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Fasting Mimicking DietFCRC22NCT05384444

Effect of FMD on Colorectal Cancer Patients

A study testing Fasting mimicking diet in people with Fasting Mimicking Diet and Colorectal Cancer, run by Fudan University at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Extensive preclinical evidence suggests that short-term fasting and fasting mimicking diets (FMDs) can protect healthy cells and render cancer cells more vulnerable to chemotherapy and other therapies. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Fasting Mimicking Diet, Colorectal Cancer
What is being tested?
Fasting mimicking diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
602 participants
Where
6 sitesChina
Study dates
8 Jun 2022to 30 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 ~ 80 years old
  • Patients undergoing radical colorectal cancer resection for the first time
  • Preoperative clinical tumor stage III
  • ASA grade I-III grade
  • With BMI 19-32 kg/m2
  • Adequate liver function, adequate renal function and normal cardiac function
  • Willing to participate in the research of the subject and agree to follow up regularly

Who cannot join

  • Evidence of distant metastasis before surgery
  • Before surgery, have received treatment of neoadjuvant chemotherapy
  • Type 1 diabetes or intensive insulin therapy
  • Allergies for FMD content
  • Combined with severe primary diseases such as severe immune system or autoimmune system or long-term using of glucocorticoids or immunosuppressant
  • History of opioid abuse, mental illness or cognitive impairment

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Fudan University Huashan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Fudan University Shanghai Cancer center

    Shanghai, Shanghai Municipality, 200032

  • Fudan University,ZhongShan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Changhai Hospital, Naval Medical University,

    Shanghai, Shanghai Municipality, 200032

  • Shanghai First People's Hospital,Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Tongji Hospital,Tongji University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Effect of Perioperative Dietary Restriction Strategy on Postoperative Recovery and Outcomes of Patients With Colorectal Cancer : a Multicenter Prospective, Randomized, Controlled Study

Extensive preclinical evidence suggests that short-term fasting and fasting mimicking diets (FMDs) can protect healthy cells and render cancer cells more vulnerable to chemotherapy and other therapies. However, fasting is difficult for the old and frail subjects.Therefore, FMDs may be more suitable for postoperative dietary intervention in cancer patients. Colorectal tumors have high glucose consumption, which makes tumor cells very sensitive to changes in nutritional metabolism of the surrounding environment (such as diet restriction / fasting). Previous studies have shown that cyclic FMDs are safe and feasible for cancer patients receiving chemotherapy alone. However, the effects of the FMD in patients under radical surgery for colorectal cancer have not been evaluated so far. This study aims to evaluate the impact of FMDs on postoperative recovery and outcomes of patients with colorectal cancer.

Being tested
Fasting mimicking diet
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fasting mimicking dietOther

    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.

Study groups in NCT05384444
Study groupRoleWhat they receive
Fasting mimicking dietExperimentalThe 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.
Receives: Other: Fasting mimicking diet
regular dietNo interventionregular diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    DFS is defined as the time from randomisation to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. The data of participants without an event will be censored at the date of the last follow-up. Follow-up of survival will be conducted at least every 3 months beginning at 6 months after surgery. Postoperative recurrence or metastasis will be determined on the basis of imaging studies, endoscopic examination, or histopathological assessment of biopsy specimens, with a review also performed by an expert panel.

    Measured: 3 years

Secondary outcomes (12)

  1. Overall Survival

    OS is defined as the time from randomisation to death from any cause. The data of participants who are alive at the end of follow-up will be censored at the date of the last follow-up.

    Measured: 3 years

  2. Weight and BMl

    Weight will be measured to the nearest 0.1 kg using a calibrated electronic scale. Measurements will be performed in the morning after an overnight fast and voiding, with participants in light clothing and without shoes. Height will be measured to the nearest 1 cm without shoes. BMI is calculated as weight divided by height squared (kg/m²). Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.

    Measured: Dietary intervention phase (up to 4 months) and 6 months after surgery

  3. upper arm circumference and waist circumference

    Upper arm circumference and waist circumference will be measured to the nearest 0.1 cm using a non-stretchable tape, in the morning after an overnight fast and with the arms abducted to horizontal. Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.

    Measured: Dietary intervention phase (up to 4 months) and 6 months after surgery

  4. plasma albumin

    Plasma albumin concentration will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in g/L. Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.

    Measured: Dietary intervention phase (up to 4 months) and 6 months after surgery

  5. Nutritional status

    Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment (PG-SGA) score. Higher scores (0-53 scale) indicate a worse nutritional status. Assessments will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.

    Measured: Dietary intervention phase (up to 4 months) and 6 months after surgery

  6. Quality of life (QOL)

    QoL will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Higher total scores for the level 4 rating items, on a scale of 0-112, indicate a worse QoL. Assessments will be performed before surgery, after surgery, and at months 1, 2, 3, 4 and 6 months.

    Measured: Dietary intervention phase (up to 4 months) and 6 months after surgery

  7. Exercise tolerance

    Exercise tolerance will be assessed using metabolic equivalent of task (MET) values. The MET values will be derived from patient-reported daily physical activities and with reference to the 2011 Compendium of Physical Activities Higher scores (1-23 scale) indicate a better exercise tolerance. Assessments will be conducted before surgery, after surgery, and at months 1, 2, 3, 4 and 6 months.

    Measured: Dietary intervention phase (up to 4 months) and 6 months after surgery

  8. Chemotherapy-related toxicities

    In participants receiving postoperative adjuvant chemotherapy, chemotherapy-related toxicities, including haematological, gastrointestinal, neurological and other adverse events, will be recorded after each chemotherapy cycle and graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

    Measured: within 2 weeks after each chemotherapy cycle

  9. insulin-like growth factor 1 (IGF-1)

    IGF-1 will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in ng/mL. Measurements will be conducted before surgery, after surgery, and after dietary intervention .

    Measured: 4 months

  10. Fasting serum glucose (FG)

    FG will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in mmol/L. Measurements will be conducted before surgery, after surgery, and after dietary intervention.

    Measured: 4 months

  11. Fasting insulin (FI)

    FI will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in uU/mL. Measurements will be conducted before surgery, after surgery, and after dietary intervention.

    Measured: 4 months

  12. C-peptide

    C-peptide will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in ng/mL. Measurements will be conducted before surgery, after surgery, and after dietary intervention.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start8 Jun 2022
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Concealed allocation: the statisticians formulate the randomization scheme and generates the random number.
Masking
None (open label)
Enrolment
602 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384444
Sponsor's protocol ID
B2020-063(2)
Acronym
FCRC22
Status last verified
Jun 2026
First submitted
13 Apr 2022
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo M, Sun Z, Zhong Z, Hu H, Qiu Y, Liu S, Yimin N, Tong C, Liang F, Ji C, Xu J, Deng X, Miao C. Effects of a fasting-mimicking diet on long-term prognosis in patients with colorectal cancer undergoing radical resection: protocol for a multicentre, prospective, randomised controlled trial. BMJ Open. 2026 Jul 9;16(7):e121738. doi: 10.1136/bmjopen-2026-121738.

    PubMed 42425570

Questions about this trial

What is this clinical trial studying?

A study testing Fasting mimicking diet in people with Fasting Mimicking Diet and Colorectal Cancer, run by Fudan University at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05384444, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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