Processed Meat and Brain Regions Related to Reward and Addiction

NCT02474147 | Completed

• 1 other identifier: G251
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to

1. 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 subjects and healthy controls.
2. 2.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)

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (2)

• Serum concentrations of gastrointestinal hormones

  24 months

• Serum concentrations of oxidative stress markers

  24 months

Study Arms (3)

Type 2 diabetics

EXPERIMENTAL

Patients with type 2 diabetes Interventions: processed meat hamburger and vegan sandwich

Other: Processed meat hamburger; Other: Vegan sandwich

Obese subjects

ACTIVE COMPARATOR

Obese subjects without diabetes Interventions: processed meat hamburger and vegan sandwich

Other: Processed meat hamburger; Other: Vegan sandwich

Healthy lean controls

ACTIVE COMPARATOR

Healthy lean controls Interventions: processed meat hamburger and vegan sandwich

Other: Processed meat hamburger; Other: Vegan sandwich

Interventions

Processed meat hamburger OTHER

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%)

Healthy lean controls; Obese subjects; Type 2 diabetics

Vegan sandwich OTHER

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%)

Healthy lean controls; Obese subjects; Type 2 diabetics

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Czech Republic, 14021, Czechia

Location

Related Publications (2)

• 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.

  PMID: 34507586 DERIVED

• Kahleova 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.

  PMID: 33081982 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dagmar Koveslygetyova, Bc

  Institute for Clinical and Experimental Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 17, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

CZ (1)