The effect of intermittent ketogenic diets on weight loss and markers of breast cancer risk

The acceptability and efficacy of intermittent ketogenic diets for weight loss and their effects on biomarkers of breast cancer risk

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52913838

Enrollment

114

Registered

2012-07-31

Start date

2009-09-14

Completion date

Unknown

Last updated

2023-09-26

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

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

114 subjects will be randomised to one of three diet groups for 3 months weight loss followed by 1 month weight loss maintenance: Group 1: Restricted ketogenic diet (RK) (<40g carboh

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women 2. Family history of breast cancer (lifetime risk >1 in 6) 3. Pre, post or perimenopausal any age 4. Weight gain since age of 20 > 7 kg 5. Body mass index 24?45 kg/ m2 and / or body fat > 30% 6. Able to record diet diaries

Exclusion criteria

Exclusion criteria: 1. Already successfully losing weight 2. Pregnant or planning pregnancy over next few months 3. Eating disorder, depression or alcoholism 4. Co-morbidity which affects weight or ability to exercise (i.e. diabetes, CV, respiratory, musculoskeletal, or thyroid disease) 5. Previous history of cancer

Design outcomes

Primary

Measure	Time frame
1. Insulin sensitivity from fasting insulin (electrochemiluminescence immunoassay), and glucose (hexokinase/G6PD method) using homeostasis model assessment (HOMA) and Glycosylated hemoglobin (HbA1C) (baseline and 3 months only) 2. Body mass and composition: fat free mass and total fat mass (Bioelectrical impedance: Tanita MC-180) waist and hip and bust circumferences 3. Retention to the energy restriction programmes	—

Measure

Time frame

1. Insulin sensitivity from fasting insulin (electrochemiluminescence immunoassay), and glucose (hexokinase/G6PD method) using homeostasis model assessment (HOMA) and Glycosylated hemoglobin (HbA1C) (baseline and 3 months only) 2. Body mass and composition: fat free mass and total fat mass (Bioelectrical impedance: Tanita MC-180) waist and hip and bust circumferences 3. Retention to the energy restriction programmes

—

Secondary

Measure	Time frame
1. Plasma leptin (enzyme immunoassay) 2. Serum IGF-1, adiponectin, triglycerides, high density lipoprotein (HDL), and low density lipoprotein (LDL) cholesterol 3. Ketones in serum and urine 4. Inflammatory markers: Tumor necrosis factor (TNF), Interlukin (IL)-6 5. Markers of oxidative stress; advanced oxidation protein products (AOPP) 6. Intake of energy, fat, protein and carbohydrate (7-day food diary) ( Dietplan) 7. Activity - 7 day activity diary 8. Profile of mood states questionnaire 9. Hunger and appetite visual analogue scales 10. Any adverse effects associated with the programmes e.g. headaches, constipation, fatigue, cramp, sleep pattern disturbance 11. Resting systolic and diastolic blood pressure 12. Menstrual cycle length for premenopausal women not taking contraceptives	—

Measure

Time frame

1. Plasma leptin (enzyme immunoassay) 2. Serum IGF-1, adiponectin, triglycerides, high density lipoprotein (HDL), and low density lipoprotein (LDL) cholesterol 3. Ketones in serum and urine 4. Inflammatory markers: Tumor necrosis factor (TNF), Interlukin (IL)-6 5. Markers of oxidative stress; advanced oxidation protein products (AOPP) 6. Intake of energy, fat, protein and carbohydrate (7-day food diary) ( Dietplan) 7. Activity - 7 day activity diary 8. Profile of mood states questionnaire 9. Hunger and appetite visual analogue scales 10. Any adverse effects associated with the programmes e.g. headaches, constipation, fatigue, cramp, sleep pattern disturbance 11. Resting systolic and diastolic blood pressure 12. Menstrual cycle length for premenopausal women not taking contraceptives

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026