Hormonal Control of Energy and Macronutrient Intake in Obesity (MEMORY) (MEMORY)

April 23, 2026 updated by: Steno Diabetes Center Copenhagen

Hormonal Control of Energy and Macronutrient Intake in Obesity

The overall aim of the MEMORY study is to examine the concept of 'food memory' - how specific macronutrient compositions influence subsequent food preference and intake, and whether this differs across the BMI range from normal weight to obesity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

45 people (age 18-45 years old) with normal weight (BMI between 18.5-24.9 kg/m^2, n=15), overweight (BMI between 25-29.9 kg/m^2, n=15), and obesity (BMI above 30 kg/m^2, n=15) will participate in this randomized cross-over study. Participants will complete one screening visit and two test visits.

During their test visits participants will be served a liquid meal consisting of either carbohydrate (sucrose) or protein (whey protein) diluted in water and sugar-free cordial mix for flavor. Participants will be served either carbohydrate or protein at their first visit and the opposite at their second visit in random order. The test visits will include clinical assessment (body weight, body composition, and blood pressure); Blood samples; Visual analogue scales for assessment of subjective appetite; Ad libitum buffet for assessment of energy intake. Participants will complete the Steno Biometric Food Preference Task (SBFPT), a computerized task measuring food choice, explicit liking, and implicit and explicit wanting with concomitant biometric measurements.

Time: -60 minutes (fasting), 0 minutes (liquid test meal), 150 minutes (ad libitum test buffet).

Descriptive data will be collected at the screening visit and will include body weight (kg); BMI, kg/m^2; Fasting blood samples; Urine sample (future research); Adipose tissue biopsy (future research). Participants will also answer questionnaires regarding Socioeconomic status (SES), Control over eating (CoEQ), Health and wellbeing (SF-36), physical activity (international physical activity ((IPAQ)), and chronotype (morningsness/eveningsness ((MEQ)).

The specific research aims are:

  1. To investigate whether intake of high-sucrose or high-protein affects subsequent food sensory-specific preference and different food intake from an ad libitum buffet, and whether this differs between individuals across the BMI range from normal weight to obesity.

  2. To investigate whether the plasma FGF21 and glucagon responses:

    1. Differ between the above-mentioned macronutrient compositions,
    2. Are associated to subsequent food sensory-specific preference and macronutrient intake from an ad libitum buffet, and
    3. Differ between individuals across the BMI range from normal weight to obesity.

  3. To investigate whether the postprandial responses of well-known appetite-related hormones, as well as unexplored metabolites and proteins:

    1. Differ between the above-mentioned macronutrient compositions,
    2. Are associated to subsequent food sensory-specific preference and macronutrient intake from an ad libitum buffet, and
    3. Differ between individuals across the BMI range from normal weight.
  4. To identify new biomarkers facilitating patient stratification and optimize future treatment of obesity.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Denmark
      • Herlev, Denmark, Denmark, 2730
        • Recruiting
        • Steno Diabetes Center Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-45 years
  • For women: Regular menstruation
  • BMI-range 18.5-39.9 kg/m^2

Exclusion Criteria:

  • Not able or willing to eat or drink the test meals because of e.g., allergy or intolerance
  • Daily smoking
  • For women: Pregnancy / planned pregnancy (within the study period) / lactating
  • Self-reported history of an eating disorder
  • Self-reported weight change (kg) within two months prior to inclusion
  • HbA1c ≥48 mmol/mol
  • Treatment with antidepressants
  • Alcohol/drug abuse or in treatment with disulfiram (antabus) at time of inclusion
  • Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal, or psychiatric disease; diabetes or other endocrine disease; immunosuppression
  • Current treatment with medication which significantly affect appetite or energy balance (e.g., GLP-1 receptor agonists)
  • Bariatric surgery
  • Unable to understand the informed consent and the study procedures
  • Concomitant participation in intervention studies
  • Participant's withdrawal of the informed consent
  • Other safety concerns - judged by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein liquid test meal
Liquid test meal high in protein.
Other: High protein liquid test meal
High protein liquid test meal consisting of whey protein, water and sugar-free coadial mix for flavour.
Experimental: Carbohydrate liquid test meal
Liquid test meal high in carbohydrates.
Other: High carbohydrate liquid test meal
High carbohydrate liquid test meal consisting of sucrose, water and sugar-free coadial mix for flavour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in energy intake from sweet tasting carbohydrates.
Time Frame: Measured after meal consumption at t=150 min
The difference in energy intake (E%) from sweet tasting carbohydrates during the ad libitum buffet in response to the high carbohydrate vs. high protein isocaloric liquid test meals.
Measured after meal consumption at t=150 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in self-reported energy intake
Time Frame: Measured 24-hours after test visits
Difference in 24-h self-reported energy intake (KJ) from carbohydrate, protein, and fat and total energy intake in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured 24-hours after test visits
Difference in energy intake from fat
Time Frame: Measured after meal consumption at t=150 min
Difference in energy intake (KJ) from protein during the ad libitum buffet in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured after meal consumption at t=150 min
Difference in energy intake from sweet tasting carbohydrates.
Time Frame: Measured after meal consumption at t=150 min
The difference in energy intake (KJ) from sweet tasting carbohydrates during the ad libitum buffet in response to the high carbohydrate vs. high protein isocaloric liquid test meals.
Measured after meal consumption at t=150 min
Difference in energy intake from protein
Time Frame: Measured after meal consumption at t=150 min
Difference in energy intake (KJ) from protein during the ad libitum buffet in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured after meal consumption at t=150 min
Food choice
Time Frame: Measured during test visits (T=-60 min and T=120 min)
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.
Measured during test visits (T=-60 min and T=120 min)
Food attention
Time Frame: Measured during test visits (T=-60 min and T=120 min)

Measured using eye tracking in response to looking at food pictures during SBFPT.

Includes the following parameters: Gaze: Time spent (ms and %) andrevisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score ˃0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates attention towards the other food images.
Measured during test visits (T=-60 min and T=120 min)
Food reaction time
Time Frame: Measured during test visits (T=-60 min and T=120 min)
Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fatsavoury and low-fat sweet foods) examined from the SBFPT.
Measured during test visits (T=-60 min and T=120 min)
Explicit liking
Time Frame: Measured during test visits (T=-60 min and T=120 min)
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this foodright now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Measured during test visits (T=-60 min and T=120 min)
Implicit wanting
Time Frame: Measured during test visits (T=-60 min and T=120 min)

Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm).

In this frequency-weighted algorithm a positive score indicates a morerapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred. The frequency weighted algorithm isused so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixedmin-max value)
Measured during test visits (T=-60 min and T=120 min)
Explicit wanting
Time Frame: Measured during test visits (T=-60 min and T=120 min)
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Measured during test visits (T=-60 min and T=120 min)
Unspecified exploratory outcome
Time Frame: Measured during test visits (T=-60 min and T=120 min)
Unspecified exploratory outcomes related to the 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the SBFPT.
Measured during test visits (T=-60 min and T=120 min)
Subjective appetite sensations
Time Frame: Measured at specific time points during test visits (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, or sweet. The scale range is 0-100 mm and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before".
Measured at specific time points during test visits (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Difference in plasma FGF21
Time Frame: Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Difference in plasma FGF21 concentrations in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Difference in plasma glucagon levels
Time Frame: Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Difference in plasma glucagon levels in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Metabolites
Time Frame: Measured at fasted state (LDL/HDL, cholesterol, triglycerides, FFA) and to T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min (glucose, FFA)
Concentrations of metabolites including but not limited to: glucose, triglycerides, cholesterol (LDL/HDL), Free-Fatty Acids (FFA) in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured at fasted state (LDL/HDL, cholesterol, triglycerides, FFA) and to T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min (glucose, FFA)
Hormones
Time Frame: Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Concentrations of hormones related to regulation of appetite, glucose and lipid metabolism (including but not limited to: Insulin, glucagon, ghrelin, Glucagon-Like Peptide-1 (GLP-1), Glucose-Dependent Insulinotropic polypeptide (GIP), C-peptide, Peptide YY (PYY),Fibroblast Growth Factor 21 (FGF21), Growth Differentiation Factor 15 (GDF15), Leptin, Cholecystokinin (CCK), Pancreatic Peptide (PP).
Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Biomarkers
Time Frame: Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Circulating biomarkers measured with metabolomics, lipidomics, proteomics
Measured during screening visit and test visit (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Electrolytes
Time Frame: Measured during test visits (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Concentrations of electrolytes including but not limited to: Natrium and Kalium
Measured during test visits (fasted, T=15 min, T=30 min, T=60 min, T= 75 min, T=90 min, T=105 min, T=120 min, T=150 min)
Inflammatory markers
Time Frame: Measured at fasted state (time = -60 min) during screening and both test visits (time = -60 min)
C-Reactive Protein (CRP), assessed from blood samples at all visits
Measured at fasted state (time = -60 min) during screening and both test visits (time = -60 min)
Markers of liver function
Time Frame: Measured at fasted state (time = -60 min) during screening and both test visits (time = -60 min)
Concentrations of enzymes including but not limited to: Alanine Aminotransferase (ALAT), Aspartate Transaminase (ASAT).
Measured at fasted state (time = -60 min) during screening and both test visits (time = -60 min)
Difference in self-reported energy intake
Time Frame: Measured 24-hours after test visits
Difference in 24-h self-reported energy intake (E%) from carbohydrate, protein, and fat and total energy intake in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured 24-hours after test visits
Difference in energy intake from fat
Time Frame: Measured after meal consumption at t=150 min
Difference in energy intake (E%) from protein during the ad libitum buffet in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured after meal consumption at t=150 min
Difference in energy intake from protein
Time Frame: Measured after meal consumption at t=150 min
Difference in energy intake (E%) from protein during the ad libitum buffet in response to the high carbohydrate vs. high protein isocaloric liquid meals.
Measured after meal consumption at t=150 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Collaborators

Novo Nordisk A/S
University of Copenhagen
University of Leeds

Investigators

  • Principal Investigator: Jonas S Salling Quist, MSc, PhD, Steno Diabetes Center Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

June 29, 2026

Study Completion (Estimated)

June 29, 2026

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24048302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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