Efficacy of a Natural Ingredient on Blood Pressure (FISTA)
2019년 10월 3일 업데이트: Francisco Javier López Román, Universidad Católica San Antonio de Murcia
Clinical Trial and Randomized Efficacy of a Natural Ingredient on the Arterial Tension of Normother Subjects or With Arterial Hypertension Grade i Without Pharmacological Treatment
Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy.
The subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol.
Later, a statistical analysis will be carried out with the variables measured in the study to obtain results.
연구 개요
연구 유형
중재적
등록 (실제)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Murcia, 스페인, 30107
- Catholic University of Murcia
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Subjects of both sexes between 18-65 years old.
- Systolic blood pressure between 120 and 159 mmHg or diastolic blood pressure between 80 and 100 mm Hg. taken in basal conditions.
- Volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study
Exclusion Criteria:
- In pharmacological treatment of arterial hypertension.
- Subjects with acute diseases.
- Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects.
- Subjected to major surgery in the last 3 months.
- Subjects who stopped smoking in the last 6 months or who intend to quit during the study.
- Subjects with allergies or eating disorders.
- Participation in another study that includes blood extractions or dietary intervention.
- Pregnant woman.
- Subjects whose condition does not make them eligible for the study, according to the researcher.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Ëxperimental
Consumption during 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg. Two capsules a day will be consumed thirty minutes before breakfast for 84 days. |
84 days of consumption
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위약 비교기: Placebo
Consumption during 84 days of saccharose.
Two capsules a day will be consumed thirty minutes before breakfast for 84 days.
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84 days of consumption
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessing a change of blood pressure five times
기간: Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.
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blood pressure is measured with a holter
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Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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body composition
기간: Two densitometries will be performed. One at the beginning of the test, in basal conditions and another at the end of the test after 84 days of taking the product.e beginning and at the end
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Dual X-ray absorptiometry (DEXA)
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Two densitometries will be performed. One at the beginning of the test, in basal conditions and another at the end of the test after 84 days of taking the product.e beginning and at the end
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body composition
기간: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days.
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Bioimpedancetry
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A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days.
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blood samples
기간: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
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Glucidal metabolism and lipid metabolism.
It was measured in milligrams per deciliter.
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Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
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Subjective sensation of product consumption
기간: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
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5-point hedonic scale.
There are five points, being 1 I do not like and 5 I like it a lot.
A scale will be passed through paper.
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Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
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physical activity
기간: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study.
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accelerometer
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An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study.
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Control of dietary intake
기간: A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
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Diet source
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A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
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quality of life questionnaire
기간: The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always.
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questionnaire: WHOQOL-BREF
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The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always.
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Gastrointestinal well-being evaluation
기간: The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product.
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Gastrointestinal quality of life questionnaire.
The subjects have to answer 36 items on a scale of one to five, being 1 all the time and 5 never.
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The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 9일
기본 완료 (실제)
2019년 2월 28일
연구 완료 (실제)
2019년 3월 30일
연구 등록 날짜
최초 제출
2018년 2월 27일
QC 기준을 충족하는 최초 제출
2018년 3월 19일
처음 게시됨 (실제)
2018년 3월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 3일
마지막으로 확인됨
2019년 10월 1일
추가 정보
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. .