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Trial record 1 of 3 for:    "breast cancer" "ketogenic diet"
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Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI) (KOLIBRI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02092753
First Posted: March 20, 2014
Last Update Posted: February 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marc Sütterlin, MD, PhD, Universitätsmedizin Mannheim
  Purpose

The aim of the study is to analyze if a ketogenic diet (KD) compared to either a "low glycämic and insulinemic" (LOGI) diet or to a standard diet (SD) is feasible, safe and tolerable and will improve quality of life and physical performance in patients with Breast Cancer during the rehabilitation phase.

It will be an open-label trial of nutritional intervention for 20 weeks spanning three phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of stationary intervention.


Condition Intervention
Quality of Life Other: Standard diet (SD) Other: Experimental 1: Ketogenic diet (KD). Other: Experimental 2: "Low glycämic and insulinemic" diet (LOGI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI)

Resource links provided by NLM:


Further study details as provided by Marc Sütterlin, MD, PhD, Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Quality of life [ Time Frame: It will be an open-label trial of nutritional intervention for 20 weeks spanning three phases: 3 weeks of stationary intervention, 16 weeks of outhouse phase and one final week of stationary intervention. ]

    To study the effect of a ketogenic diet (KD) or a low glycämic and insulinemic diet (LOGI) compared to a standard diet (SD) on quality of life in patients with Breast Cancer during the rehabilitation phase.

    This will be done by comparing the results of the EORTC QLQ-30 and the QLQ-BR23 questionnaires.



Secondary Outcome Measures:
  • Safety [ Time Frame: see below (description) ]

    For all patients in the three groups (KD, LOGI and SD ) in parallel:

    Feasibility measured as average calorie and carbohydrate intake per day during weeks 1-20 as documented by food diary at one random day/week Safety as defined as number of patients with adverse events [ Time Frame: weeks 1-20] Ketosis as dokumented daily in urine and blood [Time Frame: days 1-21] and in urine daily [Time Frame: week 4-20) Physical performance as obtained by spiroergometry [Time frame: day 1, day 21 and week 20] Body composition as analyzed by standard-Bioimpedance analysis(BIA), Dual- measurement [Time frame: day 1, 21 and week 20] Metabolic parameters (triglycerides, cholesterine, glucose, insulin, IGF-1) in patients serum via standard laboratory procedure [Time frame: day 1, 21, week 11 and 20]


  • Tolerability [ Time Frame: see below ]

    For all patients in the three groups (KD, LOGI and SD ) in parallel:

    Feasibility measured as average calorie and carbohydrate intake per day during weeks 1-20 as documented by food diary at one random day/week tolerability as defined as number of patients with adverse events [ Time Frame: weeks 1-20] Ketosis as dokumented daily in urine and blood [Time Frame: days 1-21] and in urine daily [Time Frame: week 4-20) Physical performance as obtained by spiroergometry [Time frame: day 1, day 21 and week 20] Body composition as analyzed by standard-Bioimpedance analysis(BIA), Dual- measurement [Time frame: day 1, 21 and week 20] Metabolic parameters (triglycerides, cholesterine, glucose, insulin, IGF-1) in patients serum via standard laboratory procedure [Time frame: day 1, 21, week 11 and 20]



Enrollment: 150
Study Start Date: March 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard diet
Standard diet (SD): Nutrition following the standard recommendations of the German society for nutrition
Other: Standard diet (SD)
Nutrition intervention following the recommendations of the germans society for nutrition (DGE)
Experimental: Ketogenic diet

Nutritional intervention: Ketogenic diet (KD).

Intervention: Nutritional support (hospital) + self support (outpatient phase) with KD

Other: Experimental 1: Ketogenic diet (KD).
Nutritional intervention: recommendations to follow a ketogenic diet
Experimental: Logi diet

Nutritional intervention: low glycämic and insulinemic" diet (LOGI)

Intervention: Nutritional support (hospital) + self support (outpatient phase) with LOGI

Other: Experimental 2: "Low glycämic and insulinemic" diet (LOGI)
Nutritional intervention: patients were instructed to follow the "LOGI" diet regimen

Detailed Description:

Cancer patient's whole body metabolism is characterized by an increased fat oxidation rate and a decrease ability to metabolize glucose for energy demands (insulin resistance). In preliminary studies it was shown, that a fat rich diet allows to spare muscle mass from being reduced due to catabolic mechanisms. The resulting better body composition relates to less fatigue and higher quality of life, the latter was shown in advanced cancer patients for a ketogenic diet.

The aim of the KOLIBRI-study is to analyze if a very fat rich ketogenic diet (KD) or a moderate fat rich "low glycämic and insulinemic" (LOGI) diet compared to a standard low fat diet (SD) are feasible, safe and tolerable and will improve quality of life and physical performance in patients with Breast Cancer during the rehabilitation phase.

The most stringent nutritional regime high in fat and low in carbohydrates is the ketogenic diet (KD) comprised of at least 75% of daily calories via fat (derived from several plant oils, nuts, avocado, butter, cream, cheese, eggs, fatty fish and fat rich meat), balanced in protein (1.4 g/kg body weight/day) and very low in carbohydrates (approx. 20-30 grams per day, derived from salad, vegetable, some berries or fruits, and milk products like yoghurt).

A less strict but even lower in carbohydrates and richer in fat and protein than a standard diet is the LOGI regimen. It allows up to 120 grams of carbohydrates (inclusion of more vegetable and fruit and rare grains and potatoes compared to KD), is high in protein (1.7 g/kg body weight/day) and rich in fat (remaining calories) The control nutritional regime follows the standard recommendations of the German society for nutrition (DGE) and is comprised of at least 50% of the daily energy derived from carbohydrates, 0.8 grams/kg of body weight protein and 30% of daily energy expenditure from fat.

It will be an open-label trial of nutritional intervention for 20 weeks spanning three phases:

The first phase spans 3 weeks of stationary intervention in a hospital (location: Bad Kissingen, Bavaria, Germany) with the initial examination (medical, body composition, food preferences, quality of life, blood samples, physical performance) followed by implementation of the allocated diet and respective training of the patients in diet calculation, cooking and realization of the diet regimen in routine daily life.

The second phase encompasses16 weeks of an outhouse phase with continuing the selected nutritional regime under close contact and supervision of the study team accompanied by urine measurements (KD group), food diaries, questionnaires covering the quality of life and one blood sample) The third phase of the study represents one week of stationary intervention at the hospital with the final examination and further teaching in eiterh sticking to the selected diet or in changing the diet to the individually preferred one.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Consenting women aged 18 - 70 years.
  2. Primary or recurrent breast cancer after primary standard therapy during the standard rehabilitation phase
  3. Karnofsky Index >70.
  4. Willing and being able to follow the allocated dietary regime for 20 weeks

Exclusion Criteria:

  1. Patients with additional malignant tumors at the time of the recruitment
  2. Participation at other trials
  3. Dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
  4. Not able to follow the teaching due to deficits in teaching language (German)
  5. Metabolic aberration banning fat rich nutrition or were a KD is contraindicated
  6. Expected life span < 12 month
  7. Insulin dependent Diabetes
  8. Decompensated heart failure (NYHA > 2)
  9. Myocardial infarction within the last 6 months, symptomatic atrial fibrillation
  10. Severe acute infection
  11. Pregnancy
  12. Pancreatic insufficiency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092753


Locations
Germany
Rehaklinik Am Kurpark
Bad Kissingen, Baden-Württemberg, Germany, 97688
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Study Chair: Marc Sütterlin, MD, Prof. Department of Obstetrics and Gynecology, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany
Study Director: Monika Reuss-Borst, MD, Prof. Rehaklinik Am Kurpark, Bad Kissingen, Germany
  More Information

Additional Information:
Publications:
Klement RJ, Frobel T, Albers T, Fikenzer S, Prinzhausen J, Kämmerer U. A pilot case study on the impact of a self-prescribed ketogenic diet on biochemical parameters and running performance in healthy and physically active individuals. NuMe 2013; 1(1):1-32

Responsible Party: Marc Sütterlin, MD, PhD, MD, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02092753     History of Changes
Other Study ID Numbers: KOLIBRI
First Submitted: February 26, 2014
First Posted: March 20, 2014
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by Marc Sütterlin, MD, PhD, Universitätsmedizin Mannheim:
Ketogenic diet, logi diet, breast cancer, rehabilitation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases