Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI)
Condition: Quality of Life
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Standard diet (SD); Experimental 1: Ketogenic diet (KD).; Experimental 2: "Low glycämic and insulinemic" diet (LOGI)
Intervention type(s): Other; Other; Other
Intervention description(s): Nutrition intervention following the recommendations of the germans society for nutrition (DGE); Nutritional intervention: recommendations to follow a ketogenic diet; Nutritional intervention: patients were instructed to follow the "LOGI" diet regimen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Ketogenic diet, logi diet, breast cancer, rehabilitation