Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI) (KOLIBRI)

February 25, 2016 updated by: Marc Sütterlin, MD, PhD, Universitätsmedizin Mannheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Bad Kissingen, Baden-Württemberg, Germany, 97688
        • Rehaklinik Am Kurpark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
see below (description)
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]
see below

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOLIBRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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