Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
602 participants
INTERVENTIONAL
2022-06-08
2025-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fasting mimicking diet
The cyclic FMD diet consists of a 5 day regimen: day 1 diet of the diet supplies \~1000 kcal (10% protein, 56% fat, 34% carbohydrate), day 2-5 are identical in formulation and provide 800 kcal (9% protein, 44% fat, 47% carbohydrate). At least 4 cyclic FMDs will be performed after operation.
Fasting mimicking diet
The fasting mimicking diet consists of a 5 day regimen: day 1 diet of the diet supplies \~1000 kcal (10% protein, 56% fat, 34% carbohydrate), day 2-5 are identical in formulation and provide 800 kcal (9% protein, 44% fat, 47% carbohydrate). At least 4 cyclic FMDs will be performed after operation.
regular diet
regular diet
No interventions assigned to this group
Interventions
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Fasting mimicking diet
The fasting mimicking diet consists of a 5 day regimen: day 1 diet of the diet supplies \~1000 kcal (10% protein, 56% fat, 34% carbohydrate), day 2-5 are identical in formulation and provide 800 kcal (9% protein, 44% fat, 47% carbohydrate). At least 4 cyclic FMDs will be performed after operation.
Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing radical colorectal cancer resection for the first time
3. Preoperative clinical tumor stage III
4. ASA grade I-III grade
5. With BMI 19-32 kg/m2
6. Adequate liver function, adequate renal function and normal cardiac function
7. Willing to participate in the research of the subject and agree to follow up regularly
Exclusion Criteria
2. Before surgery, have received treatment of neoadjuvant chemotherapy
3. Type 1 diabetes or intensive insulin therapy
4. Allergies for FMD content
5. Combined with severe primary diseases such as severe immune system or autoimmune system or long-term using of glucocorticoids or immunosuppressant
6. History of opioid abuse, mental illness or cognitive impairment
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Cancer Hospital, China
OTHER
Huashan Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Tongji Hospital
OTHER
Changhai Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Changhong Miao
Director
Principal Investigators
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Miaomiao Guo, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Meilin Weng, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Fudan University Huashan Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China
Fudan University,ZhongShan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital, Naval Medical University,
Shanghai, Shanghai Municipality, China
Shanghai First People's Hospital,Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital,Tongji University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B2020-063(2)
Identifier Type: -
Identifier Source: org_study_id
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