Clinical trial NCT06752967: Hormonal Control of Energy and Macronutrient Intake in Obesity (MEMORY)
Official title: Hormonal Control of Energy and Macronutrient Intake in Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Normal Weight
Overweight
Keywords: ad libitum buffet
Food preferences
Macronutrient
Appetite
Appetite hormones
FGF21
Glucagon
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: University of Leeds
name: University of Copenhagen
First posted: 2024-12-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in energy intake from sweet tasting carbohydrates.
timeFrame: Measured after meal consumption at t=150 min
Secondary outcomes:
measure: Difference in self-reported energy intake
timeFrame: Measured 24-hours after test visits
measure: Difference in energy intake from fat
timeFrame: Measured after meal consumption at t=150 min
measure: Difference in energy intake from sweet tasting carbohydrates.
timeFrame: Measured after meal consumption at t=150 min
measure: Difference in energy intake from protein
timeFrame: Measured after meal consumption at t=150 min
measure: Food choice
timeFrame: Measured during test visits (T=-60 min and T=120 min)
measure: Food attention
timeFrame: Measured during test visits (T=-60 min and T=120 min)
measure: Food reaction time
timeFrame: Measured during test visits (T=-60 min and T=120 min)
measure: Explicit liking
timeFrame: Measured during test visits (T=-60 min and T=120 min)
measure: Implicit wanting
timeFrame: Measured during test visits (T=-60 min and T=120 min)
measure: Explicit wanting
timeFrame: Measured during test visits (T=-60 min and T=120 min)
measure: Unspecified exploratory outcome
timeFrame: Measured during test visits (T=-60 min and T=120 min)
measure: Subjective appetite sensations
timeFrame: 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)
measure: Difference in plasma FGF21
timeFrame: 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)
measure: Difference in plasma glucagon levels
timeFrame: 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)
measure: Metabolites
timeFrame: 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)
measure: Hormones
timeFrame: 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)
measure: Biomarkers
timeFrame: 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)
measure: Electrolytes
timeFrame: 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)
measure: Inflammatory markers
timeFrame: Measured at fasted state (time = -60 min) during screening and both test visits (time = -60 min)
measure: Markers of liver function
timeFrame: Measured at fasted state (time = -60 min) during screening and both test visits (time = -60 min)
measure: Difference in self-reported energy intake
timeFrame: Measured 24-hours after test visits
measure: Difference in energy intake from fat
timeFrame: Measured after meal consumption at t=150 min
measure: Difference in energy intake from protein
timeFrame: Measured after meal consumption at t=150 min
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Jonas S Salling Quist, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: