NCT07888257|Recruiting
LIfestyle MEtabotype Study B (LIME-B)
LIME-B
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LIME-B
Sponsor study identifier
interventional
300
1 country
2
Study Start
October 26, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 22, 2026
Actual (reported)October 26, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
βHB response to exogenous βHB supplementation
βHB area under the curve (AUC) from fasting and repeated postprandial blood samples after drink intake, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Time course of βHB concentrations
Fasting concentrations and time course of βHB concentrations at individual time points including derived metrics (e.g., peak concentration, time to peak, rate of change), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Fasting and postprandial glucose and insulin response
Fasting concentrations and postprandial time course of glucose, insulin and C-peptide in repeated blood samples after drink intake, including derived metrics (e.g., incremental area under the curve \[iAUC\], incremental peak, time to peak, amplitude, nadir, rate of change) and indices of insulin sensitivity (e.g., HOMA-IR), compared between drink conditions (βHB vs. placebo) and glycemic groups
Participants receive a single dose of a βHB ester drink (0.3 g/kg body weight) at one of the two module B visits
Carbohydrate drink Participants receive an equicaloric and taste-matched carbohydrate drink (placebo drink) at the other visit of module B
Single oral dose of a βHB ester (0.3 g/kg body weight), consumed fasted during one of the two visits of module B
Single oral dose of an equicaloric and taste-matched dextrose drink.
Freie Universität Berlin, Center for Cognitive Neuroscience Berlin (CCNB)
Berlin, 14195, Germany
German Institute of Human Nutrition
Nuthetal, 14558, Germany
Olga Ramich, Prof. Dr.
German Institute of Human Nutrition Potsdam-Rehbrücke and the Charité - Universitätsmedizin Berlin
Soyoung Q Park, Prof. Dr.
German Institute of Human Nutrition Potsdam-Rehbrücke and the Charité - Universitätsmedizin Berlin
First Submitted
October 15, 2026
First Posted
October 22, 2026
Study Start
October 26, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
3-16 weeks
Concentration of inflammatory markers
Interleukin-6 (IL-6) and hsCRP levels measured in fasting blood samples; IL-6 additionally in postprandial blood samples after drink intake, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Metabolic and stress-responsive hormones
Growth differentiation factor 15 (GDF15), fibroblast growth factor 21 (FGF21) and cortisol concentrations in fasting and postprandial blood samples, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Gut and appetite-regulating hormones
Glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK), ghrelin and leptin concentrations in fasting and postprandial blood samples, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Lipolysis and energy metabolites
Free fatty acids, triglycerides, lactate and amino acids in fasting and postprandial blood samples, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Oxidative stress markers
Oxidative stress markers such as Malondialdehyde and 3-Nitrotyrosine in fasting and postprandial blood samples, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Avoidance behavior
Time spent in less safe areas and exploratory movement in two virtual reality scenarios (elevated platform, dark maze), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Risky decision-making
Choice behavior in a lottery task during fMRI (e.g., proportion of risky choices, risk attitude), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Dual-task performance
Reaction times, accuracy and dual-task costs in an auditory-visual dual-task paradigm, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Heart rate and heart rate variability (HRV)
Heart rate and heart rate variability (HRV) from electrocardiography, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Skin conductance response
Electrodermal activity (EDA) measured via electrodermal activity electrodes, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Respiration rate
Task-based and resting-state respiration rate, measured via a respiration belt pulse (pulse oximetry during MRI), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Pulse
Pulse measured via pulse oximetry during MRI, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Gastric myoelectric activity
Gastric rhythm and power assessed by electrogastrography (EGG), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Brain Structure
Brain morphology (e.g., regional gray matter volume and density) assessed by T1-weighted structural MRI, compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
White matter micro- and macrostructure
White matter micro- and macrostructure assessed by diffusion-weighted imaging (DWI), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Resting-state functional connectivity
Functional connectivity between brain regions assessed by resting-state functional MRI (rs-fMRI), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Task-related brain activity
Brain activity during a risk-based decision-making task (lottery task) assessed by functional MRI (fMRI), compared between drink conditions (βHB vs. placebo) and glycemic groups
3-16 weeks
Module A phenotyping data as predictors, moderators and controls
2 weeks and 3-16 weeks
Body height
3-16 weeks
Body weight
3-16 weeks
Waist and hip circumference
3-16 weeks
Body Mass Index (BMI)
3-16 weeks
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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