Diabetes Mellitus, Type 2LeguANNCT02402985
Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
A study testing High animal protein diet group and High plant protein diet group in people with Diabetes Mellitus, Type 2 and Nutrition Disorders, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Nutrition Disorders, Obesity
- What is being tested?
- High animal protein diet group and High plant protein diet group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Mar 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus, type 2
- HbA1c between 6-11%
Who cannot join
- Consumptive or high grade diseases
- Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
- Diabetes type 1
- Pregnancy
- Chronic disease of heart, kidney, liver
- High grade anaemia
Show all 11Show fewer
- High grade infection disease
- Relevant change of body weight (+/- 5 kg) since 8 weeks before begin of study Intervention
- Missing data about primary outcome measures (hyperinsulinaemic euglycaemic clamp, mealtime test, data about dietary intake from food diaries or food protocols)
- Significant deviation from dietary targets during the monitored 6 weeks isoenergetic period
- Allergies including food allergies
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Institute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, 14558
About this study
Official title: Comparison of a High-protein, Carbohydrate-restricted Diet With a High Proportion of Leguminous Protein Compared to Animal Protein on Metabolic Control in Patients With Type 2 Diabetes, "LeguAN Study"
This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism.
Read the detailed description
2x20 patients with Diabetes mellitus type 2 are randomise by a blind computer assist for an equal allocation in both groups (animal protein vs. plant protein). The food components for both groups are 40% carbohydrates, 30% fat and 30% protein. The carbohydrates are correspond with a high fiber content and a low blood sugar effectiveness of carbohydrates (glycemic index).
- Conditions
- Diabetes Mellitus, Type 2, Nutrition Disorders, Obesity, Body Weight, Metabolic Syndrome x, Metabolic Diseases
- Being tested
- High animal protein diet group, High plant protein diet group
- Keywords
- nutritional support, diet therapy, protein diet, isocaloric diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Nutrition Disorders, Obesity, Body Weight, Metabolic Syndrome, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High animal protein diet groupOther
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
High plant protein diet groupOther
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| High animal protein diet group AP | Other | 6-weeks diet intervention with high animal protein Receives: Other: High animal protein diet group |
| High plant protein diet group PP | Other | 6-weeks diet intervention with high plant protein Receives: Other: High plant protein diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variance of glucose metabolism after different diet intervention
Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT)
Measured: week 0 and 6
Secondary outcomes (8)
Development of indices for the prediction of liver fat mass
Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy
Measured: week 0 and 6
Development of indices for the prediction of body fat mass
Change of body fat measuring by body composition assessment (BODPOD) and bioelectrical impedance analysis (BIA)
Measured: week 0, 2, 4 and 6
Expression Change of inflammatory markers in blood and fat tissue
Measurement of gene expression of inflammation cytokines
Measured: week 0 and 6
Modification of epigenetic DNA
Measured: week 0 and 6
Changes of gastrointestinal microbiota
Molecular mechanisms between nutrition, intestinal bacteria and host
Measured: week 0 and 6
Variance of composite biometric data
Change of blood pressure, weight, body mass index, waist-hip ratio
Measured: week 0, 2, 4 and 6
Variance of blood data
Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers
Measured: week 0, 2, 4 and 6
Variance of intestinal hormones
Change of intestinal hormones measured with a meal time test (MTT)
Measured: week o and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Agriculture, Germany, Ernst von Bergmann Hospital, University Hospital Tuebingen, Institute of Gain Processing IGV GmbH, Potsdam
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
- Investigators
- Andreas FH Pfeiffer, Prof, Principal investigator, German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402985
- Sponsor's protocol ID
- BMLEV-Project
- Acronym
- LeguAN
- Status last verified
- Apr 2015
- First submitted
- 4 Feb 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kabisch S, Markova M, Hornemann S, Sucher S, Pivovarova-Ramich O, Machann J, Hierholzer J, Rohn S, Pfeiffer AFH. Liver fat scores do not reflect interventional changes in liver fat content induced by high-protein diets. Sci Rep. 2021 Apr 23;11(1):8843. doi: 10.1038/s41598-021-87360-2.
PubMed 33893355Markova M, Koelman L, Hornemann S, Pivovarova O, Sucher S, Machann J, Rudovich N, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AFH, Aleksandrova K. Effects of plant and animal high protein diets on immune-inflammatory biomarkers: A 6-week intervention trial. Clin Nutr. 2020 Mar;39(3):862-869. doi: 10.1016/j.clnu.2019.03.019. Epub 2019 Mar 27.
PubMed 30967307Markova M, Hornemann S, Sucher S, Wegner K, Pivovarova O, Rudovich N, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AFH. Rate of appearance of amino acids after a meal regulates insulin and glucagon secretion in patients with type 2 diabetes: a randomized clinical trial. Am J Clin Nutr. 2018 Aug 1;108(2):279-291. doi: 10.1093/ajcn/nqy100.
PubMed 29982277Markova M, Pivovarova O, Hornemann S, Sucher S, Frahnow T, Wegner K, Machann J, Petzke KJ, Hierholzer J, Lichtinghagen R, Herder C, Carstensen-Kirberg M, Roden M, Rudovich N, Klaus S, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AF. Isocaloric Diets High in Animal or Plant Protein Reduce Liver Fat and Inflammation in Individuals With Type 2 Diabetes. Gastroenterology. 2017 Feb;152(3):571-585.e8. doi: 10.1053/j.gastro.2016.10.007. Epub 2016 Oct 17.
PubMed 27765690
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a High-protein, Carbohydrate-restricted Diet With a High Proportion of Leguminous Protein Compared to Animal Protein on Metabolic Control in Patients With Type 2 Diabetes, "LeguAN Study"
- ClinicalTrials.gov ID
- NCT02402985
- Acronym / sponsor ID
- LeguAN / BMLEV-Project
- Conditions
- Diabetes Mellitus, Type 2, Nutrition Disorders, Obesity, Body Weight, Metabolic Syndrome x, Metabolic Diseases
- Keywords
- nutritional support, diet therapy, protein diet, isocaloric diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Ministry of Food and Agriculture, Germany, Ernst von Bergmann Hospital, University Hospital Tuebingen, Institute of Gain Processing IGV GmbH, Potsdam
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Mar 2015 (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.
This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism.
Detailed description
2x20 patients with Diabetes mellitus type 2 are randomise by a blind computer assist for an equal allocation in both groups (animal protein vs. plant protein). The food components for both groups are 40% carbohydrates, 30% fat and 30% protein. The carbohydrates are correspond with a high fiber content and a low blood sugar effectiveness of carbohydrates (glycemic index).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High animal protein diet group AP | Other | Other: High animal protein diet group6-weeks diet intervention with high animal protein |
| High plant protein diet group PP | Other | Other: High plant protein diet group6-weeks diet intervention with high plant protein |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes mellitus, type 2
- HbA1c between 6-11%
Key exclusion criteria (11 listed)
- Consumptive or high grade diseases
- Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
- Diabetes type 1
- Pregnancy
- Chronic disease of heart, kidney, 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 |
|---|---|---|
| High animal protein diet group25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks | Other | High animal protein diet group AP |
| High plant protein diet group25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks | Other | High plant protein diet group PP |
Primary outcome
Variance of glucose metabolism after different diet intervention
Time frame: week 0 and 6
Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT)
8 secondary outcomes
Development of indices for the prediction of liver fat mass
Time frame: week 0 and 6
Development of indices for the prediction of body fat mass
Time frame: week 0, 2, 4 and 6
Expression Change of inflammatory markers in blood and fat tissue
Time frame: week 0 and 6
Modification of epigenetic DNA
Time frame: week 0 and 6
Changes of gastrointestinal microbiota
Time frame: week 0 and 6
Variance of composite biometric data
Time frame: week 0, 2, 4 and 6
Variance of blood data
Time frame: week 0, 2, 4 and 6
Variance of intestinal hormones
Time frame: week o and 6
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 30 Apr 2015.
- Derived from this study: PubMed 33893355Kabisch S, Markova M, Hornemann S, Sucher S, Pivovarova-Ramich O, Machann J, Hierholzer J, Rohn S, Pfeiffer AFH. Liver fat scores do not reflect interventional changes in liver fat content induced by high-protein diets. Sci Rep. 2021 Apr 23;11(1):8843. doi: 10.1038/s41598-021-87360-2.
- Derived from this study: PubMed 30967307Markova M, Koelman L, Hornemann S, Pivovarova O, Sucher S, Machann J, Rudovich N, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AFH, Aleksandrova K. Effects of plant and animal high protein diets on immune-inflammatory biomarkers: A 6-week intervention trial. Clin Nutr. 2020 Mar;39(3):862-869. doi: 10.1016/j.clnu.2019.03.019. Epub 2019 Mar 27.
- Derived from this study: PubMed 29982277Markova M, Hornemann S, Sucher S, Wegner K, Pivovarova O, Rudovich N, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AFH. Rate of appearance of amino acids after a meal regulates insulin and glucagon secretion in patients with type 2 diabetes: a randomized clinical trial. Am J Clin Nutr. 2018 Aug 1;108(2):279-291. doi: 10.1093/ajcn/nqy100.
- Derived from this study: PubMed 27765690Markova M, Pivovarova O, Hornemann S, Sucher S, Frahnow T, Wegner K, Machann J, Petzke KJ, Hierholzer J, Lichtinghagen R, Herder C, Carstensen-Kirberg M, Roden M, Rudovich N, Klaus S, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AF. Isocaloric Diets High in Animal or Plant Protein Reduce Liver Fat and Inflammation in Individuals With Type 2 Diabetes. Gastroenterology. 2017 Feb;152(3):571-585.e8. doi: 10.1053/j.gastro.2016.10.007. Epub 2016 Oct 17.
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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.
Andreas FH Pfeiffer, Prof principal investigator
German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High animal protein diet group and High plant protein diet group in people with Diabetes Mellitus, Type 2 and Nutrition Disorders, run by German Institute of Human Nutrition at 1 site in Germany.
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 2 inclusion and 11 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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?
Variance of glucose metabolism after different diet intervention (time frame: week 0 and 6). 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 NCT02402985, which also lists 4 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 30 Apr 2015.