NIMA-Colon Cancer Study

NCT07534852 | Recruiting

• 1 other identifier: NIMA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effects of nutritional supplementation and physical activity interventions on recovery, muscle strength, nutritional status, inflammation, and metabolic health in adults with colon cancer undergoing surgery. Patients with colon cancer frequently experience loss of muscle mass, reduced physical function, and nutritional deterioration both before and after surgery, which may adversely affect recovery and quality of life. A key objective of this study is to assess whether a postoperative intervention combining nutritional supplementation with beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, together with a structured physical activity program, can improve muscle strength and functional recovery following colon cancer surgery. This study aims to answer the following questions:

• Does nutritional supplementation with HMB and vitamin D, combined with postoperative physical activity, improve muscle strength and physical function following colon cancer surgery?
• How do nutritional and lifestyle interventions influence nutritional status, gut microbiota composition, and biological markers of inflammation and metabolism during the recovery period?
• Are there differences in recovery outcomes between patients receiving different types of nutritional support, with or without supervised physical activity? Participants will be adults diagnosed with colon cancer who undergo surgical treatment at the Hospital Universitario Virgen de la Victoria in Málaga, Spain. Patients will be recruited prior to surgery and will enter a prehabilitation phase integrated into routine care provided by the Endocrinology and Nutrition Department. During this prehabilitation phase, nutritional status will be assessed and optimized using standard clinical care, including oral nutritional supplementation when indicated. The aim is to improve the patient's condition before surgery. Approximately one month after surgery, once initial postoperative recovery has been completed, participants will enter the intervention and assessment phase (baseline visit). Participants will then be randomly assigned to one of four study groups in a 2×2 factorial design. These groups combine two nutritional strategies (standard care or supplementation with HMB and vitamin D) and two physical activity approaches (supervised exercise or general activity recommendations). The physical activity component, supervised by the Endocrinology and Nutrition team, will be objectively evaluated using an accelerometer-based device. Participants will be followed for approximately six months, with assessments at about 3 and 6 months after the baseline visit. At each visit, participants will undergo:
• Body composition measurements
• Muscle strength and physical performance tests
• Collection of blood, urine, and stool samples
• Questionnaires on health status and quality of life The results of this study will contribute to a more profound understanding of how tailored nutritional strategies and postoperative physical activity may support recovery and functional health in patients undergoing surgery for colon cancer.

Conditions

Colon Cancer

Keywords

Colon cancer; Nutritional supplementation; Physical activity; Muscle strength; Inflammation; Gut microbiota; Beta-hydroxy beta-methylbutyrate supplementation; Vitamin D supplementation; Quality of life; Body composition

Outcome Measures

Primary Outcomes (2)

• Change in phase angle (PhA)

  Phase angle will be assessed by bioelectrical impedance analysis (BIA) as a bioelectrical marker of nutritional and cellular status. Results will be expressed in degrees.

  Baseline (first postoperative visit) and 6 months follow-up

• Change in quadriceps rectus femoris cross-sectional area

  Muscle mass will be assessed using nutritional ultrasound by measuring the cross-sectional area of the quadriceps rectus femoris at a standardized anatomical site (cm²).

  Baseline (first postoperative visit) and 6 months follow-up

Secondary Outcomes (5)

• Plasma concentration of inflammatory and metabolic biomarkers measured by multiplex immunoassay

  From baseline (first postoperative visit), 3 months and 6 months follow-up

• Percentage of DNA methylation in peripheral blood mononuclear cells (PBMCs)by quantitative PCR

  Baseline (first postoperative visit) and 6 months follow-up

• Change in urinary oxylipin concentrations by UHPLC-MS/MS

  Baseline (first postoperative visit) and 6 months follow-up

• Change in relative abundance of gut microbiota taxa

  Baseline (first postoperative visit) and 6 months follow-up

• Change in health-related quality of life score (EORTC QLQ-C30)

  Baseline (first postoperative visit), 3 months, and 6 months follow-up

Study Arms (4)

Standard nutritional care + supervised exercise program

EXPERIMENTAL

Participants receive postoperative standard nutritional care according to routine clinical practice and individualized nutritional assessment. In addition, they participate in a structured supervised exercise program including progressive resistance and functional exercises targeting major muscle groups, adapted to their clinical condition.

Dietary Supplement: Standard hypercaloric-hyperproteic nutritional supplementation; Behavioral: Supervised exercise program

Enhanced nutritional supplementation + non-structured physical activity

EXPERIMENTAL

Participants receive postoperative enhanced nutritional supplementation, including beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, in addition to standard nutritional care based on routine clinical practice and individualized nutritional assessment. Participants also receive general physical activity recommendations according to standard postoperative care without participation in a structured exercise program.

Dietary Supplement: HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium; Behavioral: General physical activity recommendations

Enhanced Nutritional Supplementation + Supervised Physical Activity

EXPERIMENTAL

Participants receive postoperative enhanced nutritional supplementation, including beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, in addition to standard nutritional care based on routine clinical practice and individualized nutritional assessment. In addition, they participate in a structured supervised exercise program including progressive resistance and functional exercises targeting major muscle groups, adapted to their clinical condition.

Dietary Supplement: HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium; Behavioral: Supervised exercise program

Standard nutritional care + general physical activity recommendations

ACTIVE COMPARATOR

Participants receive postoperative standard nutritional care according to routine clinical practice and individualized nutritional assessment. Participants also receive general physical activity recommendations according to standard postoperative care without participation in a structured exercise program.

Dietary Supplement: Standard hypercaloric-hyperproteic nutritional supplementation; Behavioral: General physical activity recommendations

Interventions

Standard hypercaloric-hyperproteic nutritional supplementation DIETARY_SUPPLEMENT

Participants receive a standard oral nutritional supplementation consisting of a hypercaloric and hyperproteic formula designed to support recovery and nutritional status in patients undergoing surgery.

Also known as: Standard Nutrition

Standard nutritional care + general physical activity recommendations; Standard nutritional care + supervised exercise program

HMB-enriched hypercaloric-hyperproteic nutritional supplementation with vitamin D and calcium DIETARY_SUPPLEMENT

Participants receive an oral hypercaloric and hyperproteic nutritional supplementation enriched with β-hydroxy β-methylbutyrate (HMB) and supplemented with vitamin D and calcium. This formulation is designed to support muscle mass preservation and functional recovery in patients undergoing surgical treatment.

Also known as: Enhanced Nutritional Supplementation

Enhanced Nutritional Supplementation + Supervised Physical Activity; Enhanced nutritional supplementation + non-structured physical activity

Supervised exercise program BEHAVIORAL

Participants follow a structured and supervised physical activity program including resistance exercises and functional training. Physical activity levels are periodically monitored using wearable activity devices.

Also known as: Supervised Physical Activity

Enhanced Nutritional Supplementation + Supervised Physical Activity; Standard nutritional care + supervised exercise program

General physical activity recommendations BEHAVIORAL

Participants receive general recommendations for physical activity according to routine clinical practice but do not participate in the structured supervised exercise program.

Also known as: General Physical Activity

Enhanced nutritional supplementation + non-structured physical activity; Standard nutritional care + general physical activity recommendations

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years.
• Male and female participants.
• Diagnosis of colon cancer at localized or locally advanced stages (TNM stages I-III).
• Patients scheduled for primary surgical treatment.

You may not qualify if:

• Metastatic disease (stage IV)
• Diagnosis of rectal cancer or tumors involving the rectum
• Prior neoadjuvant chemotherapy or radiotherapy before surgery.
• Presence of synchronous malignant tumors.
• Pregnant or breastfeeding women.
• Presence of severe medical conditions, including acute pancreatitis, severe liver or kidney disease, heart failure, severe pulmonary disease, or peripheral arterial disease affecting the lower limbs.
• Diagnosis of anorexia nervosa or other severe eating disorders.
• Known allergy or intolerance to any nutritional supplements used in the study.
• Medical contraindications to moderate-to-vigorous physical activity.
• Regular participation in high-intensity exercise programs.
• High risk of poor adherence to the study procedures, as determined by the study team.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Motor Activity; Inflammation

Interventions

Vitamin D; Calcium

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Manuel Macías-Gonzalez, PhD

  Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

  PRINCIPAL INVESTIGATOR

• Carolina Muriel-Lopez, PhD

  Hospital Regional de Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Macías-González, PhD.

CONTACT

+34 952 36 76 00; mmacias.manuel@gmail.com

Libia Alejandra Garcia-Flores, PhD.

CONTACT

+34 952 36 76 00; libia.garcia@ibima.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions, participants and care providers are not blinded. Data analysis will be performed using coded group allocation.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of four parallel study groups representing different combinations of nutritional supplementation and physical activity interventions during the postoperative period.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: April 16, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

ES (1)