Fat Supplementation on Dumping Syndrome Associated Symptoms

Not Applicable

Recruiting

• Conditions: Dumping Syndrome
• Interventions: Dietary Supplement: Resource Energy; Dietary Supplement: Calogen

• Registration Number: NCT04028193
• Lead Sponsor: Technological Educational Institute of Thessaly

Brief Summary

The purpose of the study is the investigation of the effect of fat supplement on gastric emptying rate and the appearance of symptoms of Dumping Syndrome in patients who have undergone gastrointestinal- duodenal surgery. Patients who have undergone bariatric surgery have been examined for the presence of the Dumping syndrome, with glucose measurements, the Sigstad's questionnaire and questionnaire of Arts. Patients diagnosed positive, reiterated the examination process in a second meeting consuming an extra fat supplement. The data obtained on the different appointments were compared between the two groups in a cross over design.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-12
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-12
• Last Update Posted: 2022-11-15
• Primary Completion: 2022-12
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with Dumping Syndrome

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Exclusion Criteria

• Patients with diabetes mellitus type 1 and 2, Patients with impaired balance of fluids and electrolytes, Patients on diuretics pills or corticosteroids or hypoglycemic tablets and Insulin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diagnose Dumping after supplement consumption	Resource Energy	Carbohydrate ingestion to provoke dumping syndrome related symptoms
Fat supplementation	Calogen	A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.

Primary Outcome Measures

Name	Time	Method
Arts's Questionnaire	2nd hour after the ingestion of the supplements	Dumping syndrome symptom associated questionnaire
Glucose Levels	120 minutes after the ingestion of the the carbohydrate and fat supplement	Blood glucose measurement
Sigstad's Questionnaire	2nd hour after the ingestion of the supplements	Dumping syndrome symptom associated questionnaire

Trial Locations

Locations (1)

Nikoleta Chatzipapa; 🇬🇷 Thessaloniki, Greece