Cardiometabolic Risk, Executive Function, Intestinal Microbiome
Conditions
Keywords
Dietary Fiber, Time Restricted Feeding, Exercise, Young Adult
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALExercise
Rope-skipping exercise for three times a week (90 minutes each time, and there is a 10 min break after 20 min Rope skipping). Exercise bracelet and smart bracelet would be used to record the energy consumption throughout the study.
BEHAVIORALDiet
Diet interventions include ten-hour time-restricted eating and a high-fiber diet. 1. Participants will be instructed to take food from 7:30 AM until 5:30 PM and completely abstain from caloric intake for the remainder of the day (14 hours fast:10 hours eat). Only noncaloric beverages were permitted outside of the eating widow. 2. According to the dietary recommendation proposed by Chinese Government and the existing dishes in the canteen , participants are instructed to eat following a high-diet recipe weekly from Monday to Friday which includes whole grain wheat rice, vegetables, fruits, and other foods rich in dietary fiber .
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 24 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | Body weight change of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | Fat mass (in kg) were measured by body composition analyzers. |
| Systolic and diastolic blood pressure | 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). |
| Serum lipid levels | 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. |
| Fasting plasma glucose | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | Fasting plasma glucose were analyzed by the glucose oxidase method. |
| Fasting plasma insulin | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | Fasting plasma glucose were analyzed by the electrochemiluminescence method. |
| Intestinal flora | 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. |
| Change in scores on Behaviour Rating Inventory of Executive Functioning-Adult Version (BRIEF-A) | 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. |
| Change in appetite sensations | 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. |
| High-Sensitivity C-Reactive Protein (hs-CRP) | 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. |
| Intercellular adhesion molecule-1 (ICAM-1) | 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. |
| Body fat percentage | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | Body fat percentage were measured by body composition analyzers. |
| Chemokine CCL2 | 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. |
| Vascular cell adhesion molecule (VCAM-1) | 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. |
| Interleukin-6 (IL-6) | 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. |
| Interleukin-8 (IL-8) | 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. |
| Leptin | 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. |
| Tau protein | 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. |
| Brain-derived neurotrophic factor (BDNF) | 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. |
| Vascular endothelial growth factor (VEGF) | 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. |
| Circulating metabolome | Baseline (1-2 days before the intervention), right after intervention (12 weeks) | To measure the change of circulating metabolome by LC-MS/MS method. |
| Tumor necrosis factor alpha (TNF-alpha) | 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. |
Countries
China
Contacts
Primary ContactYanna Zhu, M.D
Backup ContactYing Ding, M.M
Outcome results
None listed