ClinicalTrials.gg
Status unknownNCT05759689Updated Mar 22, 2023

Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery

An interventional study of Dietary Supplement: Resource Energy and Dietary Supplement: Calogen in Dumping Syndrome and Gastric Surgery, sponsored by Larissa University Hospital. Status unknown at 1 site in Greece. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by Larissa University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Sep 2021, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
30
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
  • Gastric Surgery

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Keywords

  • Dumping syndrome
  • Fat supplement
  • Gastric surgery
03

In context

Dumping Syndrome

20 studies on the registry are indexed under Dumping Syndrome; 3 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 17 interventional studies indexed under Dumping Syndrome.

Browse Dumping Syndrome studies →

Lead sponsor

Larissa University Hospital is the lead sponsor of 41 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or hypoglycemic tablets and Insulin.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

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

Study arms

  • Experimental
    Diagnose Dumping after supplement consumption

    Carbohydrate ingestion to provoke dumping syndrome related symptoms

    Dietary Supplement: Dietary Supplement: Resource Energy · Dietary Supplement: Dietary Supplement: Calogen

  • Active comparator
    Fat supplementation

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

    Dietary Supplement: Dietary Supplement: Resource Energy · Dietary Supplement: Dietary Supplement: Calogen

Interventions

  • Dietary supplementDietary Supplement: Resource Energy

    Carbohydrate Supplement

  • Dietary supplementDietary Supplement: Calogen

    Polyunsaturated liquid fat supplement

06

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

07

Study locations

1 of 1 sites recruiting
  • University Hospital Larissa
    Larissa, 41334, Greece
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05759689
Lead sponsor
Larissa University Hospital
Responsible party
ATHANASIOS MIGDANIS (Research Associate Univeristy of Thessaly, Larissa University Hospital) — Principal investigator
First posted
Mar 8, 2023
Start date
Sep 28, 2021
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Mar 22, 2023

Study contacts

ATHANASIOS MIGDANIS
Contact
thanmig@yahoo.com
6973240203

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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