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| ID | Type | Description | Link |
|---|---|---|---|
| R15MH128703 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Fat Yogurt - Low Fat Yogurt | Other | Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3. |
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| Low Fat Yogurt - High Fat Yogurt | Other | Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test meal description changed | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Fear | 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. | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention |
| Difference in Average Skin Conductance | 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. | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention |
| Gastrointestinal Distress | 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. | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention |
| Cholecystokinin Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine J Forney, PhD | Ohio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio University | Athens | Ohio | 45701 | United States |
Data will be shared according to the NIMH Data Sharing Policy (NOT-MH-19-033), including being shared with the NIMH Data Archive.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Fat Yogurt - Low Fat Yogurt | Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3. |
| FG001 | Low Fat Yogurt - High Fat Yogurt | Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Visit 2 (First Test Meal) |
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| Study Visit 3 (Second Test Meal) |
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All randomized participants are reported for baseline analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | High Fat Yogurt - Low Fat Yogurt | Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3. |
| BG001 | Low Fat Yogurt - High Fat Yogurt |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Rating of Fear | 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. | In total, 75 people completed both test meal visits. However, only 68 individuals are included in the analyses of fear. We excluded the data of one participant whose responses suggested she did not attend to item content and the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. One participant's self report data was missing at the -10 minute mark and so AUCi could not be calculated. | Posted | Mean | Standard Deviation | units on scale*minutes | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention |
|
From enrollment to end of Study Visit 3, up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Fat Yogurt | Participants will eat yogurt described as 'high fat' | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal Response to IV Insertion | General disorders | Systematic Assessment | Vasovagal response to IV insertion, as either observed by medical staff (e.g., fainting) or reported by the participant (e.g., nausea) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Forney | Ohio University | 740-593-1085 | forney@ohio.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2022 | Feb 4, 2026 | Prot_SAP_009.pdf |
| ICF | No | No | Yes | Informed Consent Form: Online Screen | Dec 2, 2024 | Dec 17, 2024 | ICF_007.pdf |
| ICF | No | No | Yes | Informed Consent Form: In Person Consent | Dec 2, 2024 | Dec 17, 2024 | ICF_008.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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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. |
| 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention |
| Peptide YY Response | 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. | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention |
| Subjective Rating of Fullness | 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. | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention |
| Urges to Restrict Food Intake | 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. | 60 minutes post-intervention |
| Lost to Follow-up |
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| NOT COMPLETED |
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Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3.
| BG002 | Total | Total of all reporting groups |
| age in years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Trait gastrointestinal distress | Trait gastrointestinal distress was assessed at screening on a 0 from 4 to scale, where 0 was "never" and 4 was "very often." Participants were asked "Please rate how frequently this statement applied to you during the past four weeks, including today. "I felt nauseous or had a stomachache after eating." | Mean | Standard Deviation | Scores on scale |
|
| Description |
|---|
| OG000 | High Fat Yogurt - Low Fat Yogurt | Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3. |
| OG001 | Low Fat Yogurt - High Fat Yogurt | Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3. |
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|
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| Primary | Difference in Average Skin Conductance | 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. | In total, 75 people completed both test meal visits. However, only 52 individuals are included in the analyses of skin conductance activity. We excluded the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. 18 individuals had data excluded due to failure of EDA data collection (e.g., average activity under 1 microseimen at any point). | Posted | Mean | Standard Deviation | Difference in average microseimens | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention |
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| Primary | Gastrointestinal Distress | 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. | In total, 75 people completed both test meal visits. However, only 68 individuals are included in the analyses of fear. We excluded the data of one participant whose responses suggested she did not attend to item content and the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. One participant's self report data was missing at the -10 minute mark and so AUCi could not be calculated. | Posted | Mean | Standard Deviation | units on scale*minutes | -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention |
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| Primary | Cholecystokinin Response | 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. | In total, 75 people completed both test meal visits. However, only 51 individuals are included in the analyses of CCK. We excluded the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. AUCi could not be calculated for three individuals who were missing at least 1 sample. Finally, 16 individuals did not have plasma samples collected due to difficulties placing an IV, an adverse reaction to IV placement, or limited nursing staff availability. | Posted | Mean | Standard Deviation | ng*minute/mL | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention |
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| Primary | Peptide YY Response | 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. | In total, 75 people completed both test meal visits. However, only 51 individuals are included in the analyses of PYY. We excluded the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. AUCi could not be calculated for three individuals who were missing at least 1 sample. Finally, 16 individuals did not have plasma samples collected due to difficulties placing an IV, an adverse reaction to IV placement, or limited nursing staff availability. | Posted | Mean | Standard Deviation | ng*minute/mL | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention |
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| Primary | Subjective Rating of Fullness | 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. | In total, 75 people completed both test meal visits. However, only 64 individuals are included in the analyses of fullness. We excluded the data of one participant whose responses suggested she did not attend to item content and the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. One participant's self-report data was missing at the -10 minute mark and 4 participants were missing data at the 90 minute mark. As a result, AUCI could not be calculated. | Posted | Mean | Standard Deviation | units on scale*minutes | 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention |
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| Primary | Urges to Restrict Food Intake | 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. | In total, 75 people completed both test meal visits. However, only 69 individuals are included in the analysis of urge to restrict. We excluded the data of one participant whose responses suggested she did not attend to item content and the data of 5 individuals those who failed to eat at least 85% of the yogurt test meal at any visit. | Posted | Mean | Standard Deviation | units on scale | 60 minutes post-intervention |
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| 99 |
| 0 |
| 99 |
| 8 |
| 83 |
| EG001 | Low Fat Yogurt | Participants will eat yogurt described as 'low fat' | 0 | 99 | 0 | 99 | 4 | 82 |
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