OverweightPROFIMETNCT00579657
Protein, Fiber, and Metabolic Syndrome - The PROFIMET Study
A study testing high cereal fiber diet, supported by dietary supplement twice daily, high protein diet, supported by dietary supplement twice daily and diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily in people with Overweight and Obesity, run by German Institute of Human Nutrition at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Metabolic Syndrome
- What is being tested?
- high cereal fiber diet, supported by dietary supplement twice daily, high protein diet, supported by dietary supplement twice daily and diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2007to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Deutsches Diabetes Zentrum; Heinrich Heine University
Düsseldorf
Diagnostic and Interventional Radiology, Klinikum Ernst von Bergmann, Academic Teaching Hospital, Charité University Medicine Berlin
Potsdam
Eberhard-Karls University Tübingen, Section on Experimental Radiology, Department of Diagnostic and Interventional Radiology
Tübingen
United Kingdom1 site
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, Warwickshire, CV2 2DX
About this study
Official title: Effects of High Protein and High Cereal Fiber Diets on Insulin Sensitivity in Overweight and Obese Subjects With the Metabolic Syndrome - The PROFIMET Study
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.
Read the detailed description
This is a 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 versus high protein diets over 6 and 18 weeks. We also investigate effects of a combined high-cereal-fiber/high-protein (mix) diet, and effects in a control group. All diets are based on foods from plants and whey products commonly assumed to be healthy. This trial is designed as a proof of principle study focusing on participants that are likely to adhere to the respective isoenergetic diets, in order to show whether high protein versus high cereal fiber diets indeed affect insulin sensitivity, as indicated by epidemiological observations. Study participants will receive intensive and regular nutritional advice in order to achieve the respective dietary targets. Dietary adherence of the participants will be supported by providing tailored dietary supplements in all four groups, twice daily over 18 weeks. Supplements are provided for twice daily consumption for all participants in all four dietary intervention groups, throughout the 18-wk intervention (each of the participants will be instructed to consume a total 252 portions of tailored supplements during the intervention, which will handed to the participants in sealed single portions at weeks 0, 3, 6 and 12, totalling 63 portions at each occasion). The packaging of the sealed portions for the 4 intervention arms do not indicate the type of dietary intervention for the participant, but are coded for identification by the supplier. Energy contents of the supplements are considered when calculating individual energy intake. Supplements have been specifically designed for this intervention study, in order to facilitate achieving dietary targets. A 6 week strictly controlled isoenergetic study period (regular group and individual sessions, daily food diaries/FFQs over the first 6 weeks with adaptation of food intake, if necessary, as indicated by direct analysis of FFQs and food protocols, and by weighing the participants; 3-day food protocols at weeks 0, 6, 12, and 18; various biomarkers of dietary adherence) will be followed by a further 12 week ad libitum period, with ongoing intake of the respective diet including the supplements, but no further dietary advice. The primary outcome measure is the detection of diet-induced changes in insulin sensitivity during weight maintaining isoenergetic conditions. Secondary outcomes are changes in factors that may explain potential diet-induced alterations of insulin sensitivity. During the 12-weeks ad libitum period we will further investigate potential effects of the respective diet on changes in body weight, body composition and biomarkers related to energy intake. Participants will be re-invited for anthropometric measurements and measurement of biomarkers in blood (18 weeks after completion of the study), as well as for taking a second muscle tissue biopsy (subset of participants that agreed to this procedure).
- Conditions
- Overweight, Obesity, Metabolic Syndrome
- Being tested
- control diet, supported by dietary supplement twice daily, high cereal fiber diet, supported by dietary supplement twice daily, high protein diet, supported by dietary supplement twice daily, diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily
- Keywords
- parameters of metabolic syndrome
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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)] Receives: 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)] Receives: 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)] Receives: 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) Receives: Other: diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 18 weeks
Secondary outcomes (4)
factors that may contribute explaining changes in primary outcome measures
body fat composition (MRI and ADP), liver fat (H1-spectroscopy); hormones, adipokines, inflammatory and metabolic markers; insulin signaling pathways in adipose tissue (gene expression and protein level); changes in gut microbiota; bile acids; metabolite profiles; amino acid composition in diet and circulating blood. Relation of secondary outcome measures with primary outcome measures.
Measured: 0, 6, 18 weeks
biomarkers indicating dietary adherence
urinary nitrogen/creatine ratio and fecal BCAA as markers for protein intake; fecal SCFA and breath hydrogen levels as markers for fermentable fiber intake; HDL cholesterol as marker for carbohydrate intake
Measured: 0, 6, 18 weeks
development of indices for the prediction of insulin resistance (liver, whole-body)
Measured: baseline, validation after 6 -18 weeks
development for indices for the prediction of fat mass (liver, abdominal)
Measured: baseline, validation after 6 -18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- German 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
- Responsible party
- Principal investigator, Prof Weickert, Martin O., MD, FRCP, University Hospitals Coventry and Warwickshire NHS Trust
- Investigators
- Martin O Weickert, MD, Study chair, University Hospitals Coventry & Warwickshire; and University of Warwick, UKAndreas FH Pfeiffer, Prof, Study director, German Institute of Human Nutrition Potsdam-Rehbrücke; Charité-University-Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579657
- Sponsor's protocol ID
- mow_PROFIMET
- Other IDs
- BMBF Profimet 0313826A
- Acronym
- PROFIMET
- Status last verified
- Mar 2016
- First submitted
- 21 Dec 2007
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22104550Isken 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.
PubMed 19369060Weickert 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.
PubMed 19366767Weickert 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.
PubMed 18287346Weickert 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.
PubMed 16567814Weickert 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.
PubMed 16172868Weickert 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.
PubMed 21633074Weickert 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.
PubMed 22177085Hattersley 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.
PubMed 22761721Weickert 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.
PubMed 22640465Hattersley 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.
PubMed 25157543Cuthbertson 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.
PubMed 25298375
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Protein and High Cereal Fiber Diets on Insulin Sensitivity in Overweight and Obese Subjects With the Metabolic Syndrome - The PROFIMET Study
- ClinicalTrials.gov ID
- NCT00579657
- Acronym / sponsor ID
- PROFIMET / mow_PROFIMET
- Conditions
- Overweight, Obesity, Metabolic Syndrome
- Keywords
- parameters of metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- German 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
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 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 versus high protein diets over 6 and 18 weeks. We also investigate effects of a combined high-cereal-fiber/high-protein (mix) diet, and effects in a control group. All diets are based on foods from plants and whey products commonly assumed to be healthy. This trial is designed as a proof of principle study focusing on participants that are likely to adhere to the respective isoenergetic diets, in order to show whether high protein versus high cereal fiber diets indeed affect insulin sensitivity, as indicated by epidemiological observations. Study participants will receive intensive and regular nutritional advice in order to achieve the respective dietary targets. Dietary adherence of the participants will be supported by providing tailored dietary supplements in all four groups, twice daily over 18 weeks. Supplements are provided for twice daily consumption for all participants in all four dietary intervention groups, throughout the 18-wk intervention (each of the participants will be instructed to consume a total 252 portions of tailored supplements during the intervention, which will handed to the participants in sealed single portions at weeks 0, 3, 6 and 12, totalling 63 portions at each occasion). The packaging of the sealed portions for the 4 intervention arms do not indicate the type of dietary intervention for the participant, but are coded for identification by the supplier. Energy contents of the supplements are considered when calculating individual energy intake. Supplements have been specifically designed for this intervention study, in order to facilitate achieving dietary targets. A 6 week strictly controlled isoenergetic study period (regular group and individual sessions, daily food diaries/FFQs over the first 6 weeks with adaptation of food intake, if necessary, as indicated by direct analysis of FFQs and food protocols, and by weighing the participants; 3-day food protocols at weeks 0, 6, 12, and 18; various biomarkers of dietary adherence) will be followed by a further 12 week ad libitum period, with ongoing intake of the respective diet including the supplements, but no further dietary advice. The primary outcome measure is the detection of diet-induced changes in insulin sensitivity during weight maintaining isoenergetic conditions. Secondary outcomes are changes in factors that may explain potential diet-induced alterations of insulin sensitivity. During the 12-weeks ad libitum period we will further investigate potential effects of the respective diet on changes in body weight, body composition and biomarkers related to energy intake. Participants will be re-invited for anthropometric measurements and measurement of biomarkers in blood (18 weeks after completion of the study), as well as for taking a second muscle tissue biopsy (subset of participants that agreed to this procedure).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: control diet, supported by dietary supplement twice dailyIntervention: '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)] |
| 2 | Experimental | Other: high cereal fiber diet, supported by dietary supplement twice dailyIntervention: '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)] |
| 3 | Experimental | Other: high protein diet, supported by dietary supplement twice dailyIntervention: '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)] |
| 4 | Experimental | Other: diet moderately high both in cereal fiber and protein, supported by dietary supplement twice dailyIntervention: "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) |
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Diabetes type 1 and type 2
- Pregnancy
- Allergies including food allergies
- Metal implants
- Chronic disease of heart, kidney, or liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control diet, supported by dietary supplement twice dailycontrol diet, see above | Other | 1 |
| high cereal fiber diet, supported by dietary supplement twice dailyhigh cereal fiber diet, see above | Other | 2 |
| high protein diet, supported by dietary supplement twice dailyhigh protein diet, see above | Other | 3 |
| diet moderately high both in cereal fiber and protein, supported by dietary supplement twice dailyMIX diet, see above | Other | 4 |
Primary outcome
change in insulin sensitivity
Time frame: 6 weeks
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
change in insulin sensitivity
Time frame: 18 weeks
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
4 secondary outcomes
factors that may contribute explaining changes in primary outcome measures
Time frame: 0, 6, 18 weeks
biomarkers indicating dietary adherence
Time frame: 0, 6, 18 weeks
development of indices for the prediction of insulin resistance (liver, whole-body)
Time frame: baseline, validation after 6 -18 weeks
development for indices for the prediction of fat mass (liver, abdominal)
Time frame: baseline, validation after 6 -18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Background: PubMed 22104550Gogebakan 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.
- Background: PubMed 19369060Isken 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.
- Background: PubMed 19366767Weickert 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.
- Background: PubMed 18287346Weickert 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.
- Background: PubMed 16567814Weickert 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.
- Background: PubMed 16172868Weickert 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.
- Results publication: PubMed 21633074Weickert 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.
- Results publication: PubMed 22177085Weickert 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.
- Results publication: PubMed 22761721Hattersley 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.
- Results publication: PubMed 22640465Weickert 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.
- Results publication: PubMed 25157543Hattersley 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.
- Results publication: PubMed 25298375Cuthbertson 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.
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Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin O Weickert, MD study chair
University Hospitals Coventry & Warwickshire; and University of Warwick, UK
Andreas FH Pfeiffer, Prof study director
German Institute of Human Nutrition Potsdam-Rehbrücke; Charité-University-Medicine Berlin
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high cereal fiber diet, supported by dietary supplement twice daily, high protein diet, supported by dietary supplement twice daily and diet moderately high both in cereal fiber and protein, supported by dietary supplement twice daily in people with Overweight and Obesity, run by German Institute of Human Nutrition at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in insulin sensitivity (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00579657, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.