Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

Exploring the effect of supplementation with daily addition of prebiotic dried chicory root (WholeFiberTM) for 6 weeks on fecal SCFA levels, gut microbial composition and immune cell composition in minimal stage II A melanoma patients following surgical treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

The participant understands the study and can provide written informed consent;

The participant received surgical treatment of an intermediate to high-risk cutaneous melanoma (T2a/N1, T2b, T3a, T3b, T4a, T4b, N0 or N+, M0 stadium without evidence of disease);

Being able to read and speak Dutch;

Disqualifiers

Receiving concurrent adjuvant treatment, adjuvant treatment after the study period is allowed.

Having a medical history that may impact study outcomes, such as a diagnosis of diabetes mellitus type 2, heart disease, renal disease, autoimmune disease;

Any clinically significant or unstable medical disorder involving the gut, including celiac disease, inflammatory bowel disease, short-bowel syndrome or acute/chronic pancreatitis;

Having an ileostomy or colostomy, as this greatly impacts bowel function and gut microbial composition;

Trial design

Design model

Single group

Treatments tested in this trial

  • prebiotic dried chicory root (WholeFiber)

    Other intervention

    Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: prebiotic dried chicory root (WholeFiber)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels

Effect of a high fiber prebiotic vegetable (WholeFiber) for 6 weeks on fecal SCFA levels in intermediate to high-risk cutaneous melanoma patients, with no concurrent adjuvant treatment. HPLC ion chromatography system (Metrohm AG, Herisau, Switzerland) will be used to determine the levels of SCFA. The concentrations of SCFA; butyrate, propionate, and acetate will be measured with a conductivity detector. SCFA will be measured at baseline, halfway intervention and after 6 weeks.

Time frame
6 weeks

Secondary outcomes

1

Discovering the gut microbial composition changes

Discovering the gut microbial composition changes measured in intermediate to high-risk cutaneous melanoma patients with no concurrent adjuvant treatment, after using WholeFiber for 6 weeks. This analysis will be based on whole genome sequencing of fecal samples performed at the UMCG according to standardized protocol.

Time frame
6 weeks
2

Exploring the effect of WholeFiber use

Exploring the effect of WholeFiber use for 6 weeks on immune functioning, stool patterns, fecal calprotectin levels and side effects in this patient group. Peripheral blood mononuclear cells (PBMCs) and bloodplasma will be isolated to determine immune cell composition before and after the intervention period. Fecal calprotectin will be determined using the respective ELISA kit (Thermo Fisher Scientific). Calprotectin is released when neutrophils enter the gut wall and are activated during the inflammatory process. Lastly, eating patterns, fiber intake before the interventional period, stool patterns and side effects will be identified using the Food Frequency Questionnaire, Bristol Stool Scale, Gastrointestinal Symptoms Rating Scale and Health Related Quality of Life questionnaires.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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