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

Quality of Life Clinical Trial

— KOLIBRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092753
• Other study ID #: KOLIBRI
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: February 25, 2016
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Quality of Life

Intervention

Other:
• Standard diet (SD)
Nutrition intervention following the recommendations of the germans society for nutrition (DGE)
• Experimental 1: Ketogenic diet (KD).
Nutritional intervention: recommendations to follow a ketogenic diet
• Experimental 2: "Low glycämic and insulinemic" diet (LOGI)
Nutritional intervention: patients were instructed to follow the "LOGI" diet regimen

Locations

Country	Name	City	State
Germany	Rehaklinik Am Kurpark	Bad Kissingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (12)

Chu-Shore CJ, Thiele EA. Tumor growth in patients with tuberous sclerosis complex on the ketogenic diet. Brain Dev. 2010 Apr;32(4):318-22. doi: 10.1016/j.braindev.2009.04.009. Epub 2009 May 13. — View Citation

Fine EJ, Segal-Isaacson CJ, Feinman RD, Herszkopf S, Romano MC, Tomuta N, Bontempo AF, Negassa A, Sparano JA. Targeting insulin inhibition as a metabolic therapy in advanced cancer: a pilot safety and feasibility dietary trial in 10 patients. Nutrition. 2012 Oct;28(10):1028-35. doi: 10.1016/j.nut.2012.05.001. Epub 2012 Jul 26. — View Citation

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

Klement RJ, Kämmerer U. Is there a role for carbohydrate restriction in the treatment and prevention of cancer? Nutr Metab (Lond). 2011 Oct 26;8:75. doi: 10.1186/1743-7075-8-75. — View Citation

Kossoff EH, Borsage JL, Comi AM. A pilot study of the modified Atkins diet for Sturge-Weber syndrome. Epilepsy Res. 2010 Dec;92(2-3):240-3. doi: 10.1016/j.eplepsyres.2010.09.008. Epub 2010 Oct 8. — View Citation

Kossoff EH, Hartman AL. Ketogenic diets: new advances for metabolism-based therapies. Curr Opin Neurol. 2012 Apr;25(2):173-8. doi: 10.1097/WCO.0b013e3283515e4a. Review. — View Citation

Kossoff EH, Turner Z, Bergey GK. Home-guided use of the ketogenic diet in a patient for more than 20 years. Pediatr Neurol. 2007 Jun;36(6):424-5. — View Citation

Masko EM, Thomas JA 2nd, Antonelli JA, Lloyd JC, Phillips TE, Poulton SH, Dewhirst MW, Pizzo SV, Freedland SJ. Low-carbohydrate diets and prostate cancer: how low is "low enough"? Cancer Prev Res (Phila). 2010 Sep;3(9):1124-31. doi: 10.1158/1940-6207.CAPR-10-0071. Epub 2010 Aug 17. — View Citation

Schmidt M, Pfetzer N, Schwab M, Strauss I, Kämmerer U. Effects of a ketogenic diet on the quality of life in 16 patients with advanced cancer: A pilot trial. Nutr Metab (Lond). 2011 Jul 27;8(1):54. doi: 10.1186/1743-7075-8-54. — View Citation

Seyfried BT, Kiebish M, Marsh J, Mukherjee P. Targeting energy metabolism in brain cancer through calorie restriction and the ketogenic diet. J Cancer Res Ther. 2009 Sep;5 Suppl 1:S7-15. doi: 10.4103/0973-1482.55134. Review. — View Citation

Seyfried TN, Marsh J, Shelton LM, Huysentruyt LC, Mukherjee P. Is the restricted ketogenic diet a viable alternative to the standard of care for managing malignant brain cancer? Epilepsy Res. 2012 Jul;100(3):310-26. doi: 10.1016/j.eplepsyres.2011.06.017. Epub 2011 Aug 31. Review. — View Citation

Woolf EC, Scheck AC. The ketogenic diet for the treatment of malignant glioma. J Lipid Res. 2015 Jan;56(1):5-10. doi: 10.1194/jlr.R046797. Epub 2014 Feb 6. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	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.	No
Secondary	Safety	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)	Yes
Secondary	Tolerability	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	No

External Links

•   Hompage of the clinic in which the study is about to be accomplished.