Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Study Overview
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Brief Summary
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An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

Official Title
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Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Conditions
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Scleroderma, Gastroparesis

Intervention / Treatment
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* Device: transcutaneous electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No any systemic diseases; no scleroderma; no history of gastrointestinal surgery; no dyspeptic symptoms during the past 2 weeks; not taking any medications except contraceptives during the past 2 weeks; age 18 and older. Exclusion Criteria: History of any systemic diseases or surgeries; allergic to adhesives; pregnancy; unable to sign the consent form.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: scleroderma patients-0<br>for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial). | Device: transcutaneous electroacupuncture<br>* Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions<br>* Other names: TEA;|
| Experimental: scleroderma patient-1<br>for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used. | Device: transcutaneous electroacupuncture<br>* Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions<br>* Other names: TEA;|
| Experimental: scleroderma patients-2<br>for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used. | Device: transcutaneous electroacupuncture<br>* Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions<br>* Other names: TEA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | On the first visit; The validated UCLA SCTC GIT2.0 (University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation | 1 day | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | On the second visit; The validated University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0 (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation | 28 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | On the third visit; The validated UCLA SCTC GIT2.0 (University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation | 42 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | The validated UCLA SCTC GIT2.0 (University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation | 70 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms | 1 day | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms | 28 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms | 42 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms | 70 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | SF-36 questionnaire will be used to assess general quality of life | 1 day | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | SF-36 questionnaire will be used to assess general quality of life | 28 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | SF-36 questionnaire will be used to assess general quality of life | 42 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | SF-36 questionnaire will be used to assess general quality of life | 70 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | a validated method including 9 symptoms will be used to assess GI symptoms | 1 day | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | a validated method including 9 symptoms will be used to assess GI symptoms | 28 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | a validated method including 9 symptoms will be used to assess GI symptoms | 42 days | 
| effect of TEA on symptoms in Systemic Sclerosis (SSc) patients | a validated method including 9 symptoms will be used to assess GI symptoms | 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of TEA on gastric motility | visit 1 in acute phase; gastric slow waves recording | 1 week | 
| effects of TEA on gastric motility | visit 2 in acute phase; gastric slow waves recording | 2 weeks | 
| effects of TEA on gastric motility | visit 3 in acute phase; gastric slow waves recording | 3 weeks | 
| effects of TEA on gastric motility | visit 4 in acute phase; gastric slow waves recording | 4 weeks | 
| effects of TEA on autonomic function | visit 1 in acute phase; heart rate variability recording | 1 week | 
| effects of TEA on autonomic function | visit 2 in acute phase; heart rate variability recording | 2 weeks | 
| effects of TEA on autonomic function | visit 3 in acute phase; heart rate variability recording | 3 weeks | 
| effects of TEA on autonomic function | visit 4 in acute phase; heart rate variability recording | 4 weeks | 
| effects of TEA on gastric motility | visit 1 in chronic phase; gastric slow waves recording | 1 day | 
| effects of TEA on gastric motility | visit 2 in chronic phase; gastric slow waves recording | 28 days | 
| effects of TEA on gastric motility | visit 3 in chronic phase; gastric slow waves recording | 42 days | 
| effects of TEA on gastric motility | visit 4 in chronic phase; gastric slow waves recording | 70 days | 
| effects of TEA on gastric motility | visit 1 in chronic phase; breath test will be used to assess gastric emptying | 1 day | 
| effects of TEA on gastric motility | visit 2 in chronic phase; breath test will be used to assess gastric emptying | 28 days | 
| effects of TEA on gastric motility | visit 3 in chronic phase; breath test will be used to assess gastric emptying | 42 days | 
| effects of TEA on gastric motility | visit 4 in chronic phase; breath test will be used to assess gastric emptying | 70 days | 
| effects of TEA on autonomic function | visit 1 in chronic phase; heart rate variability recording | 1 day | 
| effects of TEA on autonomic function | visit 2 in chronic phase; heart rate variability recording | 28 days | 
| effects of TEA on autonomic function | visit 3 in chronic phase; heart rate variability recording | 42 days | 
| effects of TEA on autonomic function | visit 4 in chronic phase; heart rate variability recording | 70 days | 
| effects of TEA on autonomic function | visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function | 1 day | 
| effects of TEA on autonomic function | visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function | 28 days | 
| effects of TEA on autonomic function | visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function | 42 days | 
| effects of TEA on autonomic function | visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function | 70 days | 
| effects of TEA on autonomic function | baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 1 day | 
| effects of TEA on autonomic function | baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 28 days | 
| effects of TEA on autonomic function | baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 42 days | 
| effects of TEA on autonomic function | baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 70 days | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 1 day | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 28 days | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 42 days | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 70 days | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 1 day | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 28 days | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 42 days | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function. | 70 days | 
| effects of TEA on autonomic function | baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 1 day | 
| effects of TEA on autonomic function | baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 28 days | 
| effects of TEA on autonomic function | baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 42 days | 
| effects of TEA on autonomic function | baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 70 days | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 1 day | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 28 days | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 42 days | 
| effects of TEA on autonomic function | 30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 70 days | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 1 day | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 28 days | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 42 days | 
| effects of TEA on autonomic function | 60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function. | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; vasoactive intestinal peptide (VIP) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; vasoactive intestinal peptide (VIP) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; vasoactive intestinal peptide (VIP) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; vasoactive intestinal peptide (VIP) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; vasoactive intestinal peptide (VIP) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-10 (IL-10) | day 1 | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-10 (IL-10) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-10 (IL-10) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-10 (IL-10) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-10 (IL-10) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-10 (IL-10) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-10 (IL-10) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-10 (IL-10) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-10 (IL-10) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-10 (IL-10) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-10 (IL-10) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-10 (IL-10) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interferon α(IFNα) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interferon α(IFNα) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interferon α(IFNα) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interferon α(IFNα) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interferon α(IFNα) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interferon α(IFNα) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interferon α(IFNα) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interferon α(IFNα) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interferon α(IFNα) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interferon α(IFNα) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interferon α(IFNα) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interferon α(IFNα) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-1 beta (IL-1β) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-1 beta (IL-1β) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-1 beta (IL-1β) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-1 beta (IL-1β) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-1 beta (IL-1β) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-1 beta (IL-1β) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-1 beta (IL-1β) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-1 beta (IL-1β) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-1 beta (IL-1β) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-1 beta (IL-1β) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-1 beta (IL-1β) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-1 beta (IL-1β) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-6 (IL-6) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-6 (IL-6) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-6 (IL-6) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; interleukin-6 (IL-6) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-6 (IL-6) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-6 (IL-6) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-6 (IL-6) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; interleukin-6 (IL-6) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-6 (IL-6) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-6 (IL-6) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-6 (IL-6) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; interleukin-6 (IL-6) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; tumor necrosis factor alpha(TNFα) | day 1 | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; tumor necrosis factor alpha(TNFα) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; tumor necrosis factor alpha(TNFα) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | baseline before the study; tumor necrosis factor alpha(TNFα) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 30 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 70 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 1 day | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 28 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 42 days | 
| effects of TEA on GI hormones and inflammatory cytokine | 60 minutes after the testing meal; tumor necrosis factor alpha(TNFα) | 70 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous electroacupuncture