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Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

2020년 5월 5일 업데이트: Johns Hopkins University

A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

This pilot study proposes to gain a better understanding of the health benefits of the popular "paleo-diet" in patients with irritable bowel syndrome (IBS) and explore underlying mechanisms of benefit.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

In the proposed study, the primary hypothesis is that, compared with a customary diet, consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in patients with irritable bowel syndrome. Investigators also hypothesize consumption of the Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory markers, and changes in the gut microbiome and microbiologic profiles.

연구 유형

중재적

등록 (실제)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Maryland
      • Baltimore, Maryland, 미국, 21287
        • Johns Hopkins University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
  • Other causes of bowel symptoms excluded to the satisfaction of the Study Team
  • Age at least 18 years at initial screening visit
  • Patients who are able to sign and understand the study's informed consent form
  • Patients able to complete all screening evaluations and procedures

Exclusion Criteria:

  • Patients in inpatient hospital care
  • Severe or refractory bowel or psychological symptoms
  • Current consumption of a Paleolithic diet
  • Known Celiac disease
  • Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
  • Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
  • Patients unable to speak English
  • Inability to obtain informed consent
  • Pregnant or nursing women
  • Any condition, which in the opinion of the investigator, would interfere with study requirements

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Paleolithic Diet
다른: Paleolithic diet
Paleolithic diet
활성 비교기: General Healthful Diet
다른: General Healthful Diet
General Healthful Diet

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Vitality
기간: The change between baseline and 4 weeks (post-intervention).
Vitality as measured on the vitality subscale of the short form health survey (SF36). This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys. The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life? Did you have a lot of energy? Did you feel worn out? Did you feel tired? The lower the score the more disability. The higher the score the less disability.
The change between baseline and 4 weeks (post-intervention).

2차 결과 측정

결과 측정
측정값 설명
기간
Anxiety
기간: The change between baseline and 4 weeks (post-intervention).

Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.

GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Depression
기간: The change between baseline and 4 weeks (post-intervention).

Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire.

PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Activity level
기간: The change between baseline and 4 weeks (post-intervention).
Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise. It is designed to be reliable valid and easy to complete quickly without a need for detailed review. Lower scores indicate less activity and higher scores equal more activity.
The change between baseline and 4 weeks (post-intervention).
Gastrointestinal symptoms
기간: The change between baseline and 4 weeks (post-intervention).

Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale

a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity
기간: The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity as measured by the Visceral Sensitivity Index. Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Overall health status (Short Health Scale)
기간: The change between baseline and 4 weeks (post-intervention).
Overall health status as measured by the Short Health Scale questionnaires. The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).
Overall health status (EQ-5D)
기간: The change between baseline and 4 weeks (post-intervention).
Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
The change between baseline and 4 weeks (post-intervention).

기타 결과 측정

결과 측정
측정값 설명
기간
Intestinal permeability
기간: The change between baseline and 4 weeks (post-intervention).
Change in intestinal permeability as measured by plasma zonulin levels
The change between baseline and 4 weeks (post-intervention).
Change in inflammatory markers
기간: The change between baseline and 4 weeks (post-intervention).
Change in inflammatory markers as measured by serum C-reactive protein levels
The change between baseline and 4 weeks (post-intervention).
Change in stool metabolomics
기간: The change between baseline and 4 weeks (post-intervention).
Change in stool metabolomics as measured by stool metabolite testing.
The change between baseline and 4 weeks (post-intervention).
Change in stool microbiome profile
기간: The change between baseline and 4 weeks (post-intervention).
Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of urine.
기간: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool.
기간: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of saliva.
기간: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of blood.
기간: The change between baseline and 4 weeks (post-intervention).
Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
The change between baseline and 4 weeks (post-intervention).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Johns Hopkins University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 4월 24일

기본 완료 (실제)

2020년 4월 1일

연구 완료 (실제)

2020년 4월 1일

연구 등록 날짜

최초 제출

2017년 1월 18일

QC 기준을 충족하는 최초 제출

2017년 1월 25일

처음 게시됨 (추정)

2017년 1월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 5월 5일

마지막으로 확인됨

2020년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB00082222

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

과민성 대장 증후군에 대한 임상 시험

Paleolithic diet에 대한 임상 시험

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