Fat Supplementation on Dumping Syndrome Associated Symptoms

NCT ID: NCT04028193

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2023-04-30

Brief Summary

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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

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Conditions

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Dumping Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diagnose Dumping after supplement consumption

Carbohydrate ingestion to provoke dumping syndrome related symptoms

Group Type OTHER

Resource Energy

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate Supplement

Fat supplementation

A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.

Group Type OTHER

Calogen

Intervention Type DIETARY_SUPPLEMENT

Polyunsaturated liquid fat supplement

Interventions

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Calogen

Polyunsaturated liquid fat supplement

Intervention Type DIETARY_SUPPLEMENT

Resource Energy

Carbohydrate Supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Calogen fat supplement

Eligibility Criteria

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Inclusion Criteria

* Patients with Dumping Syndrome

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technological Educational Institute of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Chatzipapa Nikoleta

Research Associate University of Thessaly

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nikoleta Chatzipapa

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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NIKOLETA CHATZIPAPA

Role: CONTACT

00306982484394

DEMETRA HARITOU

Role: CONTACT

00306973240203

Facility Contacts

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NIKOLETA CHATZIPAPA

Role: primary

DEMETRA HARITOU

Role: backup

Other Identifiers

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5411069DD0467

Identifier Type: -

Identifier Source: org_study_id

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