Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects (POMEcardio)
Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
연구 개요
상태
정황
개입 / 치료
- 건강 보조 식품: Pomegranate extract-first dose-Group A
- 건강 보조 식품: Pomegranate extract-first dose-Group B
- 건강 보조 식품: Pomegranate extract-second dose-Group A
- 건강 보조 식품: Pomegranate extract-second dose-Group B
- 건강 보조 식품: Placebo-first dose-Group B
- 건강 보조 식품: Placebo-first dose-Group A
- 건강 보조 식품: Placebo-second dose-Group B
- 건강 보조 식품: Placebo-second dose-Group A
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Murcia, 스페인, 30107
- UCAM (San Antonio Catholic University from Murcia)
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참여기준
자격 기준
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연구 대상 성별
설명
Inclusion Criteria:
- Aged 40-65 years
- Body mass index (BMI) >27 kg/m2
- Healthy status (no illness in the previous 3-months).
Exclusion Criteria:
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
- Suspected hypersensitivity to pomegranate or any of its components
- Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Pomegranate extract
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
다른 이름들:
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
다른 이름들:
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
다른 이름들:
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
다른 이름들:
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위약 비교기: Placebo
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group B will consume 1 daily capsules of placebo for 3 weeks.
다른 이름들:
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
다른 이름들:
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
다른 이름들:
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
다른 이름들:
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주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in serum oxidized LDL-cholesterol concentration
기간: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on circulating levels of oxidized particles of LDL-cholesterol
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in serum lipids and lipoproteins levels
기간: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in serum sICAM, sVCAM and hsCRP
기간: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in fecal microbiota
기간: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Number of volunteers with adverse events as a measure of safety and tolerability
기간: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in phenolics and derived metabolites in plasma, feces and urine.
기간: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Dr. Juan Carlos Espín, PhD, National Research Council (CEBAS-CSIC, Murcia, Spain)
연구 기록 날짜
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기본 완료 (실제)
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