CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
control diet, supported by dietary supplement twice daily +3 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.

Search/NCT00579657
NCT00579657N/ACompleted
CompareCT.gov

Effects of High Protein and High Cereal Fiber Diets on Insulin Sensitivity in Overweight and Obese Subjects With the Metabolic Syndrome - The PROFIMET Study

German Institute of Human Nutrition·interventional·Posted Dec 24, 2007·Updated Mar 8, 2016

In Brief

A clinical study evaluating control diet, supported by dietary supplement twice daily, high cereal fiber diet, supported by dietary supplement twice daily, and 2 other interventions for Overweight and 2 related conditions. Completed, enrolled 111 participants across 4 sites in 2 countries.

Detailed Summary

Randomized controlled single-blinded intervention study in 111 overweight and obese subjects with risk factors of developing type 2 diabetes, with the aim to investigate effects of isoenergetic high cereal fiber as compared with high protein diets over 6 and 18 weeks. Proof of principle study with analysis according to study protocol, investigating whether isoenergetic high cereal fiber and high protein diets with comparable fat contents, if adhered to and after exclusion of known confounders such as changes in body weight, intake of drugs with known effects on insulin sensitivity, or relevant changes in physical activity, indeed affect insulin sensitivity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity, Metabolic Syndrome
CountriesGermany, United Kingdom
CollaboratorsGerman Federal Ministry of Education and Research, Medical University of Vienna, Heinrich-Heine University, Duesseldorf, University Hospital Tuebingen, Charite University, Berlin, Germany, University Hospitals Coventry and Warwickshire NHS Trust, Coventry University

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2007
Enrollment StartAug 1, 2007
Primary CompletionMar 1, 2010
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.5 years ago

Interventions

control diet, supported by dietary supplement twice dailyother

control diet, see above

high cereal fiber diet, supported by dietary supplement twice dailyother

high cereal fiber diet, see above

high protein diet, supported by dietary supplement twice dailyother

high protein diet, see above

diet moderately high both in cereal fiber and protein, supported by dietary supplement twice dailyother

MIX diet, see above