Ketogenic diet along with high-dose ascorbic acid in triple-negative breast cancer

Effect of a medium-chain triglyceride (MCT)-Based Ketogenic Dietary Intervention along with high-dose intravenous ascorbic acid among overweight/obese patients with triple-negative breast cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161022030424N11

Enrollment

240

Registered

2024-08-06

Start date

2024-08-22

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Triple negative breast cancer. Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group 1: A medium-chain triglyceride-based ketogenic diet [6% of daily energy intake from carbohydrates, 19% from protein, 20% from medium-chain triglyceride, and 55% from

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 18 to 70 years old Pathologically confirmed early-stage triple-negative breast cancer subtype 1–3 positive axillary lymph nodes Histological grades I-III Unilateral cancer A body mass index (BMI) of 25 kg/m2 and higher

Exclusion criteria

Exclusion criteria: Serious cardiovascular disease Pregnancy Cognitive impairment Metabolic defects as a contraindication against ketogenic diet Who are considered unsuitable for the trial by the principal investigator because of abnormal blood indices or other reasons Use of systemic corticosteroids within one week of trial entry Receipt of chemotherapy within two week of trial entry Prior monoclonal antibody therapy within 1 month of trial entry

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: Weight measurement at the beginning of the study (before the intervention) and the final week of radiotherapy. Method of measurement: InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea).;Lean body mass. Timepoint: Lean body mass measurement at the beginning of the study (before the intervention) and the final week of radiotherapy. Method of measurement: InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea).;Total body fat mass. Timepoint: Total body fat mass measurement at the beginning of the study (before the intervention) and the final week of radiotherapy. Method of measurement: InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea).	—

Measure

Time frame

Weight. Timepoint: Weight measurement at the beginning of the study (before the intervention) and the final week of radiotherapy. Method of measurement: InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea).;Lean body mass. Timepoint: Lean body mass measurement at the beginning of the study (before the intervention) and the final week of radiotherapy. Method of measurement: InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea).;Total body fat mass. Timepoint: Total body fat mass measurement at the beginning of the study (before the intervention) and the final week of radiotherapy. Method of measurement: InBody 720 Body Composition Analyzer 2004; Biospace Co., Ltd., Seoul, Korea).

—

Secondary

Measure	Time frame
Leptin. Timepoint: Serum leptin measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Free fatty acids. Timepoint: Serum free fatty acids measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Fasting blood glucose. Timepoint: Serum fasting blood glucose measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Insulin. Timepoint: Serum insulin measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;High-sensitivity C-reactive protein. Timepoint: Serum high-sensitivity C-reactive protein measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Total antioxidant capacity. Timepoint: Serum total antioxidant capacity measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Malondialdehyde. Timepoint: Serum malondialdehyde measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Fatigue. Timepoint: Fatigue measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Brief Fatigue Inventory.;Depression. Timepoint: Depression measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Beck depression inventory-second edition.;Anxiety. Timepoint: Anxiety measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: State-Trait Anxiety Inventory.;Quality of life. Timepoint	—

Measure

Time frame

Leptin. Timepoint: Serum leptin measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Free fatty acids. Timepoint: Serum free fatty acids measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Fasting blood glucose. Timepoint: Serum fasting blood glucose measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Insulin. Timepoint: Serum insulin measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;High-sensitivity C-reactive protein. Timepoint: Serum high-sensitivity C-reactive protein measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Total antioxidant capacity. Timepoint: Serum total antioxidant capacity measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Malondialdehyde. Timepoint: Serum malondialdehyde measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Biochemical analysis.;Fatigue. Timepoint: Fatigue measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Brief Fatigue Inventory.;Depression. Timepoint: Depression measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: Beck depression inventory-second edition.;Anxiety. Timepoint: Anxiety measurement at the beginning of the study (before the intervention) and the end of the intervention. Method of measurement: State-Trait Anxiety Inventory.;Quality of life. Timepoint

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

neda_dolatkhah@yahoo.com+98 41 3336 1928

Outcome results

None listed

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