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Food Addiction and Hormone Study

18 oktober 2016 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

30

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Texas
      • Lubbock, Texas, Förenta staterna, 79409
        • Rekrytering
        • TTU College of Human Sciences
        • Kontakt:
        • Kontakt:
          • Cynthia Dsauza
          • Telefonnummer: 8067437335

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Electrogastrography (EGG) using Bipoac Systems EGG machine
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ghrelin
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 10 min
participant breathes into mouthpiece of handheld device for 10 minutes
10 min

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Texas Tech University

Utredare

  • Huvudutredare: Cynthia Dsauza, PhD, assistant professor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2016

Primärt slutförande (Förväntat)

1 november 2016

Avslutad studie (Förväntat)

1 december 2016

Studieregistreringsdatum

Först inskickad

3 december 2015

Först inskickad som uppfyllde QC-kriterierna

17 december 2015

Första postat (Uppskatta)

23 december 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

19 oktober 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 oktober 2016

Senast verifierad

1 oktober 2016

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 505490

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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