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The effect of very low carbohydrate and high fat diet on gastric cancer

A clinical trial comparing a very low carbohydrate MCT oil supplemented diet with standard diet on prognostic biomarkers and indicators related to cachexia in gastric adenocarcinoma patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016102830538N1
Enrollment
20
Registered
2016-12-20
Start date
2016-12-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer. Malignant neoplasm of stomach

Interventions

Intervention 1: Intervention group receives an Isocaloric diet with low carbohydrate content. Dietary components will change weekly in order to increase MCT oil consumption. The carbohydrates are limi
Treatment - Other
Intervention group receives an Isocaloric diet with low carbohydrate content. Dietary components will change weekly in order to increase MCT oil consumption. The carbohydrates are limited to 10 to 15%
Patients in the control group are recipients of an Isocaloric standard diet with the normal dietary components based on their dietary requirements.

Sponsors

Vice chancellor of research, International Campus, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (Inclusion criteria: diagnosis of gastric adenocarcinoma; patients with ECOG performance status of 0 to 4; patients who have not been gastrectomized; blood, liver, and kidney should be functional; patients aged 18 years and older; both genders will be recruited; leucocytes count be over 3000 cell in each mm3 of blood; neutrophil count be over 1500 cubic millimeter of blood; platelets be over 1500 per each cubic millimeter of blood; total bilirubin lower than 3mg/dL; serum creatinine lower than 2mg/dL; serum potassium less than 5 mmol/L). (Exclusion criteria: Patients which live alone during the intervention without others attendance; Diabetes; patients receiving Insulin or other anabolic drugs along with intervention; pyruvate dehydrogenase complex deficiency; and inherited porphyria ; MCT oil consumption until 5 weeks before recruitment in study; Having congestive heart failure; Uncontrolled hypertension. Severe steatorrhea and diarrhea; Gastrointestinal obstruction; Patients which could not resist the intervention for any reason; Frequent incidence of hypoglycemia during first week of intervention).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Carcinoembryonic antigen (CEA). Timepoint: Before and after intervention. Method of measurement: ELISA.;Ca19-9. Timepoint: Before and after intervention. Method of measurement: ELISA.;Serum ketone bodies. Timepoint: Before and after intervention. Method of measurement: Spectrophotometer.;FBS. Timepoint: Before and after intervention. Method of measurement: Spectrophotometer.;Body Mass Index (BMI). Timepoint: Before and after intervention. Method of measurement: Formula.;Hs-CRP. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.

Secondary

MeasureTime frame
Insulin. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.;Resting energy expenditure (REE). Timepoint: Before and after intervention. Method of measurement: Gathering the produced CO2 by indirect calorimetry.;HOMA-IR. Timepoint: Before and after intervention. Method of measurement: Is calculated by the formula.;Serum Lactate. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.;CBC-diff. Timepoint: Before and after intervention. Method of measurement: Complete blood count and differential.;Serum Albumin. Timepoint: Before and after intervention. Method of measurement: Auto analyzer.;Karnofsky score. Timepoint: Before and after intervention. Method of measurement: Observation.;Eastern Cooperative Oncology Group (ECOG). Timepoint: Before and after intervention. Method of measurement: Observation.;Bioelectric Impedance Analysis (BIA). Timepoint: Before and after intervention. Method of measurement: Weight.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Dadfarma

School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences

adadfar@razi.tums.ac.ir; alireza.da89@gmail.com+98 21 8895 5975

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026