Clinical trial NCT05574660: Effect of High-fat/High-sugar Diet on Food Reward Signaling
Official title: Influence of High Fat Feeding on Brain and Behaviour in Individuals at Genetic Risk of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Eating
Lead sponsor: Max Planck Institute for Metabolism Research
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2022-10-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this randomized, single-blinded basic research study, healthy normal-weight human participants are exposed to a high-fat/high-sugar (HF/HS) snack or a low-fat/low-sugar (LF/LS) snack twice a day for eight weeks in addition to their regular diet. All participants are tested at baseline, after 4 weeks and after 8 weeks of dietary intervention.

At all time points the investigators acquire the following parameters:

* Body weight and composition,
* Blood parameters to control for metabolic changes,
* Visual analog scales (hunger, satiety, tiredness, etc.),
* Fat and sugar concentration preference,
* Functional Magnetic Resonance Imaging (fMRI) during a learning and a gustatory perception task.

The investigators hypothesize that the habitual consumption of a small HF/HS snack will reduce the preference for low-fat concentrations and will have an impact on brain response to the anticipation and consumption of palatable food. Moreover, the investigators hypothesize, that HF/HS diet will have an impact neuronal encoding of learning independent of food cues. The investigators expect these alterations independent of body weight gain suggesting a direct effect of HF/HS diet on neuronal circuits.

Detailed description: In this randomized, single-blinded basic research study, healthy normal-weight human participants are exposed to a high-fat/high-sugar (HF/HS) snack or a low-fat/low-sugar (LF/LS) snack twice a day for eight weeks in addition to their regular diet. The investigators test the effect of this dietary intervention on body weight, metabolic parameters such as insulin sensitivity, blood cholesterol and triglycerides, the preference of fat and sugar taste, the brain response to milkshake anticipation and consumption, and as the neuronal coding of prediction error learning. Here, all participants are tested at baseline, after 4 weeks and after 8 weeks of dietary intervention using behavioral tasks, fMRI and blood sampling. The investigators hypothesize that the habitual consumption of a small HF/HS snack will reduce the preference for low-fat concentrations and impact brain response to the anticipation and consumption of palatable food. Moreover, the investigators hypothesize, that HF/HS diet will have an impact neuronal encoding of learning independent of food cues. The investigators expect these alterations independent of body weight gain suggesting a direct effect of HF/HS diet on neuronal circuits.

Eligibility criteria: Inclusion Criteria:

* right handed
* non-smoker (for the last 1 year not smoked more than 2 cigarettes per month)
* Body Mass Index between 20-27 kg/m2 (healthy weight)

Exclusion Criteria:

1. serious or unstable medical illness (e.g., cancer);
2. past or current history of alcoholism or consistent drug use;
3. current and history of major psychiatric illness as defined by the DSM-IV (Diagnostic and Statistical Manual) criteria including eating disorders,
4. medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.) and any psychoactive drugs or anti-obesity agents;
5. history of major head trauma with loss of consciousness;
6. ongoing pregnancy;
7. known taste or smell dysfunction;
8. a diagnosis of diabetes;
9. any known food allergy, certain food sensitivities (lactose);
10. pregnant or nursing women,
11. history of metalworking, injury with shrapnel or metal slivers, and major surgery;
12. history of pacemaker or neurostimulator implantation.

Primary outcomes:
measure: Change in fat taste preference after 8-weeks dietary intervention
timeFrame: Preference (wanting and liking) for different fat and sugar concentrations was assessed at baseline and after the 8-weeks intervention.
measure: Change brain response to milkshake anticipation and milkshake consumption after 8-weeks dietary intervention
timeFrame: BOLD (blood oxygen level-dependent) response to milkshake anticipation and consumption was assessed at baseline and after the 8-weeks intervention.
measure: Change in neuronal encoding of prediction error processing after 8-weeks dietary intervention.
timeFrame: BOLD response related to choice prediction error was assessed at baseline and after 8 weeks of intervention. (http://www.vislab.ucl.ac.uk/Cogent/index.html).For further analysis, the investigators calculated the average rating across the total 12.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Max Planck Institute for Metabolism Research
name: Jens C Bruening, MD
role: STUDY_DIRECTOR
affiliation: Yale University
name: Dana M Small, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Max Planck Institute for Metabolism Research
name: Marc Tittgemeyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: