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临床试验/NCT05382702
NCT05382702已完成不适用

Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders

Ohio University1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2022年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
133
试验地点
1
主要终点
Subjective rating of fullness

研究概览

简要总结

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • medical conditions affect appetite or weight
  • Recent pregnancy or current breastfeeding
  • Dairy, strawberry or honey food allergy
  • Specific phobia, blood-injection-injury type

研究组 & 干预措施

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.

干预措施: Test meal description changed (Other)

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.

干预措施: Test meal description changed (Other)

结局指标

主要结局

Subjective rating of fullness

时间窗: 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" to "Extreme." 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. The 10-minute assessment of fullness will be used in testing fullness as a mediator of the relationship between fear and gastrointestinal distress and the 20 minute assessment will be used for the exploratory serial mediation model.

Peptide YY response

时间窗: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention

Blood will be drawn repeatedly. PYY3-36 values in plasma will be quantified using a commercially available enzyme immunoassay. Area under the curve with respect to increase (AUCi) will be calculated for all time periods to compare between test meal instructions. PYY values 10 minutes after the intervention will be used in mediation models.

Skin conductance

时间窗: -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention

Skin conductance data will be collected using a Biopac Bionomadix EDA System. Difference scores will be computed for both test meals by comparing mean skin conductance level (expressed in log units) over the 10 minute meal period to the 10 minute period before the meal.

Subjective rating of fear

时间窗: -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" to "Extreme." Subjective fear immediately before the meal will be used in mediation models.

Gastrointestinal distress

时间窗: -10 minutes, 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention

Gastrointestinal distress will be the averaged visual analogue scale ratings of "Nausea" and "Stomach Ache" ranging from "Not At All" to "Extreme." 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. The 20-minute assessment of gastrointestinal distress will be used for the hypothesis testing mediators of the relationship between fear and gastrointestinal distress and the 30 minute assessment will be used for the exploratory serial multiple mediation model.

Cholecystokinin response

时间窗: 0 minutes (immediately after the intervention), 10 minutes, 20 minutes, 30 minutes, 60 minutes and 90 minutes post-intervention

Blood will be drawn repeatedly. Cholecystokinin (CCK) values in plasma will be quantified using a commercially available enzyme immunoassay. Area under the curve with respect to increase (AUCi) will be calculated for all time periods to compare between test meal instructions. CCK values 10 minutes after the intervention will be used in mediation models.

Urges to restrict food intake

时间窗: 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.

Subjective Rating of Fear

时间窗: -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

时间窗: -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

时间窗: -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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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