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A Pilot Study: Snacking, Willpower and Glucose Availability (SWG)

4 février 2016 mis à jour par: University of Colorado, Denver
To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test whether there is a threshold of glucose that will result in improved ease of resistance to problem foods (tested by comparing three different levels of glucose).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Ingestion of 100 calories of glucose during individually pre-determined times of waning dietary self-control will result in improved ease of resistance to problem foods when compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)

Type d'étude

Interventionnel

Inscription (Réel)

37

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Anschutz Health and Wellness Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  1. Females ages 18 - 65 years.
  2. Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
  3. Have intentionally lost weight in the last year and are seeking to maintain that weight loss or have unintentionally gained weight in the last year and are concerned about it.
  4. Generally healthy.

Exclusion Criteria:

  1. Pregnant or trying to become pregnant.
  2. Diagnosis of type 1 or type 2 diabetes
  3. Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
  4. Current smoker (or has stopped smoking within the last 6 months)
  5. Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents, etc).
  6. Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating disorder)
  7. Current alcohol or drug abuse or dependence
  8. Any medical condition for which daily snacking of such problem foods would be inadvisable (i.e.: a subject with hypertension advised to avoid sodium).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Sequence 1 (D-B-A-C)
100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
Complément alimentaire: Sequence 1
100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
Comparateur actif: Sequence 2 (A-D-C-B)
Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
Complément alimentaire: Sequence 2
Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
Comparateur actif: Sequence 3 (C-A-B-D)
50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
Complément alimentaire: Sequence 3
50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
Comparateur actif: Sequence 4 (B-C-D-A)
10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
Complément alimentaire: Sequence 4
10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Responses to the Control of Eating Questionnaire
Délai: 4 weeks

Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome.

Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).
4 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.
Délai: 4 weeks

Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.

Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
4 weeks
Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.
Délai: 4 weeks
Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
4 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Colorado, Denver

Collaborateurs

Johnson & Johnson

Les enquêteurs

  • Chercheur principal: James O Hill, PhD, Anschutz Health and Wellness Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2014

Achèvement primaire (Réel)

1 janvier 2015

Achèvement de l'étude (Réel)

1 février 2015

Dates d'inscription aux études

Première soumission

2 octobre 2014

Première soumission répondant aux critères de contrôle qualité

6 octobre 2014

Première publication (Estimation)

7 octobre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 mars 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 février 2016

Dernière vérification

1 février 2016

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 14-1485

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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