Actively Recruiting
Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-06-24
225
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
CONDITIONS
Official Title
Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman aged 18 to 75 years
- Body mass index (BMI) of 28.0 to 45.0 kg/m2
You will not qualify if you...
- History of HIV, hepatitis B or C, or active pulmonary tuberculosis
- Diagnosis of type 1 or type 2 diabetes
- History of malignant tumors
- Serious liver dysfunction or chronic kidney disease
- History of serious cardiovascular or cerebrovascular disease in the past 6 months
- History of severe gastrointestinal diseases or surgery in the past 12 months
- History of Cushing's syndrome, hypothyroidism, acromegaly, or hypothalamic obesity
- Current or recent smoking within 3 months prior to screening
- Taking weight-affecting medications in the last 6 months
- Current participation in weight loss programs or recent significant weight change
- Women who are pregnant or planning pregnancy
- Unable to be followed for 24 months due to health or migration
- Unwilling or unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
H
Huijie Zhang, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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