time of the fifth visit (Definition of success in smoking cessation: expired carbon monoxide concentration of less than 7 ppm and the patient affirmation of no smoking for one week (2)Patients within one month from the fifth visit (3)Patients with weight gain more than 1kg from the first visit to the fifth visit to smoking cessation clinic (4)Pacients who gave informed written consent

Exclusion criteria

Exclusion criteria: (1)Patients who receive nourishment instruction regularly (2)Patients in an unfavorable state for nourishment instruction enforcement (e.g., shock state, serious infectious disease,acute phase of cerebral infarction or myocardial infarction, terminal stage of cancer, remarkabe gastrointestinal weakness) (3)Pregnancy or breastfeeding patients (4)Patients who take steroid regularly (5)Patients with uncontrolled diabetes mellitus (with HbA1c level more than 10.0%) (5)Patients who are judged to be unsuitable to paticipate in this clinical trial by a doctor (e,g,. patients with advanced dementia)

Design outcomes

Primary

MeasureTime frame
Cardiovascular risk marker: AT-LDL, SAA-LDL, high sensitivity CRP, LOX index, adiponectin

Secondary

MeasureTime frame
Glucose and lipid metabolism (HbA1c, LDL-C, HDL-C, non-HDL-C, leptin), body weight (BMI) and waist circumference, continuous abstinence rate from smoking

Countries

Japan

Contacts

Public ContactKoji Hasegawa

National Hospital Organization Kyoto Medical Center Division of Translational Research

koj@kuhp.kyoto-u.ac.jp075-641-9161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026