Type 2 DiabetesRewCravNCT02474147
Processed Meat and Brain Regions Related to Reward and Addiction
A study testing Processed meat hamburger and Vegan sandwich in people with Type 2 Diabetes, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
The purpose of this study is to 1. Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Processed meat hamburger and Vegan sandwich
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- Aug 2015to Dec 2017
- 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 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus for at least one year
- Treatment of T2D: diet or oral antidiabetic agents (stable drug therapy at least 3 month before the trial
- The presence of metabolic syndrome - any three of the following symptoms:
- Abdominal obesity - waist circumf. in men> 102 cm, in women > 88 cm
- Diagnosis and treatment of type 2 diabetes or raised fasting plasma glucose level (FPG>5,6 mmol/l)
- Raised blood pressure (BP): systolic BP > 130 mm Hg or diastolic BP >85 mm Hg, or treatment of previously diagnosed hypertension
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- Reduced HDL cholesterol in men < 1 mmol/l, in women < 1,3 mmol/l (or treatment)
- Raised triglycerides > 1,7 mmol/l (or treatment)
- HbA1c (according to IFCC) ≥4.2 a ≤10.5%
- Men and women aged 30-70 years
- Body Mass Index (kg/m2) in the range of 25- 45
- The signed informed consent
Who cannot join
- Type 1 diabetes mellitus
- Unstable drug therapy at least 3 month before the trial
- Treatment with Byetta or Victosa
- Pregnancy (positive β-HCG test), breast feeding or trying to become pregnant
- Presence of pacemaker or other metal implant in the body (MR)
- Alcoholism or drug use
Show all 9Show fewer
- Significant weight loss (more than 5% of body weight) in previous 3 months before the screening
- Presence of other medical condition, which occurs during physical examination, laboratory tests, ECG, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
- Metal in the body (fMRI)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute for Clinical and Experimental Medicine
Prague, Czech Republic, 14021
About this study
Official title: Effects of Processed Meat on Brain Regions Related to Reward and Craving in Patients With Type 2 Diabetes, Obese Subjects and Healthy Controls
The purpose of this study is to
- Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese subjects and healthy controls.
- Characterize some of the pathophysiological mechanisms of action of different meals in obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)
Read the detailed description
The mesolimbic dopaminergic system of the brain, which converges on the nucleus accumbens (part of the striatum), plays a central role in reward and craving, and this system appears to mediate hedonic food responses. In rodent studies, extracellular concentrations of dopamine and its metabolites in the nucleus accumbens increased more after the consumption of highly palatable food than standard rodent feed pellets. Furthermore, microinjections of opiate into the nucleus accumbens increased food intake and the reward value of food. Clinical studies that used functional brain imaging have reported greater activation in the nucleus accumbens or other regions of the striatum in obese than lean individuals after they viewed or consumed palatable, high-calorie food. Of particular interest, striatal dopamine D2 receptor availability was significantly lower in obese individuals than in nonobese matched controls, which raised the possibility that overeating may compensate for low dopaminergic activity. The recurrent activation of the striatum may down-regulate dopamine availability and further heighten the drive to overeat. However, the information on the exact effect of different foods and nutrients on the mesolimbic dopaminergic system is missing.
Preliminary findings that lead to the project
A positive association between high consumption of total and red meat, especially processed meat, and incidence of T2D has been demonstrated. Previous studies support the concept that increased oxidative stress may play an important role in T2D manifestation. Dietary fat quality has been proposed to be a critical factor. Several studies have suggested that a high intake of saturated fatty acids naturally present in meat contributes to the risk of glucose intolerance. In an intervention study, humans suffering from metabolic syndrome who were consuming a diet rich in saturated fats displayed higher oxidative stress markers postprandially. It is not clear if saturated fatty acids per se or via increased oxidative stress markers may activate the mesolimbic dopaminergic system.
In contrast, some intervention trials (including ours) demonstrated a greater improvement in insulin sensitivity, glycemic control and a reduction in oxidative stress markers in T2D patients consuming a vegetarian diet compared to a conventional diabetic diet. The effect of a vegetarian diet on the mesolimbic dopaminergic system has not been studied yet.
Aims and priorities of the project
The purpose of this study is to
- Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese subjects and healthy controls.
- Characterize some of the pathophysiological mechanisms of action of different meals in obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)
Hypothesis
- Obese and T2D subjects relative to lean healthy controls will show greater activation in the gustatory cortex and in somatosensory regions in response to the intake of processed meat hamburger (vs. a vegetarian sandwich). However, they will also show decreased activation in the caudate nucleus in response to consumption of processed meat hamburger (vs. a vegetarian sandwich).
- Changes in serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones and oxidative stress markers will be involved in gut-brain axis signaling. The investigators hypothesise to find an association between postprandial changes in serum concentrations of FFA and postprandial changes in activation in the gustatory cortex and in somatosensory regions of the brain.
The actual need for this study The pandemic of obesity and diabetes especially in western countries calls for high-quality research and relevant action. A better understanding of the pathophysiological mechanisms of the stimulation of brain regions involved in reward and craving in response to processed meat, one of the most significant present risk factors for obesity and type 2 diabetes, is needed in order to develop more effective preventive and therapeutic strategies.
- Conditions
- Type 2 Diabetes
- Being tested
- Processed meat hamburger, Vegan sandwich
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed meat hamburgerOther
MacMuffin Fresh 300 ml Cafe Latte + 21 g sugar Energy: 513.6 kcal Carbohydrates 55g (44.8%) Proteins 20.5g (16.7%) Lipids 22 g (38.6%)
Vegan sandwichOther
Burger with tofu + 300 ml green tea Energy 514.9 kcal Carbohydrates 54.2 g (44%) Proteins 19.9 g (16.2%) Lipids 22.8 g (39.8%)
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetics | Experimental | Patients with type 2 diabetes Interventions: processed meat hamburger and vegan sandwich Receives: Other: Processed meat hamburger; Other: Vegan sandwich |
| Obese subjects | Active comparator | Obese subjects without diabetes Interventions: processed meat hamburger and vegan sandwich Receives: Other: Processed meat hamburger; Other: Vegan sandwich |
| Healthy lean controls | Active comparator | Healthy lean controls Interventions: processed meat hamburger and vegan sandwich Receives: Other: Processed meat hamburger; Other: Vegan sandwich |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain imaging of reward circuitry
fMRI (functional magnetic resonance imaging) of the brain pre- and postprandially simultaneously with both meal tests with the use of the modern method of arterial spin labeling (ASL) which allows quantification of the blood perfusion of the brain regions involved in craving and reward.
Measured: 24 months
Secondary outcomes (2)
Serum concentrations of gastrointestinal hormones
Plasma concentrations of selected gut hormones will be measured enzymatically using standard kits
Measured: 24 months
Serum concentrations of oxidative stress markers
Plasma concentrations of selected oxidative stress markers will be measured enzymatically using standard kits
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hana Kahleova, Institute for Clinical and Experimental Medicine
- Investigators
- Dagmar Koveslygetyova, Bc, Study chair, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474147
- Sponsor's protocol ID
- G251
- Acronym
- RewCrav
- Status last verified
- Mar 2018
- First submitted
- 2 Jun 2015
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Malinska H, Klementova M, Kudlackova M, Veleba J, Hoskova E, Oliyarnyk O, Markova I, Thieme L, Hill M, Pelikanova T, Kahleova H. A plant-based meal reduces postprandial oxidative and dicarbonyl stress in men with diabetes or obesity compared with an energy- and macronutrient-matched conventional meal in a randomized crossover study. Nutr Metab (Lond). 2021 Sep 10;18(1):84. doi: 10.1186/s12986-021-00609-5.
PubMed 34507586Kahleova H, Tintera J, Thieme L, Veleba J, Klementova M, Kudlackova M, Malinska H, Oliyarnyk O, Markova I, Haluzik M, Pavlovicova R, Hill M, Tura A, Pelikanova T. A plant-based meal affects thalamus perfusion differently than an energy- and macronutrient-matched conventional meal in men with type 2 diabetes, overweight/obese, and healthy men: A three-group randomized crossover study. Clin Nutr. 2021 Apr;40(4):1822-1833. doi: 10.1016/j.clnu.2020.10.005. Epub 2020 Oct 9.
PubMed 33081982
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Processed Meat on Brain Regions Related to Reward and Craving in Patients With Type 2 Diabetes, Obese Subjects and Healthy Controls
- ClinicalTrials.gov ID
- NCT02474147
- Acronym / sponsor ID
- RewCrav / G251
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Jun 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.
The purpose of this study is to
- Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese subjects and healthy controls.
- Characterize some of the pathophysiological mechanisms of action of different meals in obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)
Detailed description
The mesolimbic dopaminergic system of the brain, which converges on the nucleus accumbens (part of the striatum), plays a central role in reward and craving, and this system appears to mediate hedonic food responses. In rodent studies, extracellular concentrations of dopamine and its metabolites in the nucleus accumbens increased more after the consumption of highly palatable food than standard rodent feed pellets. Furthermore, microinjections of opiate into the nucleus accumbens increased food intake and the reward value of food. Clinical studies that used functional brain imaging have reported greater activation in the nucleus accumbens or other regions of the striatum in obese than lean individuals after they viewed or consumed palatable, high-calorie food. Of particular interest, striatal dopamine D2 receptor availability was significantly lower in obese individuals than in nonobese matched controls, which raised the possibility that overeating may compensate for low dopaminergic activity. The recurrent activation of the striatum may down-regulate dopamine availability and further heighten the drive to overeat. However, the information on the exact effect of different foods and nutrients on the mesolimbic dopaminergic system is missing.
Preliminary findings that lead to the project
A positive association between high consumption of total and red meat, especially processed meat, and incidence of T2D has been demonstrated. Previous studies support the concept that increased oxidative stress may play an important role in T2D manifestation. Dietary fat quality has been proposed to be a critical factor. Several studies have suggested that a high intake of saturated fatty acids naturally present in meat contributes to the risk of glucose intolerance. In an intervention study, humans suffering from metabolic syndrome who were consuming a diet rich in saturated fats displayed higher oxidative stress markers postprandially. It is not clear if saturated fatty acids per se or via increased oxidative stress markers may activate the mesolimbic dopaminergic system.
In contrast, some intervention trials (including ours) demonstrated a greater improvement in insulin sensitivity, glycemic control and a reduction in oxidative stress markers in T2D patients consuming a vegetarian diet compared to a conventional diabetic diet. The effect of a vegetarian diet on the mesolimbic dopaminergic system has not been studied yet.
Aims and priorities of the project
The purpose of this study is to
- Compare effects of two isocaloric meals (processed meat hamburger vs. vegetarian sandwich) in response to the postprandial period by using functional brain imaging of reward circuitry implicated in food motivation and energy balance in patients with type 2 diabetes (T2D), obese subjects and healthy controls.
- Characterize some of the pathophysiological mechanisms of action of different meals in obese and T2D subjects vs. in healthy controls (serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones, oxidative stress markers)
Hypothesis
- Obese and T2D subjects relative to lean healthy controls will show greater activation in the gustatory cortex and in somatosensory regions in response to the intake of processed meat hamburger (vs. a vegetarian sandwich). However, they will also show decreased activation in the caudate nucleus in response to consumption of processed meat hamburger (vs. a vegetarian sandwich).
- Changes in serum concentrations of glucose, FFA, IRI, C-peptide, gastrointestinal hormones and oxidative stress markers will be involved in gut-brain axis signaling. The investigators hypothesise to find an association between postprandial changes in serum concentrations of FFA and postprandial changes in activation in the gustatory cortex and in somatosensory regions of the brain.
The actual need for this study The pandemic of obesity and diabetes especially in western countries calls for high-quality research and relevant action. A better understanding of the pathophysiological mechanisms of the stimulation of brain regions involved in reward and craving in response to processed meat, one of the most significant present risk factors for obesity and type 2 diabetes, is needed in order to develop more effective preventive and therapeutic strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetics | Experimental | Other: Processed meat hamburger, Other: Vegan sandwichPatients with type 2 diabetes Interventions: processed meat hamburger and vegan sandwich |
| Obese subjects | Active comparator | Other: Processed meat hamburger, Other: Vegan sandwichObese subjects without diabetes Interventions: processed meat hamburger and vegan sandwich |
| Healthy lean controls | Active comparator | Other: Processed meat hamburger, Other: Vegan sandwichHealthy lean controls Interventions: processed meat hamburger and vegan sandwich |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Type 2 diabetes mellitus for at least one year
- Treatment of T2D: diet or oral antidiabetic agents (stable drug therapy at least 3 month before the trial
- The presence of metabolic syndrome - any three of the following symptoms:
- HbA1c (according to IFCC) ≥4.2 a ≤10.5%
- Men and women aged 30-70 years
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus
- Unstable drug therapy at least 3 month before the trial
- Treatment with Byetta or Victosa
- Pregnancy (positive β-HCG test), breast feeding or trying to become pregnant
- Presence of pacemaker or other metal implant in the body (MR)
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 |
|---|---|---|
| Processed meat hamburgerMacMuffin Fresh 300 ml Cafe Latte + 21 g sugar Energy: 513.6 kcal Carbohydrates 55g (44.8%) Proteins 20.5g (16.7%) Lipids 22 g (38.6%) | Other | Healthy lean controls, Obese subjects, Type 2 diabetics |
| Vegan sandwichBurger with tofu + 300 ml green tea Energy 514.9 kcal Carbohydrates 54.2 g (44%) Proteins 19.9 g (16.2%) Lipids 22.8 g (39.8%) | Other | Healthy lean controls, Obese subjects, Type 2 diabetics |
Primary outcome
Functional brain imaging of reward circuitry
Time frame: 24 months
fMRI (functional magnetic resonance imaging) of the brain pre- and postprandially simultaneously with both meal tests with the use of the modern method of arterial spin labeling (ASL) which allows quantification of the blood perfusion of the brain regions involved in craving and reward.
2 secondary outcomes
Serum concentrations of gastrointestinal hormones
Time frame: 24 months
Serum concentrations of oxidative stress markers
Time frame: 24 months
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 27 Mar 2018.
- Derived from this study: PubMed 34507586Malinska H, Klementova M, Kudlackova M, Veleba J, Hoskova E, Oliyarnyk O, Markova I, Thieme L, Hill M, Pelikanova T, Kahleova H. A plant-based meal reduces postprandial oxidative and dicarbonyl stress in men with diabetes or obesity compared with an energy- and macronutrient-matched conventional meal in a randomized crossover study. Nutr Metab (Lond). 2021 Sep 10;18(1):84. doi: 10.1186/s12986-021-00609-5.
- Derived from this study: PubMed 33081982Kahleova H, Tintera J, Thieme L, Veleba J, Klementova M, Kudlackova M, Malinska H, Oliyarnyk O, Markova I, Haluzik M, Pavlovicova R, Hill M, Tura A, Pelikanova T. A plant-based meal affects thalamus perfusion differently than an energy- and macronutrient-matched conventional meal in men with type 2 diabetes, overweight/obese, and healthy men: A three-group randomized crossover study. Clin Nutr. 2021 Apr;40(4):1822-1833. doi: 10.1016/j.clnu.2020.10.005. Epub 2020 Oct 9.
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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.
Dagmar Koveslygetyova, Bc study chair
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed meat hamburger and Vegan sandwich in people with Type 2 Diabetes, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 12 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 27 Mar 2018. 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 Czechia. 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?
Functional brain imaging of reward circuitry (time frame: 24 months). 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 NCT02474147, which also lists 2 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 27 Mar 2018.