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Status unknownNCT04028193Fat on DSUpdated Nov 15, 2022

Fat Supplementation on Dumping Syndrome Associated Symptoms

An interventional study of Calogen and Resource Energy in Dumping Syndrome, sponsored by Technological Educational Institute of Thessaly. Status unknown at 1 site in Greece. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Technological Educational Institute of Thessaly · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Dumping Syndrome

Keywords

  • Dumping syndrome
  • Fat supplement
  • post bariatric surgery
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with Dumping Syndrome

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Other
    Diagnose Dumping after supplement consumption

    Carbohydrate ingestion to provoke dumping syndrome related symptoms

    Dietary Supplement: Resource Energy

  • Other
    Fat supplementation

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

    Dietary Supplement: Calogen

Interventions

  • Dietary supplementCalogen

    Polyunsaturated liquid fat supplement

    Also known as: Calogen fat supplement

  • Dietary supplementResource Energy

    Carbohydrate Supplement

05

What researchers measure

Primary outcomes

  1. Glucose Levels

    Blood glucose measurement

    Time frame: before the ingestion of the carbohydrate and fat supplement (baseline)

  2. Glucose Levels

    Blood glucose measurement

    Time frame: 30 minutes after the ingestion of the carbohydrate and fat supplement

  3. Glucose Levels

    Blood glucose measurement

    Time frame: 60 minutes after the ingestion of the the carbohydrate and fat supplement

  4. Glucose Levels

    Blood glucose measurement

    Time frame: 90 minutes after the ingestion of the the carbohydrate and fat supplement

  5. Glucose Levels

    Blood glucose measurement

    Time frame: 120 minutes after the ingestion of the the carbohydrate and fat supplement

  6. Sigstad's Questionnaire

    Dumping syndrome symptom associated questionnaire

    Time frame: 1st hour after the ingestion of the supplements

  7. Sigstad's Questionnaire

    Dumping syndrome symptom associated questionnaire

    Time frame: 2nd hour after the ingestion of the supplements

  8. Arts's Questionnaire

    Dumping syndrome symptom associated questionnaire

    Time frame: 1st hour after the ingestion of the supplements

  9. Arts's Questionnaire

    Dumping syndrome symptom associated questionnaire

    Time frame: 2nd hour after the ingestion of the supplements

06

Study locations

1 of 1 sites recruiting
  • Nikoleta Chatzipapa
    Thessaloniki, 56533, Greece
    Recruiting
07

Registry details

Key details

Study ID
NCT04028193
Lead sponsor
Technological Educational Institute of Thessaly
Responsible party
Chatzipapa Nikoleta (Research Associate University of Thessaly, University of Thessaly) — Principal investigator
First posted
Jul 22, 2019
Start date
Sep 12, 2017
Primary completion
Dec 2022 (estimated)
Completion
Apr 2023 (estimated)
Last update
Nov 15, 2022

Study contacts

NIKOLETA CHATZIPAPA
Contact
nikoletaxatzhpapa@hotmail.com
00306982484394
DEMETRA HARITOU
Contact
dharitou@yahoo.gr
00306973240203

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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