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Food Addiction and Hormone Study

18. Oktober 2016 aktualisiert von: Cynthia Dsauza, Texas Tech University

Food Addition and Hormone Study

The purpose of this exploratory study is to use Electrogastrography (EGG) to measure and compare the gastric myoelectrical activity between persons with food addiction (FA) and a control group. Additionally, this study will explore if differences exist between perceived hunger and satiety and hormone levels related to hunger and satiety in both groups. The comparison of the EGG readings and hormone levels is the next step in furthering our understanding of food addiction and how the physiology - not simply the symptomatology - of FA does or does not relate to weight management.

Studienübersicht

Status

Unbekannt

Bedingungen

Detaillierte Beschreibung

The study will be conducted over 2 days and will consist of psychological assessments as well as EGG measurement (similar to EGG) and blood draws to examine hunger and satiety hormones.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Texas
      • Lubbock, Texas, Vereinigte Staaten, 79409
        • Rekrutierung
        • TTU College of Human Sciences
        • Kontakt:
        • Kontakt:
          • Cynthia Dsauza
          • Telefonnummer: 8067437335

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

men and women 18-65 who are able to come to TTU for testing and meet eligibility criteria

Beschreibung

Inclusion Criteria:

  • Participants will include men and women who identify with weight struggles related to disordered eating and a control sample of people who do not identify with weight issues or disordered eating. Must be able to read and write English

Exclusion Criteria:

  • Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
  • Anyone who is currently pregnant, or lactating
  • Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling- e.g. antibiotics, anti-depressants, obesity medications
  • Report of medical condition or surgical intervention that affects swallowing ability
  • Allergy, aversion, or dislike to any of the meal replacements or snacks offered
  • Previous or current diagnosis of a psychiatric illness such as schizophrenia or any other psychotic disorder listed in the DSM-IV or DSM-5
  • Report of medical conditions that prohibits overnight fasting

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Food Addiction Group
Those participants identified as having food addiction by the Yale Food Addiction Scale.
No Food Addiction Group
Those participants with no identified food addiction

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Electrogastrography (EGG) using Bipoac Systems EGG machine
Zeitfenster: the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC
Skin electrode similar to EKG attached to abdomen and readings taken
the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ghrelin
Zeitfenster: collected via IV catheter over approximately 3 1/2 hours on one day
hormone assay
collected via IV catheter over approximately 3 1/2 hours on one day
Peptide YY
Zeitfenster: collected via IV catheter over approximately 3 1/2 hours on one day
hormone assay
collected via IV catheter over approximately 3 1/2 hours on one day
GLP-1
Zeitfenster: collected via IV catheter over approximately 3 1/2 hours on one day
hormone assay
collected via IV catheter over approximately 3 1/2 hours on one day
Insulin
Zeitfenster: collected via IV catheter over approximately 3 1/2 hours on one day
hormone assay
collected via IV catheter over approximately 3 1/2 hours on one day
Glucose
Zeitfenster: collected via IV catheter over approximately 3 1/2 hours on one day
Blood glucose levels
collected via IV catheter over approximately 3 1/2 hours on one day
The Center for Epidemiologic Studies Depression Scale
Zeitfenster: Day 1-5-10 minutes
Depression will be measured using The Center for Epidemiologic Studies Depression Scale Revised , a 20-item measure of depression that measures nine different symptom groups of depression according to the American Psychiatric Association Diagnostic and Statistical Manual, fourth edition. These symptom groups include Sadness, Loss of Interest, Appetite, Sleep, Thinking/Concentration, Guilt, Tired, Movement, and Suicidal Ideation. Responses regard frequency of symptoms and are given on 5-point Likert-type scale ranging from 0 (Not at all or less than one day) to 4 (Nearly every day for two weeks). Sample items include "My appetite was poor" and "Nothing made me happy." Item responses are summed to calculate a total score of depression that can be used to classify depression severity. This assessment will take approximately 5-10 minutes.
Day 1-5-10 minutes
GAD-7
Zeitfenster: Day 1 5-10 minutes
Anxiety will be measured using the GAD-7 measure used to assess for generalized anxiety disorder and will take less than 5 minutes to complete. The GAD-7 measures anxiety using seven items to assess frequency of anxiety symptoms on which responses are given on a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (Nearly every day). Sample items include "Feeling anxious, nervous, or on edge" and "Becoming easily annoyed or irritable." All items are summed; and higher scores represent higher levels of anxiety and can be used to classify anxiety severity.
Day 1 5-10 minutes
Yale Food Addiction Scale 2.0
Zeitfenster: Day 1 5-10 minutes
The YFAS is a 35-item measure developed to operationalize food addiction by assessing signs of substance-dependence symptoms (e.g., tolerance, withdrawal, loss of control) in eating behavior. The YFAS has shown internal consistency, as well as convergent and incremental validity. The YFAS provides 2 scoring options: a symptom count version and a diagnostic version. To receive a "diagnosis" of FA, it is necessary to report experiencing 3 or more symptoms in the past year and clinically significant impairment or distress. The version of the YFAS used in the current study will measure all items on a Likert scale. In line with YFAS scoring instructions, 5 of the Likert scale items were dichotomized, such that participants who indicated that they had never experienced the symptom were assigned a value of zero, and those reporting ever experiencing the symptom in the past year were assigned a value of 1.
Day 1 5-10 minutes
Power of Food Scale
Zeitfenster: Day 1 5-10 minutes
The Power of Food Scale (PFS) is a 15-item questionnaire on a 5-point Likert scale ranging from 1 (don't agree) to 5 (strongly agree), and it is designed to measure appetite drive towards highly palatable foods through examining appetite-related thoughts, feelings, and motivations
Day 1 5-10 minutes
Multidimensional Body-Self Relations Questionnaire - Appearance Scales
Zeitfenster: Day 1 5-10 minutes
The Multidimensional Body-Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) is a 34 item measure on a five point Likert scale that is made up of five subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale.
Day 1 5-10 minutes
Trait and State Food Cravings Questionnaires
Zeitfenster: Day 1 5-10 minutes
The Trait and State Food Cravings Questionnaire is comprised of two questionnaires that measure state (FCQ-S) and trait (FCQ-T) of food cravings. The FCQ-S is comprised of 15 items, and the FCQ-T is comprised of 21 items.
Day 1 5-10 minutes
Food Preoccupation Questionnaire
Zeitfenster: Day 1 5-10 minutes
The Food Preoccupation Questionnaire (FPQ) is a 26 Likert item questionnaire that measures the frequency and emotionality of thoughts related to food. It is comprised of four subscales: thought frequency as well as positive, negative, and neutral emotional valences.
Day 1 5-10 minutes
Automated Self-Administered (ASA) 24 Hour Recall
Zeitfenster: Day 1 5-10 minutes
The Automated Self-Administered 24 hour Dietary Recall is a web-based tool that enables automated self-administered 24-hour recalls. It was developed by the National Cancer Institute and has been used in over 200 research studies with over 45,000 participants. Response data are secured at the hosting site using industry standard security controls, including firewalls and encryption.
Day 1 5-10 minutes
Resting Metabolic Rate
Zeitfenster: 10 min
participant breathes into mouthpiece of handheld device for 10 minutes
10 min

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Texas Tech University

Ermittler

  • Hauptermittler: Cynthia Dsauza, PhD, Assistant professor

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2016

Primärer Abschluss (Voraussichtlich)

1. November 2016

Studienabschluss (Voraussichtlich)

1. Dezember 2016

Studienanmeldedaten

Zuerst eingereicht

3. Dezember 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Dezember 2015

Zuerst gepostet (Schätzen)

23. Dezember 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

19. Oktober 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Oktober 2016

Zuletzt verifiziert

1. Oktober 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 505490

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

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