NCT06017661

Brief Summary

The aim of the study is to demonstrate, under clinical conditions, the effectiveness of the standard product 'Nutridrink' enriched with a mixture of plant extracts rich in polyphenolic compounds in the aspect of supporting the recovery of oncology patients undergoing surgical resection of tumours.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

September 29, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

August 24, 2023

Last Update Submit

September 28, 2023

Conditions

Immunomodulation

Keywords

chokeberryNutridrinkimmunomodulationtumor resection

Outcome Measures

Primary Outcomes (4)

  • SOD level

    Comparison of SOD level

    Baseline, 3 weeks, 6 weeks

  • GSH level

    Comparison of GSH level

    Baseline, 3 weeks, 6 weeks

  • IL-6 level

    Comparison of IL-6 level

    Baseline, 3 weeks, 6 weeks

  • IL-8 level

    Comparison of IL-8 level

    Baseline, 3 weeks, 6 weeks

Secondary Outcomes (1)

  • Patients' quality of life

    Baseline, 3 weeks, 6 weeks

Study Arms (2)

Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds

EXPERIMENTAL

Group of 15 patients undergoing surgical resection of tumour

Dietary Supplement: Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds

Nutridrink Skin Repair

ACTIVE COMPARATOR

Group of 15 patients undergoing surgical resection of tumour

Dietary Supplement: Nutridrink Skin Repair

Interventions

Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compoundsDIETARY_SUPPLEMENT

2 times a day

Nutridrink Skin Repair with a mixture of plant extracts rich in polyphenolic compounds
Nutridrink Skin RepairDIETARY_SUPPLEMENT

2 times a day

Nutridrink Skin Repair

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men, 18-80 years old
  • Patients diagnosed with resectable gastrointestinal tract cancer undergo the resection procedure no later than one month after being enrolled in the study
  • Signed informed consent

You may not qualify if:

  • Intake of supplements containing plant extracts, polyphenols or anthocyanins
  • Participation in another clinical trial
  • Inability to consume the investigational product in liquid form as medication/placebo
  • Women who are pregnant, planning to become pregnant during the study or breastfeeding
  • Autoimmune disease, severe liver dysfunction, inflammatory bowel disease, tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation
  • Hypersensitivity/allergy to any of the ingredient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniwersyteckie Centrum Kliniczne, Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólne

Gdansk, 80-214, Poland

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

September 1, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

September 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)