- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07710898
Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting
Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting Among Prediabetic Individuals
연구 개요
상태
상세 설명
The target population was adults between the ages of 35 and 65 years who are receiving outpatient care at a hospital or clinic with a diagnosis of either mild to moderate hypertension, dyslipidemia or pre-diabetes. Once consent was given, participants were then be randomly assigned to receive the prescribed intervention or act as a control. The intervention period was 12 weeks.
Participants in the experimental groups received date cider vinegar supplementation, with one group additionally following the 5:2 intermittent fasting protocol. The control group received standard dietary advice without vinegar supplementation or fasting intervention. Participants were instructed to follow the assigned intervention daily according to the study protocol. Weekly follow-up visits were conducted to monitor dietary compliance, record self-reported adherence, and assess health outcomes including lipid profile, body weight,and blood pressure. Usual dietary intake was also monitored to ensure consistency and adherence to the intervention.
At baseline, nutritional assessment based on weight and height, BMI, waist circumference, blood pressure, fasting blood glucose, lipid panels (HDL, LDL, total cholesterol, triglycerides), and dietary intake analysis were done. After 12 weeks of intervention all the measurements that were done again to compare the results pre- and post-intervention.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Lahore, 파키스탄
- The University of Lahore
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- The inclusion criterion was target adults with both gender aged 35-65 years.
- Adults with a diagnosis of mild to moderate hypertension
- Mild hypertension (140-159/90-99 mm Hg)
- Moderate hypertension (160-179/100-109 mm Hg)
- Adults having mild to moderate alterations in lipid profile
- Triglycerides: 150 to 499 mg/dL
- LDL-C levels: Mild Alteration (130 to 159 mg/dL) and Moderate Alteration (160 to 189 mg/dL)
- Adults with pre-diabetes (hbA1c= 5.6-6.4%) were used.
- Patients were solicited from hospital.
Exclusion Criteria:
- Any Lactating and pregnant women were not included.
- Any person allergic to citric acid.
- Adults suffering from critical health conditions, including cancer.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Control Group (T 0 )
Participants continued their prescribed conventional medications for hyperglycemia and lipid management without any additional dietary or vinegar intervention for a duration of 3 months.
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The control group received standard dietary advice without vinegar supplementation or fasting intervention.
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실험적: Experimental Group (T 1 )
Participants received Date Cider Vinegar (DCV) for a duration of 3 months.
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Participants were advised to take 15 ml of Date Cider Vinegar (DCV) diluted in 1 cup (250ml) of water 15 minutes before breakfast and dinner daily for a duration of 3 months.
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실험적: Experimental Group (T 2 )
Participants followed 5:2 Intermittent Fasting (two non-consecutive fasting days per week) along with DCV intervention for a duration of 3 months.
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Participants were advised to follow 5:2 Intermittent Fasting (two non-consecutive fasting days per week) along with DCV intervention for a duration of 3 months. 15 ml of DCV was diluted in 1 cup of water and It was taken 15 minutes before breakfast and dinner daily. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body Mass Index
기간: 3 months
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BMI was calculated by dividing weight (in kg) by the square of height (in meters).
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Blood pressure
기간: 3 months
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Blood pressure measurements will be taken using an automated sphygmomanometer, with systolic pressure and diastolic pressure being measured while sitting after a 5-minute rest.
The average of three readings were used for analysis.
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3 months
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Lipid Profile
기간: 3 months
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Total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein cholesterol (HDL-C) levels were measured using enzymatic methods with commercial test kits.
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3 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
당뇨병에 대한 임상 시험
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Fondazione Policlinico Universitario Agostino Gemelli...아직 모집하지 않음비만 | 제2형 당뇨병 | 인슐린 저항성 당뇨병 (Mellitus)
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Bruno BombaciUniversity of Messina; University of Verona, Italy모병
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University Hospital, Bordeaux완전한
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Oregon Health and Science UniversityUniversity of Washington완전한