Feeding and Eating Disorders
Conditions
Brief summary
The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.
Interventions
OTHERTest meal description changed
Using a within-subjects crossover design, on two separate mornings participants will eat yogurt described as 'high fat' and 'low fat.' In actuality, the meals will not differ.
Sponsors
Ohio University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* female * DSM-5 eating disorder * score 16 or higher on the Clinical Impairment Assessment * experience nausea or stomachache after eating at least "sometimes" * 18 to 40 years old * body mass index between 18.5 and 26.5 kg/m2
Exclusion criteria
* medical conditions affect appetite or weight * Recent pregnancy or current breastfeeding * Dairy, strawberry or honey food allergy * Specific phobia, blood-injection-injury type
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Fear | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention | Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes in Visual Analogue Scale ratings of momentary fear ranging from "Not at All (0)" to "Extreme (100)." AUCi was calculated as: (((Fear at -10 minutes)+ (Fear at 0 minutes))\*10/2) + (((Fear at 0 Minutes)+(Fear at +10 minutes))\*10/2) - (Fear at -10 minutes)\*20. A more positive score indicates greater increases in fear over the pre to post meal period. |
| Difference in Average Skin Conductance | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention | Skin conductance data will be collected in microsiemens using a Biopac Bionomadix EDA System during the period before and after the test meal. The difference in average microsiemens will be computed for each test meal using the following equation: (Average activity for the 10 minute meal period) - (average activity for the 10 minutes prior to the meal). A higher difference indicates increased physiological activation during the meal period relative to the pre-meal period. |
| Gastrointestinal Distress | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention | Gastrointestinal distress will be the averaged visual analogue scale ratings of "Nausea" and "Stomach Ache" ranging from "Not At All (0)" to "Extreme (100)." Area under the curve with respect to increase (AUCi) from the 10 minutes period prior to the meal until immediately after the meal will be used to characterize changes gastrointestinal distress. AUCi was calculated as: (((Gastrointestinal distress at -10 minutes)+ (Gastrointestinal distress at 0 minutes))\*10/2) + (((Gastrointestinal distress at 0 Minutes)+(Gastrointestinal distress at +10 minutes))\*10/2) - (Gastrointestinal distress at -10 minutes)\*20. A more positive score indicates greater increases in gastrointestinal distress over the pre to post meal period. |
| Cholecystokinin Response | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention | Blood was drawn repeatedly. Cholecystokinin (CCK) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-069-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((CCK at 0 Minutes)+( CCK at +10 minutes))\*10/2) + (((CCK at 10 Minutes)+( CCK at +20 minutes))\*10/2) + (((CCK at 20 Minutes)+( CCK at +30 minutes))\*10/2) + (((CCK at 30 Minutes)+( CCK at +60 minutes))\*30/2) + (((CCK at+ 60 Minutes)+( CCK at +90 minutes))\*30/2) - (CCK at -10 minutes)\*90. A more positive score indicates greater increases in CCK over the pre to post meal period. |
| Peptide YY Response | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention | Blood was drawn repeatedly. Peptide YY (PYY) values in plasma were quantified in ng/mL using a commercially available enzyme immunoassay (Phoenix Pharmaceuticals EK-059-02). Area under the curve with respect to increase (AUCi) was calculated from the time period immediately before the test meal to 90 minutes after the test meal. AUCi was calculated as: (((PYY at 0 Minutes)+( PYY at +10 minutes))\*10/2) + (((PYY at 10 Minutes)+(PYY at +20 minutes))\*10/2) + (((PYY at 20 Minutes)+( PYY at +30 minutes))\*10/2) + (((PYY at 30 Minutes)+( PYY at +60 minutes))\*30/2) + (((PYY at+ 60 Minutes)+( PYY at +90 minutes))\*30/2) - (PYY at -10 minutes)\*90. A more positive score indicates greater increases in PYY over the pre to post meal period. |
| Subjective Rating of Fullness | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention | Fullness will be the averaged visual analogue scale ratings of "full" and "satiated(satisfied)" ranging from "Not At All (0)" to "Extreme (100)." Area under the curve with respect to increase (AUCi) will be used to characterize changes in fullness from immediately before the test meal to 90 minutes after. AUCi was calculated as: (((Fullness at -10 minutes)+ (Fullness at 0 minutes))\*10/2) + (((Fullness at 0 Minutes)+( Fullness at +10 minutes))\*10/2) + (((Fullness at 10 Minutes)+( Fullness at +20 minutes))\*10/2) + (((Fullness at 20 Minutes)+( Fullness at +30 minutes))\*10/2) + (((Fullness at 30 Minutes)+( Fullness at +60 minutes))\*30/2) + (((Fullness at 60 Minutes)+( Fullness at +90 minutes))\*30/2) - (Fullness at -10 minutes)\*100. A more positive score indicates greater increases in fullness over the pre to post meal period. |
| Urges to Restrict Food Intake | 60 minutes post-intervention | Visual analogue scales will assess momentary "urge to restrict" from "Not At All" (0) to "Extreme" (100). The 60 minute assessment will be used for the exploratory serial mediation model. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine J Forney, PhD
Ohio University
Participant flow
Pre-assignment details
Participants were assessed for potential eligibility via an online screening survey and phone screen. They then completed diagnostic interviews and questionnaires to confirm eligibility. If eligible, participants were then randomized to test meal condition order.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 20.27 age in years STANDARD_DEVIATION 3.557 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 0 Participants |
| Trait gastrointestinal distress | 2.64 Scores on scale STANDARD_DEVIATION 0.708 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 99 |
| other Total, other adverse events | 8 / 83 | 4 / 82 |
| serious Total, serious adverse events | 0 / 99 | 0 / 99 |
Outcome results
None listed