Protein, Fiber, and Metabolic Syndrome - The PROFIMET Study

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.

Conditions

• Overweight
• Obesity
• Metabolic Syndrome

Interventions

OTHER

control diet, supported by dietary supplement twice daily

control diet, see above

OTHER

high cereal fiber diet, supported by dietary supplement twice daily

high cereal fiber diet, see above

OTHER

high protein diet, supported by dietary supplement twice daily

high protein diet, see above

OTHER

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

MIX diet, see above

Sponsors & Collaborators

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Medical University of Vienna

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University Hospitals Coventry and Warwickshire NHS Trust

  collaborator OTHER

• Coventry University

  collaborator OTHER

• German Institute of Human Nutrition

  lead OTHER

Principal Investigators

• Martin O Weickert, MD · University Hospitals Coventry & Warwickshire; and University of Warwick, UK

• Andreas FH Pfeiffer, Prof · German Institute of Human Nutrition Potsdam-Rehbrücke; Charité-University-Medicine Berlin

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

24 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2010-03-31

Completion

2013-07-31

Countries

• Germany
• United Kingdom

Study Locations