Behavior, EatingNCT05574660
Effect of High-fat/High-sugar Diet on Food Reward Signaling
A study testing High-Fat/High-Sugar (HF/HS) Diet and Low-Fat/Low-Sugar (LF/LS) Diet in people with Behavior, Eating, run by Max Planck Institute for Metabolism Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Eating
- What is being tested?
- High-Fat/High-Sugar (HF/HS) Diet and Low-Fat/Low-Sugar (LF/LS) Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2016to 24 Oct 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- serious or unstable medical illness (e.g., cancer);
- past or current history of alcoholism or consistent drug use;
- current and history of major psychiatric illness as defined by the DSM-IV (Diagnostic and Statistical Manual) criteria including eating disorders,
- medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.) and any psychoactive drugs or anti-obesity agents;
- history of major head trauma with loss of consciousness;
- ongoing pregnancy;
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- known taste or smell dysfunction;
- a diagnosis of diabetes;
- any known food allergy, certain food sensitivities (lactose);
- pregnant or nursing women,
- history of metalworking, injury with shrapnel or metal slivers, and major surgery;
- history of pacemaker or neurostimulator implantation.
About this study
Official title: Influence of High Fat Feeding on Brain and Behaviour in Individuals at Genetic Risk of Obesity
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:
Read more
- 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.
Read the 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.
- Conditions
- Behavior, Eating
- Being tested
- High-Fat/High-Sugar (HF/HS) Diet, Low-Fat/Low-Sugar (LF/LS) Diet
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fat/High-Sugar (HF/HS) DietDietary supplement
Low-Fat/Low-Sugar (LF/LS) DietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| High-Fat/High-Sugar (HF/HS) Diet | Experimental | Participants randomized to consume an HF/HS yoghurt (40.8 % kcal from fat, 45.6 % kcal from carbohydrates, 13 % kcal from protein of 79.5 total kcal) two times a day for eight weeks in addition to their normal diet. Receives: Dietary Supplement: High-Fat/High-Sugar (HF/HS) Diet |
| Low-Fat/Low-Sugar (LF/LS) Diet | Experimental | Participants randomized to consume an LF/LS yoghurt (17.1 % kcal from fat, 29.1 % kcal from carbohydrates, 51.9 % kcal from protein of 78 total kcal) two times a day for eight weeks in addition to their normal diet. Receives: Dietary Supplement: Low-Fat/Low-Sugar (LF/LS) Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat taste preference after 8-weeks dietary intervention
In the fat and sugar concentration preference task, the preference and perception are evaluated using a series of puddings with varying fat content (0%, 3.1%, 6.9%, and 15.6 %), and sugar concentration using apple juice with varying sucrose content (0 M, 0.1 M, 0.56 M, and 1 M). Each pudding and juice concentration is tested 12 times and the average is calculated. "Wanting" and "Liking" are assessed for all concentrations and the change between baseline and the post-intervention is assessed in both HF/HS and LF/LS groups.
Measured: Preference (wanting and liking) for different fat and sugar concentrations was assessed at baseline and after the 8-weeks intervention.
Change brain response to milkshake anticipation and milkshake consumption after 8-weeks dietary intervention
To test the effect of the dietary intervention on brain responses to milkshake anticipation (milkshake predicting cue) and consumption (milkshake delivery), the investigators performed a gustatory perception task. The BOLD response while milkshake cue presentation and milkshake delivery was compared between baseline and postintervention and compared between groups.
Measured: BOLD (blood oxygen level-dependent) response to milkshake anticipation and consumption was assessed at baseline and after the 8-weeks intervention.
Change in neuronal encoding of prediction error processing after 8-weeks dietary intervention.
A short version of the sensory learning task as described in detail by Iglesias et al. (2019) was performed to assess associative learning independent of food rewards, while undergoing fMRI. Within this model, the investigators computed the (signed) adaptive precision error relating to the precision-weighted choice prediction error about visual outcome, that is, the product of choice prediction error (a) and the adaptive learning rate (b). The investigators tested the BOLD response related to choice prediction error and compared it between baseline and post-intervention and between the HF/HS and LF/LS group.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start9 Mar 2016
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, EatingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Planck Institute for Metabolism Research
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Marc Tittgemeyer, Max Planck Institute for Metabolism Research
- Investigators
- Jens C Bruening, MD, Study director, Max Planck Institute for Metabolism ResearchDana M Small, PhD, Principal investigator, Yale UniversityMarc Tittgemeyer, PhD, Principal investigator, Max Planck Institute for Metabolism Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574660
- Sponsor's protocol ID
- HF-01
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of High Fat Feeding on Brain and Behaviour in Individuals at Genetic Risk of Obesity
- ClinicalTrials.gov ID
- NCT05574660
- Acronym / sponsor ID
- HF-01
- Conditions
- Behavior, Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Max Planck Institute for Metabolism ResearchUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 10 Oct 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Fat/High-Sugar (HF/HS) Diet | Experimental | Dietary Supplement: High-Fat/High-Sugar (HF/HS) DietParticipants randomized to consume an HF/HS yoghurt (40.8 % kcal from fat, 45.6 % kcal from carbohydrates, 13 % kcal from protein of 79.5 total kcal) two times a day for eight weeks in addition to their normal diet. |
| Low-Fat/Low-Sugar (LF/LS) Diet | Experimental | Dietary Supplement: Low-Fat/Low-Sugar (LF/LS) DietParticipants randomized to consume an LF/LS yoghurt (17.1 % kcal from fat, 29.1 % kcal from carbohydrates, 51.9 % kcal from protein of 78 total kcal) two times a day for eight weeks in addition to their normal diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- serious or unstable medical illness (e.g., cancer);
- past or current history of alcoholism or consistent drug use;
- current and history of major psychiatric illness as defined by the DSM-IV (Diagnostic and Statistical Manual) criteria including eating disorders,
- medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.) and any psychoactive drugs or anti-obesity agents;
- history of major head trauma with loss of consciousness;
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-Fat/High-Sugar (HF/HS) Diet | Dietary supplement | High-Fat/High-Sugar (HF/HS) Diet |
| Low-Fat/Low-Sugar (LF/LS) Diet | Dietary supplement | Low-Fat/Low-Sugar (LF/LS) Diet |
Primary outcome
Change in fat taste preference after 8-weeks dietary intervention
Time frame: Preference (wanting and liking) for different fat and sugar concentrations was assessed at baseline and after the 8-weeks intervention.
In the fat and sugar concentration preference task, the preference and perception are evaluated using a series of puddings with varying fat content (0%, 3.1%, 6.9%, and 15.6 %), and sugar concentration using apple juice with varying sucrose content (0 M, 0.1 M, 0.56 M, and 1 M). Each pudding and juice concentration is tested 12 times and the average is calculated. "Wanting" and "Liking" are assessed for all concentrations and the change between baseline and the post-intervention is assessed in both HF/HS and LF/LS groups.
Change brain response to milkshake anticipation and milkshake consumption after 8-weeks dietary intervention
Time frame: BOLD (blood oxygen level-dependent) response to milkshake anticipation and consumption was assessed at baseline and after the 8-weeks intervention.
To test the effect of the dietary intervention on brain responses to milkshake anticipation (milkshake predicting cue) and consumption (milkshake delivery), the investigators performed a gustatory perception task. The BOLD response while milkshake cue presentation and milkshake delivery was compared between baseline and postintervention and compared between groups.
Change in neuronal encoding of prediction error processing after 8-weeks dietary intervention.
Time frame: 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.
A short version of the sensory learning task as described in detail by Iglesias et al. (2019) was performed to assess associative learning independent of food rewards, while undergoing fMRI. Within this model, the investigators computed the (signed) adaptive precision error relating to the precision-weighted choice prediction error about visual outcome, that is, the product of choice prediction error (a) and the adaptive learning rate (b). The investigators tested the BOLD response related to choice prediction error and compared it between baseline and post-intervention and between the HF/HS and LF/LS group.
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 10 Oct 2022.
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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.
Jens C Bruening, MD study director
Max Planck Institute for Metabolism Research
Dana M Small, PhD principal investigator
Yale University
Marc Tittgemeyer, PhD principal investigator
Max Planck Institute for Metabolism Research
Questions about this trial
What is this clinical trial studying?
A study testing High-Fat/High-Sugar (HF/HS) Diet and Low-Fat/Low-Sugar (LF/LS) Diet in people with Behavior, Eating, run by Max Planck Institute for Metabolism Research.
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 3 inclusion and 12 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in fat taste preference after 8-weeks dietary intervention (time frame: Preference (wanting and liking) for different fat and sugar concentrations was assessed at baseline and after the 8-weeks intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.