Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora
2021년 9월 21일 업데이트: Yanna Zhu, Sun Yat-sen University
Effects of Diet and Exercise Interventions on Cardiometabolic Risk Markers, Executive Function, and Intestinal Flora in Undergraduate Students: a Randomized Controlled Trial
The purpose of this study is to estimate the effects of diet and exercise interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
연구 개요
상세 설명
In recent decades, unhealthy dietary patterns and insufficiency of physical activity have brought negative effects on human health, such as rapid increasing incidence of obesity, metabolic cardiovascular diseases, and mental disorders.
The first line of prevention and therapy for these diseases is proper diet and lifestyle interventions.
A series of studies conducted in vivo and vitro have shown that high-fiber diets and time-restricted eating present benefits in weight loss, reducing cardiovascular disease risk, and improving cognitive function.
While, there is also a randomized controlled trial do not observe the effects of time-restricted eating on weight loss and decrease of metabolic risks.
Meanwhile, few studies have examined the effects of high-fiber diets or time-restricted eating on executive function.
Additionally, previous studies on high-fiber diets and time-restricted eating focused on middle-aged or elderly populations with some features of metabolic syndrome, while the effects on healthy young populations are unclear.
More importantly, there are a small amount of studies exploring the combined effects of time-restricted eating and physical activity on metabolism and cognitive function.
Therefore, our study is to estimate the effects of diet (high-fiber diets and time-restricted eating) and exercise (rope-skipping) interventions on body weight, cardiovascular metabolic markers, executive function, and intestinal flora among undergraduate students, as well as the underlying mechanisms.
연구 유형
중재적
등록 (예상)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yanna Zhu, M.D
- 전화번호: 86-20-87330663
- 이메일: zhuyn3@mail.sysu.edu.cn
연구 연락처 백업
- 이름: Ying Ding, M.M
- 전화번호: 86-20-87335573
- 이메일: dingy69@mail.sysu.edu.cn
연구 장소
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510080
- 모병
- Department of Maternal and Child Health and Sun Yat-sen Global Health Institute, School of Public Health and Institute of State Governance, Sun Yatsen University
-
연락하다:
- Yanna Zhu, M.D
- 전화번호: 86-20-87330663
- 이메일: zhuyn3@mail.sysu.edu.cn
-
-
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
17년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- First and second year undergraduate students in Sun Yat-sen University.
- BMI≥22 kg/m^2.
- Keeping weight stable for 3 months prior to study start (weight fluctuation <5kg).
- Having the time and volunteering to receive the interventions.
Exclusion Criteria:
- Currently engaged in other weight-loss studies.
- With high blood pressure, diabetes or other cardiovascular diseases.
- With secondary obesity induced by medicine or other diseases.
- Contraindication to exercise.
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Rope-skipping group
Participants would be required to take part in an exercise plan, under the instruction and guidance of professional sports teachers.
|
주 3회 줄넘기 운동(회당 90분, 20분 줄넘기 후 10분 휴식)
운동 팔찌와 스마트 팔찌는 연구 전반에 걸쳐 에너지 소비를 기록하는 데 사용됩니다.
|
|
실험적: Diet intervention group
Participants would be required to take part in a diet plan , including a high-fiber diet and time-restricted eating.
|
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
|
|
실험적: Combined intervention group
Participants will receive both rope-skipping and diet interventions at the same time.
|
주 3회 줄넘기 운동(회당 90분, 20분 줄넘기 후 10분 휴식)
운동 팔찌와 스마트 팔찌는 연구 전반에 걸쳐 에너지 소비를 기록하는 데 사용됩니다.
Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
|
|
간섭 없음: Control group
Participants would be required to maintain existing diet patterns and physical activity levels.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body weight
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Body weight change of participants
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Body fat percentage
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Body fat percentage were measured by body composition analyzers.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Fat mass
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Fat mass (in kg) were measured by body composition analyzers.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Systolic and diastolic blood pressure
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Sitting systolic and diastolic blood pressure were measured with a validated electronic blood pressure monitor (model OMRON,HEM-7124).
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Serum lipid levels
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Serum lipid levels (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) were analyzed by the enzymatic method.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Fasting plasma glucose
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Fasting plasma glucose were analyzed by the glucose oxidase method.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Fasting plasma insulin
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
Fasting plasma glucose were analyzed by the electrochemiluminescence method.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Intestinal flora
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
To measure the change of intestinal flora by analyzing feces genome 16S rDNA.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The executive functions were measured by the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report Form.
Items are rated 1 (never), 2 (sometimes), and 3 (often).
There is no range for a total score.
Raw scale scores are used to generate T-scores.
A reduction in score indicates less impairment.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Change in appetite sensations
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The appetite sensations were measured by the visual analogue scale (VAS).The VAS consisted of 100-mm lines and participants were required to place a vertical mark across the line corresponding best to their feelings of hunger, satisfaction, and fullness, with the scale ranging from 0 (not at all) to 100 (extremely).
Quantification was performed by measuring the distance between the left end of the line and the vertical mark.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
High-Sensitivity C-Reactive Protein (hs-CRP)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum hs-CRP were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Intercellular adhesion molecule-1 (ICAM-1)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum ICAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Tumor necrosis factor alpha (TNF-alpha)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum TNF-alpha were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Chemokine CCL2
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum chemokine CCL2 were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Vascular cell adhesion molecule (VCAM-1)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum VCAM-1 were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Interleukin-6 (IL-6)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum IL-6 were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Interleukin-8 (IL-8)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the IL-8 were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Leptin
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum leptin were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Tau protein
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum tau protein were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Brain-derived neurotrophic factor (BDNF)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum BDNF were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Vascular endothelial growth factor (VEGF)
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
The levels of the serum VEGF were analyzed using the Luminex Human Magnetic Assay kit.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
|
Circulating metabolome
기간: Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
To measure the change of circulating metabolome by LC-MS/MS method.
|
Baseline (1-2 days before the intervention), right after intervention (12 weeks)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Yanna Zhu, M.D, Sun Yat-sen 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)
2021년 4월 2일
기본 완료 (예상)
2022년 12월 31일
연구 완료 (예상)
2023년 2월 28일
연구 등록 날짜
최초 제출
2021년 4월 3일
QC 기준을 충족하는 최초 제출
2021년 4월 6일
처음 게시됨 (실제)
2021년 4월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 21일
마지막으로 확인됨
2021년 9월 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. .