CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Standard diet (SD) +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02092753N/ACompleted
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Ketogenic Or LOGI Diet In a Breast Cancer Rehabilitation Intervention (KOLIBRI)

Universitätsmedizin Mannheim·interventional·Posted Mar 20, 2014·Updated Feb 26, 2016

In Brief

A clinical study evaluating Standard diet (SD), Experimental 1: Ketogenic diet (KD)., and 1 other intervention for Quality of Life. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsQuality of Life
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 20, 2014
Enrollment StartMar 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.3 years ago

Interventions

Standard diet (SD)other

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

Experimental 1: Ketogenic diet (KD).other

Nutritional intervention: recommendations to follow a ketogenic diet

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

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