RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Lab4p Probiotic Consortium for Impaired Glucose Tolerance (Prediabetes)

This 12-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight and obese adults aged 18 to 40. Seventy you would be randomly assigned to receive either Lab4P or a dummy treatment (placebo).

Official registry: https://clinicaltrials.gov/study/NCT07073781 · Leeds Beckett University · enrollment listed as 70

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Lab4p Probiotic Consortium, or Placebo. The registry lists allocation as randomized. This 12-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight and obese adults aged 18 to 40.

They plan to enroll about 70 people at Leeds. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Double-Blind, Placebo-Controlled Exploratory Trial Of Daily Lab4P Probiotic Supplementation For Cognitive Performance And Metabolic Regulation In Young Adults With Overweight Or Obesity

Interventions: Lab4p Probiotic Consortium, Placebo

Primary outcome (registry wording): Verbal Memory Performance

Who it is for (from inclusion criteria)

Ages 18 Years to 40 Years
Self-reported normal sleep patterns, with no history of diagnosed sleep disorders
Willing and able to comply with study procedures, including fasting and oral glucose tolerance testing (OGTT)
Non-smoker at screening, with no regular tobacco use in the preceding six months
English proficiency equivalent to that of a native speaker

Who the registry excludes

Current or past diagnosis of diabetes mellitus of any type. Fasting plasma glucose ≤3.9 or ≥7.0 mmol/L at screening. Diagnosed sleep disorder. History of bariatric surgery or other gastrointestinal procedures that may affect glucose absorption or metabolism
Major surgery, significant trauma, systemic infection, or myocardial infarction within six weeks before screening
History of kidney disease, liver disease, low or high blood pressure, or heart disease
History of conditions that may affect food metabolism, including food allergies or gastrointestinal diseases such as irritable bowel syndrome or peptic ulcers
Current or recent use, within four weeks, of medications affecting glucose metabolism or agents that may alter gut microbiota composition or probiotic how well it works, as defined in Section 8.6
History of psychiatric illness, including anxiety or depression. Current use of prescription or over-the-counter medications, excluding hormonal contraception
Night shift work within 30 days before screening or planned during the study. Pregnancy, breastfeeding, or plans to become pregnant during the study. Known allergy or hypersensitivity to any component of the investigational product or dummy treatment (placebo)

Public study contact (from the registry)

Lewis F Hepburn

+447541333140

l.hepburn3449@student.leedsbeckett.ac.uk

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Leeds Beckett University — Leeds, Greater Manchester, United Kingdom (recruiting)

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FAQ about this NCT record

Is NCT07073781 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07073781?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07073781?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary