LIfestyle MEtabotype study b (LIME-B)

NCT ID NCT07888257

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

Summary

Glycemic responses vary significantly among individuals, even when consuming identical foods or meals, but the factors predicting individual glucose responses to food intake remain poorly investigated. The aim of the LIfestyle MEtabotype (LIME) study is to identify lifestyle-related and mechanistic factors which predict individual postprandial glucose fluctuations in individuals with different glycemic status (prediabetes, type 2 diabetes \[T2D\] and absence of prediabetes or T2D), using comprehensive lifestyle characterization and metabolic, molecular and neurocognitive phenotyping. As part of this phenotyping, the LIME study also investigates the role of ketone bodies. Individuals with insulin resistance, prediabetes or T2D often show impaired cerebral glucose utilization. Ketone bodies, such as β-hydroxybutyrate (βHB) may serve as an alternative energy source for the brain. However, how exogenous βHB affects neurocognitive processes and decision-making in individuals with different glycemic status remains poorly understood. This record describes module B of the LIME study. Module B investigates the effects of a single dose of exogenous βHB, compared with a carbohydrate-based placebo drink, on brain structure and function, decision-making behavior and physiological and metabolic responses. Module A comprises a comprehensive lifestyle and metabolic characterization of the same participants and is registered separately as an observational study (NCT07868601). Data from both modules will be integrated in joint analyses.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Overweight or obese (BMI 25-40 kg/m²) * Good knowledge of German * Completion of the LIME screening visit; participants who do not take part in the further assessments of module A \[NCT07868601\] may still participate in module B Participants are classified into three groups based on the screening visit: * Group A (without Prediabetes or Type 2 Diabetes) Criteria: HbA1c \<5.7% and fasting plasma glucose \< 100 mg/dl * Group B (Prediabetes) Criteria: HbA1c 5.7-6.4%, or fasting plasma glucose 100-125 mg/dL * Group C (Type 2 Diabetes) Criteria: HbA1c ≥6.5%, fasting plasma glucose ≥ 126 mg/dl, or existing T2D diagnosis by physician, or T2D diagnosis based on an available result from standardized 75 g oral glucose tolerance test Exclusion Criteria: * Weight changes of more than 5% in the last 3 months * Night shift work * Travel across more than one time zone in the last month before and during study participation * Intensive regular physical activity of more than 2 hours per day * Current pregnancy or breastfeeding * Severe renal, liver or heart disease * Existing or past hematological malignancies, other malignant tumors, unless successfully treated more than 12 months before study start * Severe neurological or psychiatric disorders * Daily alcohol consumption of more than 20 grams or more than 150 grams per week * Use of illicit or legal drugs one week prior to study start and during study participation * Known systemic infections * Type 1 diabetes and rare forms of diabetes * Diabetes treatment with insulin or sulfonylureas or diabetes medication in the absence of manifest type 2 diabetes * Unstable thyroid dysfunction * Blood coagulation disorders or anticoagulation therapy that cannot be interrupted * Medications affecting nutrient absorption * Medications with immunosuppressants or steroids (oral or parenteral) * Current eating disorders, functional or structural digestive disorders or bariatric surgery * Food allergies or intolerances to ingredients of the test meals * Intermittent fasting or calorie-restricted diet four weeks prior to the start of the study or during the study * Ketogenic diet or ketogenic supplements four weeks prior to or during module B * Left-handedness * Severe claustrophobia * Electrical implants or non-removable metallic implants * Concurrent participation in another intervention study * Assessment by the study physician based on medical concerns precluding study participation

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Conditions

The condition(s) this trial relates to.

Ketosis Nutritional and Metabolic Diseases prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Freie Universität Berlin, Center for Cognitive Neuroscience Berlin (CCNB)

    RECRUITING

    Berlin, 14195, Germany

  • German Institute of Human Nutrition

    RECRUITING

    Nuthetal, 14558, Germany

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