NCT06250166

Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: National Cancer Institute, Malaysia · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. The main questions to answer are: 1. What are the current eating trends in colorectal cancer patients? 2. What are the common perceptions of adopting a plant-based diet in colorectal cancer? 3. Does iPLANT diet plan improve nutritional indices of colorectal cancer patients? 4. Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status? Participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. Intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling. The researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.

Conditions

• Colorectal Cancer
• Nutrition Poor
• Gastrointestinal Complication
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	iPLANT diet plan and diet counselling	A diet plan which mainly consists of plant-based food will be designed based on participants' energy and protein needs. The counselling covers (1) guidance to achieve energy and protein requirement (2) advice on food to be included in iPLANT diet plan (Mediterranean diet: increase intake of fish and legumes; moderate intake of eggs, dairy, nuts, poultry; limit intake of red meat).
BEHAVIORAL	Usual diet counselling	General dietary advices on how to improve oral intake and maintain healthy weight will be provided.

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-02-08
• Last updated: 2024-02-28

Locations

2 sites across 1 country: Malaysia