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

NCT02092753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-02-26

No results posted yet for this study

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.

Conditions

  • Quality of Life

Interventions

OTHER

Standard diet (SD)

Nutrition intervention following the recommendations of the germans society for nutrition (DGE)

OTHER

Experimental 1: Ketogenic diet (KD).

Nutritional intervention: recommendations to follow a ketogenic diet

OTHER

Experimental 2: "Low glycämic and insulinemic" diet (LOGI)

Nutritional intervention: patients were instructed to follow the "LOGI" diet regimen

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Marc Sütterlin, MD, Prof. · Department of Obstetrics and Gynecology, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany

  • Monika Reuss-Borst, MD, Prof. · Rehaklinik Am Kurpark, Bad Kissingen, Germany

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092753 on ClinicalTrials.gov