Serial assessment of gastric contents using MRI

JRCT ID: jRCT1042240046

Registered date:14/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult: Evaluate gastric emptying time after oral intake of solid food
• Date of first enrollment: 14/06/2024
• Target sample size: 36
• Study type: Interventional

Intervention(s)

Group A: MRI scan after ingestion of solid meal according to Japanese diet (888 kcal)
Group B: MRI scan after ingestion of solid foods according to Western diet (890 kcal)
Group C: MRI scan after ingestion of solid foods according to dairy products (882 kcal)

Outcome(s)

• Primary Outcome: changes in gastric contents over time
• Secondary Outcome: blood sugar level

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1) Healthy ( ASA-PS class 1 or 2 )
2) Gender: male
3) BMI: 18.5 - 30 kg/m2
4) Age at consent: between 18 and 45 years old
5) After receiving sufficient explanation about participation in this study and with full understanding, the subject must give his/her free and voluntary consent in writing and sign a consent form

Exclude criteria

1) Those with a history of allergy to the test food
2) Those with a factor of delayed gastric contents evacuation
(1) Those with abnormal gastrointestinal motility
(2) Those diagnosed with any of the following diseases known to be associated with abnormal gastrointestinal motility. Gastric insufficiency paralysis, amyloidosis, neuromuscular disease (including Parkinson's disease), collagen vascular disease, alcoholism, uremia, malnutrition, untreated hypothyroidism
(3) Morbidly obese with BMI > 30 kg/m2
(4) History of active or severe peptic ulcer
(5) Diabetes mellitus
(6) Known history of gastrointestinal surgery
(7) Esophageal hiatal hernia
(8) Signs of gastroesophageal reflux esophagitis
(9) Patients who have taken medications that affect gastric acid secretion or evacuation within 48 hours of study participation
3) Inability to perform MRI
(1) Wearing implants, metal or non-removable braces on the body
(2) Claustrophobia
(3) Patients who have a phobia of claustrophobia
(4) Patients with congestive heart failure
(5) Patients who have taken antimicrobial agents within 30 days prior to the study date
(6) Other patients judged by the principal investigator or subinvestigator to be inappropriate as subjects for the study

Related Information

• Primary Sponsor: Goto Takashi