Hormonal Control of Energy and Macronutrient Intake in Obesity (MEMORY)
NCT ID: NCT06752967
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-12-12
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Protein liquid test meal
Liquid test meal high in protein.
High protein liquid test meal
High protein liquid test meal consisting of whey protein, water and sugar-free coadial mix for flavour.
Carbohydrate liquid test meal
Liquid test meal high in carbohydrates.
High carbohydrate liquid test meal
High carbohydrate liquid test meal consisting of sucrose, water and sugar-free coadial mix for flavour.
Interventions
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High protein liquid test meal
High protein liquid test meal consisting of whey protein, water and sugar-free coadial mix for flavour.
High carbohydrate liquid test meal
High carbohydrate liquid test meal consisting of sucrose, water and sugar-free coadial mix for flavour.
Eligibility Criteria
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Inclusion Criteria
* For women: Regular menstruation
* BMI-range 18.5-39.9 kg/m\^2
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
University of Leeds
OTHER
University of Copenhagen
OTHER
Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Principal Investigators
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Jonas S Salling Quist, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center Copenhagen
Herlev, Denmark, Denmark
Countries
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Central Contacts
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Other Identifiers
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H-24048302
Identifier Type: -
Identifier Source: org_study_id