Protein, Fiber, and Metabolic Syndrome - The PROFIMET Study

NCT00579657 | Completed

• 2 other identifiers: mow_PROFIMETBMBF Profimet 0313826A
• Study Type: interventional
• Target: 111
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

parameters of metabolic syndrome

Outcome Measures

Primary Outcomes (2)

• change in insulin sensitivity

  whole-body insulin sensitivity measured with euglycemic hyperinsulinemic clamp; hepatic insulin sensitivity measured with stable isotope techniques (DD-glucose) during the clamps; relation with secondary outcome measures

  6 weeks

• change in insulin sensitivity

  whole-body insulin sensitivity measured with euglycemic hyperinsulinemic clamp; hepatic insulin sensitivity measured with stable isotope techniques (DD-glucose) during the clamps; relation with secondary outcome measures

  18 weeks

Secondary Outcomes (4)

• factors that may contribute explaining changes in primary outcome measures

  0, 6, 18 weeks

• biomarkers indicating dietary adherence

  0, 6, 18 weeks

• development of indices for the prediction of insulin resistance (liver, whole-body)

  baseline, validation after 6 -18 weeks

• development for indices for the prediction of fat mass (liver, abdominal)

  baseline, validation after 6 -18 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Intervention: 'control diet, supported by dietary supplement twice daily' control diet \[carbohydrates 55(50 - 60)% , protein 15(10 - 20)% protein; fat ca. 30% of energy content; dietary fiber \< 15 g/1000 kcal and day; intensive dietary advice plus supplement (2 x basic supplement daily)\]

Other: control diet, supported by dietary supplement twice daily

2

EXPERIMENTAL

Intervention: 'high cereal fiber diet, supported by dietary supplement twice daily'. high cereal fiber diet \[carbohydrates 55(50 - 60)% , protein 15(10 - 20)% protein; fat ca. 30% of energy content; dietary fiber \> 20 g/1000 kcal and day; intensive dietary advice plus supplement (2 x basic supplement including 2 x 15 g cereal fiber daily)\]

Other: high cereal fiber diet, supported by dietary supplement twice daily

3

EXPERIMENTAL

Intervention: 'high protein diet, supported by dietary supplement twice daily' high protein diet \[carbohydrates 40 - 45% , protein \> 25 - 30%; fat ca. 30% of energy content; dietary fiber \< 15 g/1000 kcal and day; intensive dietary advice plus supplement (2 x basic supplement including 2 x 25 g whey and plant protein daily)\]

Other: high protein diet, supported by dietary supplement twice daily

4

EXPERIMENTAL

Intervention: "diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily". high cereal fiber/high protein (MIX) moderately high cereal fiber/high protein diet (carbohydrates 45- 50)% , protein 20 - 25%; fat ca. 30% of energy content; dietary fiber 15 - 20 g/1000 kcal and day; intensive dietary advice plus supplement (2 x basic supplement including 2 x 15 g cereal fiber and 2 x 25 g whey and plant protein daily)

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

Interventions

control diet, supported by dietary supplement twice daily OTHER

control diet, see above

1

high cereal fiber diet, supported by dietary supplement twice daily OTHER

high cereal fiber diet, see above

2

high protein diet, supported by dietary supplement twice daily OTHER

high protein diet, see above

3

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

MIX diet, see above

4

Eligibility Criteria

• Age: 24 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waist \> 80 cm (females) or \> 94 cm (males)
• BMI \> 25 kg/m²
• IFG, IGT, or insulin resistance; and/or dyslipidemia; and/or high blood pressure
• Willingness to comply with one of the randomly assigned diets over the study period

You may not qualify if:

• Diabetes type 1 and type 2
• Pregnancy
• Allergies including food allergies
• Metal implants
• Chronic disease of heart, kidney, or liver
• Relevant deviation of body weight during isoenergetic 6-weeks period (+/- 3 kg)
• Intake of drugs with known impact on whole-body insulin sensitivity during the study (e.g. cortisone, ASS, antibiotics)
• Missing data about primary outcome measures (Clamp data, data about dietary intake from food diaries or 3-day food protocols)
• Significant deviation from dietary targets during the monitored 6 weeks isoenergetic period (e.g. significant deviation from 30% target for dietary fat in all groups, intake of a low protein or low fiber diet in the high protein or high fiber groups, respectively)

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• German Federal Ministry of Education and Research: collaborator
• Medical University of Vienna: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator
• University Hospital Tuebingen: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• Coventry University: collaborator

Study Sites (4)

Deutsches Diabetes Zentrum; Heinrich Heine University

Düsseldorf, Germany

Location

Diagnostic and Interventional Radiology, Klinikum Ernst von Bergmann, Academic Teaching Hospital, Charité University Medicine Berlin

Potsdam, Germany

Location

Eberhard-Karls University Tübingen, Section on Experimental Radiology, Department of Diagnostic and Interventional Radiology

Tübingen, Germany

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Related Publications (12)

• Gogebakan O, Kohl A, Osterhoff MA, van Baak MA, Jebb SA, Papadaki A, Martinez JA, Handjieva-Darlenska T, Hlavaty P, Weickert MO, Holst C, Saris WH, Astrup A, Pfeiffer AF; DiOGenes. Effects of weight loss and long-term weight maintenance with diets varying in protein and glycemic index on cardiovascular risk factors: the diet, obesity, and genes (DiOGenes) study: a randomized, controlled trial. Circulation. 2011 Dec 20;124(25):2829-38. doi: 10.1161/CIRCULATIONAHA.111.033274. Epub 2011 Nov 21.

  PMID: 22104550 BACKGROUND

• Isken F, Klaus S, Osterhoff M, Pfeiffer AF, Weickert MO. Effects of long-term soluble vs. insoluble dietary fiber intake on high-fat diet-induced obesity in C57BL/6J mice. J Nutr Biochem. 2010 Apr;21(4):278-84. doi: 10.1016/j.jnutbio.2008.12.012. Epub 2009 Apr 14.

  PMID: 19369060 BACKGROUND

• Weickert MO, Pfeiffer AF. Low-glycemic index vs high-cereal fiber diet in type 2 diabetes. JAMA. 2009 Apr 15;301(15):1538; author reply 1538-9. doi: 10.1001/jama.2009.483. No abstract available.

  PMID: 19366767 BACKGROUND

• Weickert MO, Pfeiffer AF. Metabolic effects of dietary fiber consumption and prevention of diabetes. J Nutr. 2008 Mar;138(3):439-42. doi: 10.1093/jn/138.3.439.

  PMID: 18287346 BACKGROUND

• Weickert MO, Mohlig M, Schofl C, Arafat AM, Otto B, Viehoff H, Koebnick C, Kohl A, Spranger J, Pfeiffer AF. Cereal fiber improves whole-body insulin sensitivity in overweight and obese women. Diabetes Care. 2006 Apr;29(4):775-80. doi: 10.2337/diacare.29.04.06.dc05-2374.

  PMID: 16567814 BACKGROUND

• Weickert MO, Mohlig M, Koebnick C, Holst JJ, Namsolleck P, Ristow M, Osterhoff M, Rochlitz H, Rudovich N, Spranger J, Pfeiffer AF. Impact of cereal fibre on glucose-regulating factors. Diabetologia. 2005 Nov;48(11):2343-53. doi: 10.1007/s00125-005-1941-x. Epub 2005 Sep 20.

  PMID: 16172868 BACKGROUND

• Weickert MO, Roden M, Isken F, Hoffmann D, Nowotny P, Osterhoff M, Blaut M, Alpert C, Gogebakan O, Bumke-Vogt C, Mueller F, Machann J, Barber TM, Petzke KJ, Hierholzer J, Hornemann S, Kruse M, Illner AK, Kohl A, Loeffelholz CV, Arafat AM, Mohlig M, Pfeiffer AF. Effects of supplemented isoenergetic diets differing in cereal fiber and protein content on insulin sensitivity in overweight humans. Am J Clin Nutr. 2011 Aug;94(2):459-71. doi: 10.3945/ajcn.110.004374. Epub 2011 Jun 1.

  PMID: 21633074 RESULT

• Weickert MO, Arafat AM, Blaut M, Alpert C, Becker N, Leupelt V, Rudovich N, Mohlig M, Pfeiffer AF. Changes in dominant groups of the gut microbiota do not explain cereal-fiber induced improvement of whole-body insulin sensitivity. Nutr Metab (Lond). 2011 Dec 17;8:90. doi: 10.1186/1743-7075-8-90.

  PMID: 22177085 RESULT

• Hattersley JG, Mohlig M, Roden M, Arafat AM, Loeffelholz CV, Nowotny P, Machann J, Hierholzer J, Osterhoff M, Khan M, Pfeiffer AF, Weickert MO. Quantifying the improvement of surrogate indices of hepatic insulin resistance using complex measurement techniques. PLoS One. 2012;7(6):e39029. doi: 10.1371/journal.pone.0039029. Epub 2012 Jun 22.

  PMID: 22761721 RESULT

• Weickert MO. What dietary modification best improves insulin sensitivity and why? Clin Endocrinol (Oxf). 2012 Oct;77(4):508-12. doi: 10.1111/j.1365-2265.2012.04450.x.

  PMID: 22640465 RESULT

• Hattersley JG, Pfeiffer AF, Roden M, Petzke KJ, Hoffmann D, Rudovich NN, Randeva HS, Vatish M, Osterhoff M, Goegebakan O, Hornemann S, Nowotny P, Machann J, Hierholzer J, von Loeffelholz C, Mohlig M, Arafat AM, Weickert MO. Modulation of amino acid metabolic signatures by supplemented isoenergetic diets differing in protein and cereal fiber content. J Clin Endocrinol Metab. 2014 Dec;99(12):E2599-609. doi: 10.1210/jc.2014-2302.

  PMID: 25157543 RESULT

• Cuthbertson DJ, Weickert MO, Lythgoe D, Sprung VS, Dobson R, Shoajee-Moradie F, Umpleby M, Pfeiffer AF, Thomas EL, Bell JD, Jones H, Kemp GJ. External validation of the fatty liver index and lipid accumulation product indices, using 1H-magnetic resonance spectroscopy, to identify hepatic steatosis in healthy controls and obese, insulin-resistant individuals. Eur J Endocrinol. 2014 Nov;171(5):561-9. doi: 10.1530/EJE-14-0112.

  PMID: 25298375 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome

Interventions

Diet, High-Protein; Proteins

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Amino Acids, Peptides, and Proteins

Study Officials

• Martin O Weickert, MD

  University Hospitals Coventry & Warwickshire; and University of Warwick, UK

  STUDY CHAIR

• Andreas FH Pfeiffer, Prof

  German Institute of Human Nutrition Potsdam-Rehbrücke; Charité-University-Medicine Berlin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study PI

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 24, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2013
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

GB (1); DE (3)