Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome
Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.
Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Seoul, 대한민국, 07327
- ICAN Nutrition Education and Research
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria: at least three out of five metabolic syndrome components
- waist circumference (WC) >90 cm for men and >80 cm for women
- hypertension (DBP ≥85 and <110 mm Hg)
- hyperglycemia (≥100 mg/dL)
- elevated plasma TG concentrations (≥150 mg/dL)
- decreased plasma HDL-C concentrations (<40 mg/dL for men and <50 mg/dL for women)
Exclusion Criteria:
- the presence of morbid obesity (BMI ≥40)
- the use of any medication for the control of blood pressure, glucose, or lipid metabolism
- a medical history of hypocaloric diet consumption within the past year
- gastrointestinal tract disorders
- post-menopausal women
- smokers
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Walnut-Control
|
45 g of walnut / iso-caloric white bread
|
|
실험적: Control-Walnut
|
45 g of walnut / iso-caloric white bread
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
changes of waist circumference
기간: after 16 weeks of daily walnut consumption
|
Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood triglyceride level
기간: after 16 weeks of daily walnut consumption
|
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood high-density lipoprotein cholesterol levels
기간: after 16 weeks of daily walnut consumption
|
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood pressure
기간: after 16 weeks of daily walnut consumption
|
Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
|
after 16 weeks of daily walnut consumption
|
|
changes of blood glucose level
기간: after 16 weeks of daily walnut consumption
|
Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
|
after 16 weeks of daily walnut consumption
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
changes of total cholesterol level
기간: after 16 weeks of daily walnut consumption
|
Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum apolipoprotein B level
기간: after 16 weeks of daily walnut consumption
|
Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum adiponectin level
기간: after 16 weeks of daily walnut consumption
|
Blood adiponectin (ug/mL) levels were measured using ELISA.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum leptin level
기간: after 16 weeks of daily walnut consumption
|
Blood leptin (ug/mL) levels were measured using ELISA.
|
after 16 weeks of daily walnut consumption
|
|
changes of serum insulin level
기간: after 16 weeks of daily walnut consumption
|
Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.
|
after 16 weeks of daily walnut consumption
|
|
changes of low-density lipoprotein cholesterol level
기간: after 16 weeks of daily walnut consumption
|
Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
|
공동 작업자 및 조사자
간행물 및 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. .
대사 증후군에 대한 임상 시험
-
Istanbul Medipol University Hospital완전한
-
Icahn School of Medicine at Mount SinaiNational Institute on Deafness and Other Communication Disorders (NIDCD)완전한
-
Beijing Friendship Hospital모병
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Basaksehir Cam & Sakura Şehir Hospital완전한
-
Duke Street Bio Ltd모병Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Metastases)스페인, 프랑스, 헝가리, 미국
-
University Hospital, Basel, Switzerland아직 모집하지 않음
-
China Medical University Hospital알려지지 않은
-
Wolfson Medical Center빼는Ovarian Hyperstimulation Syndrome(OHSS)의 위험 감소를 위한 Coasting에 대한 GnRH 길항제의 증량 투여
food에 대한 임상 시험
-
International Centre for Diarrhoeal Disease Research...Washington University School of Medicine모병
-
Purdue University완전한
-
Montefiore Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한
-
The Hospital for Sick ChildrenRyerson University모병
-
Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)모병
-
International Centre for Diarrhoeal Disease Research...Washington University School of Medicine알려지지 않은영양물 섭취 | 미생물군 | 보완 식품방글라데시
-
South Dakota State UniversityUniversity of Missouri-Columbia; Ohio State University; Michigan State University; Purdue University 그리고 다른 협력자들완전한
-
University of California, Los AngelesAga Khan University아직 모집하지 않음영양실조, 아동 | 어린 시절의 심각한 급성 영양실조 | 신경인지, 어린이파키스탄
-
International Centre for Diarrhoeal Disease Research...Washington University School of Medicine모병영양물 섭취 | 미생물군 | 보완 식품방글라데시