NCT Number: NCT05353504
The investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. To this end, 90 overweight/obese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. Before and after the intervention/control period, participants will undergo task-based functional and structural MRI and cognitive testing. The gut microbiota will be assessed using 16S rDNA next-generation sequencing (V3/V4 region) in stool samples. Diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. SCFA). Using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. Related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Leipzig, Germany
Location status: Recruiting
Meghedi Vartanian, Msc
CONTACT
+49(0)341/9940-954
Silke Friedrich
CONTACT
+49(0)341/9940-954
Veronica Witte, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
28g/day delivered in 2 sachets throughout the day with main meals
weekly educational sessions to improve individual's eating behaviour
equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals
Time frame: 6 months
BOLD-acitvity will be measured using event-related echo-planar T2*-weighted magnetic resonance imaging (MRI) during food wanting task according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Wanting rating scores (on an 8-point likert scale) per stimulus will be added as covariates. In a parallel model, kcal of food stimuli will be added multiplied with wanting scores to model high caloric food wanting interaction. At the group level, we will assess the contrasts food > art and wanting modulation.
Time frame: 6 months
Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples
Time frame: 6 months
BOLD-acitvity will be measured using event-related echo-planar T2*-weighted magnetic resonance imaging (MRI) during food wanting and food memory recognition tasks according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation in encoding and recognition will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Correctly remembered and correctly rejected, as well as misses and false alarms will be modeled separately. In parallel models, similar and new items als well as wanting rating scores (on an 8-point likert scale) per stimulus and kcal of food stimuli multiplied with wanting scores will be added as covariates. At the group level, we will assess the contrasts correct > false and wanting modulation.
Time frame: 6 months
self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).
Time frame: 6 months
ghrelin pg/ml in blood
Time frame: 6 months
leptin ng/ml in blood
Time frame: 6 months
Glucagon-like peptide-1 (GLP-1) pg/ml in blood
Time frame: 6 months
peptide YY pg/ml in blood
Time frame: 6 months
insulin in blood uU/ml
Time frame: 6 months
hemoglycated globulin A1c in blood %
Time frame: 6 months
high sensitive C-reactive protein mg/l (and optionally tumor necrosis factor alpha and interleukin 6 in blood, pg/ml)
Time frame: 6 months
short-chain fatty acids (SCFA), bile acids
Time frame: 6 months
weight kg/height in m squared
Time frame: 6 months
waist (cm) to hip (cm) circumeference ratio
Time frame: 6 months
body fat % according to bioelectrical impedance analysis
Time frame: 6 months
assessed with the food craving questionnaire (Meule et al., 2012, German version).
Time frame: 6 months
measured using the attention network task (ANT)
Contact information is provided by the study sponsor or research team.
Max Planck Institute for Human Cognitive and Brain Sciences
Other
"SFB 1052/3 - Mechanismen Der Adipositas, Projekt A1: Veränderung Der Neurobiologischen Grundlagen Von Ess-Entscheidungen Bei Adipositas" Engl. "CRC 1052/3 - Obesity Mechanisms, Project A1: Targeting Neurobehavioral Determinants of Obesity"
Acronym: MIFOOD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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