NCT05658263 is a EARLY_PHASE1 clinical trial of Standard Diet in Dysbiosis, sponsored by University of Minnesota.

Who is sponsoring NCT05658263?

NCT05658263 is sponsored by University of Minnesota.

What drugs are being tested in NCT05658263?

Interventions in NCT05658263: Standard Diet, BIG MACS Diet.

What condition does NCT05658263 study?

NCT05658263 studies Dysbiosis, Sarcopenia, Colon Cancer.

Is NCT05658263 still recruiting?

NCT05658263 is currently completed. Last updated 13 May 2025.

Last reviewed 2025-05-13 · How we verify

NCT05658263

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet

Completed EARLY_PHASE1 Last updated 13 May 2025

What this trial tests

EARLY_PHASE1 trial testing Standard Diet in Dysbiosis in 14 participants. Completed in 15 August 2024.

Timeline

3 January 2023

Primary endpoint
15 August 2024

15 August 2024

Quick facts

Lead sponsor	University of Minnesota
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	14
Start date	3 January 2023
Primary completion	15 August 2024
Estimated completion	15 August 2024
Sites	1 location across United States

Drugs / interventions tested

Standard Diet — full drug profile →
BIG MACS Diet

Conditions studied

Dysbiosis — all drugs for Dysbiosis →
Sarcopenia — all drugs for Sarcopenia →
Colon Cancer — all drugs for Colon Cancer →

Sponsor

University of Minnesota

Who can join

Adults 25 to 70, any sex, with Dysbiosis or Sarcopenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet will provide participants with increased microbiota accessible carbohydrates (MACs) to support the microbiome and improve outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The advent of precision nutrigeroscience in cancer: from clinic towards molecular biology.
Gao Z, Liu Y, Cui Y, Han Y, et al · · 2026 · cited 2× · PMID 40850675 · DOI 10.1016/j.jare.2025.08.034

Verify or expand the search:

Other trials of Standard Diet

Trials testing the same drug.

NCT07118657 — Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis. · NA · not yet recruiting
NCT06503809 — Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes · NA · recruiting
NCT06044935 — Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate · NA · recruiting
NCT06683430 — High Potassium Diet with Spices and Herbs As Salt Substitute for Lowering Blood Pressure in Older Adults: Study Protocol · NA · completed
NCT03509571 — Ketogenic Diet to Improve Neuro-recovery · NA · recruiting

Other recruiting trials for Dysbiosis

Currently open trials in the same condition.

NCT07148583 — BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months · NA · recruiting
NCT07231003 — The Effect of Glucomannan Powder on Improving Gut Microbiota. · NA · active not recruiting
NCT06877585 — Association Between Fecal Microbiota Composition, Metabolite Concentrations, and Indoxyl Sulfate Levels · recruiting
NCT06872320 — The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease · NA · active not recruiting
NCT06914375 — Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health · NA · active not recruiting

Other University of Minnesota trials

Trials by the same sponsor.

NCT02421497 — MRI Technical Development and Applications in Kidney Disease · not yet recruiting
NCT04100109 — Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic · NA · withdrawn
NCT05454306 — Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures · NA · withdrawn
NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05658263 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 13 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05658263.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing