Overweight and obesity
Conditions
Interventions
Group 1:The subjects will be instructed to partially replace breakfast and lunch.
Group 2:The subjects will be instructed to partially replace breakfast and dinner.
Sponsors
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Generally healthy Chinese male or female, 18-65 years of age, inclusive at Visit 1 (Week -1). 2. BMI >= 24.0 and 85 cm for males and >80 cm for females at Visit 1 (Week -1). 5. Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during test visits. 6. Stable smoking habits within 6 months of Visit 2 (Week 0) and has no plans to change smoking habits during the study period. If a smoker, the subject agrees to abstain from tobacco and nicotine products at least 1 hour prior to and during each test visit. 7. Willing to perform moderate physical activity daily (i.e., 10000 steps walking daily). 8. Willing to maintain current use of vitamins, minerals, and other supplements throughout the trial and agrees to refrain from consuming these the day of test visits. 9. Willing and able to comply with the visit schedule. 10. Willing to follow the study instructions including dietary plan (including 500 kcal reduction of daily total energy intake), lifestyle and physical activity (at least 10000 steps/day) instructions. 11. Has the ability to access WeChat platform via a smartphone, tablet, and/or computer. 12. Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.
Exclusion criteria
Exclusion criteria: 1. Has Type I or Type II diabetes mellitus or fasting blood glucose >= 7 mmol/L (126 mg/dL) or glycosylated hemoglobin >= 6.5% at Visit 1 (Week -1). 2. Has a history of gout or uric acid >1.2 times normal (Male: 4.0-8.5 mg/dL or 0.24 -0.51 mmol/L; Female: 2.7-7.3 mg/dL or 0.16 -0.43 mmol/L). 3. Has participated in a clinical trial within the past 12 months. 4. Had a weight loss or gain > 5% in the 90 days prior to Visit 1 (Week -1). 5. Has a history of bariatric surgery for weight reducing purpose. 6. Has a diagnosed eating disorder or tendencies that may be representative of disordered eating, in the opinion of the Investigator. 7. Has a history or presence of cancer in the prior 5 years, except for non-melanoma skin cancer. 8. Has a health condition that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and laboratory test results at Visit 1 (Week -1) such as AST and ALT>2.5 times normal value (AST: 0-35 units/L or 0-0.58 µKat/L; ALT: 4-36 units/L), LDL-C >1.5 times normal (= 160 mm Hg or diastolic blood pressure >= 100 mm Hg) as defined by the blood pressure measured at Visit 1 (Week -1). One re-test will be allowed on a separate day prior to Visit 2 (Week 0), for subjects with abnormal blood pressure. Subjects who require medication for hypertension must be on a stable dose [defined as no change in dose within 90 days of Visit 2 (Week 0)] and may be enrolled per the Investigators discretion. 13. Use of dietary supplements intended to alter body weight, appetite, and/or satiety within 30 days of Visit 2 (Week 0) or during the course of the study. 14. Use of prescription weight loss medications within 90 days of Visit 2 (Week 0). 15. Participation in weight management program or using other weight management strategies (e.g., DASH diet, Atkins, Intermittent Fasting, Acupuncture, etc.) within 90 days of Visit 2 (Week 0). 16. Use of thyroid hormones therapy or with medical history of thyroid disorders. 17. Use of lipid-lowering drugs within 90 days of Visit 2 (Week 0). 18. Use of antibiotics within 30 days of Visit 2 (Week 0). 19. Has an active infection or sign/symptoms of an infection. Visits will be re-scheduled to allow the subject to be symptom-free of any type of systemic infection for at least 5 days. 20. Premenopausal female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of an approved form of con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| product intakes;SF36 questionnaire;Physical activity;Body circumference;Blood micronutrients level;Lip profiles;3 day food record;sleeping hours;energy expenditure; | — |
Countries
China
Contacts
Public ContactQingya Tang
Xinhua Hospital Aflliated To Shanghai Jiao Tong University School of Medicine
Outcome results
None listed