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Recruiting NCT06752967

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

No phase Interventional Obesity Normal Weight Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High protein liquid test meal, High carbohydrate liquid test meal.
Who it may be relevant to
Registry conditions: Obesity, Normal Weight, Overweight. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Hormonal Control of Energy and Macronutrient Intake in Obesity

Overview

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.

Interventions

  • Other High protein liquid test meal
    High protein liquid test meal consisting of whey protein, water and sugar-free coadial mix for flavour.
  • Other High carbohydrate liquid test meal
    High carbohydrate liquid test meal consisting of sucrose, water and sugar-free coadial mix for flavour.

Primary outcome measures

  • Difference in energy intake from sweet tasting carbohydrates. [Time frame: Measured after meal consumption at t=150 min]
Secondary outcome measures (12)
  • Difference in self-reported energy intake [Time frame: 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 from sweet tasting carbohydrates. [Time frame: Measured after meal consumption at t=150 min]
  • Difference in energy intake from protein [Time frame: Measured after meal consumption at t=150 min]
  • Food choice [Time frame: 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)]
  • Food reaction time [Time frame: 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)]
  • Implicit wanting [Time frame: 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)]
  • Unspecified exploratory outcome [Time frame: 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Steno Diabetes Center Copenhagen — Herlev

Identifiers

NCT: NCT06752967 · H-24048302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗