Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effect of High-fat/High-sugar Diet on Food Reward Signaling

7 ottobre 2022 aggiornato da: Marc Tittgemeyer, Max Planck Institute for Metabolism Research

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:

  • 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

82

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: High-Fat/High-Sugar (HF/HS) Diet
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.
Integratore alimentare: High-Fat/High-Sugar (HF/HS) Diet
Sperimentale: Low-Fat/Low-Sugar (LF/LS) Diet
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.
Integratore alimentare: Low-Fat/Low-Sugar (LF/LS) Diet

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in fat taste preference after 8-weeks dietary intervention
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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.
Lasso di tempo: 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.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Max Planck Institute for Metabolism Research

Collaboratori

Yale University

Investigatori

  • Direttore dello studio: Jens C Bruening, MD, Max Planck Institute for Metabolism Research
  • Investigatore principale: Dana M Small, PhD, Yale University
  • Investigatore principale: Marc Tittgemeyer, PhD, Max Planck Institute for Metabolism Research

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 marzo 2016

Completamento primario (Effettivo)

24 ottobre 2018

Completamento dello studio (Effettivo)

24 ottobre 2018

Date di iscrizione allo studio

Primo inviato

5 ottobre 2022

Primo inviato che soddisfa i criteri di controllo qualità

7 ottobre 2022

Primo Inserito (Effettivo)

10 ottobre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • HF-01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Comportamento, Mangiare

Prove cliniche su High-Fat/High-Sugar (HF/HS) Diet

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Madagascar

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi