Hormonal Control of Energy and Macronutrient Intake in Obesity (MEMORY)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: High protein liquid test meal, High carbohydrate liquid test meal.
- Кому может быть актуально
- Состояния в реестре: Obesity, Normal Weight, Overweight. Базовые параметры: 18 лет — 45 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Hormonal Control of Energy and Macronutrient Intake in Obesity
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое High protein liquid test meal
High protein liquid test meal consisting of whey protein, water and sugar-free coadial mix for flavour. - Другое High carbohydrate liquid test meal
High carbohydrate liquid test meal consisting of sucrose, water and sugar-free coadial mix for flavour.
Первичные конечные точки
- Difference in energy intake from sweet tasting carbohydrates. [Срок оценки: Measured after meal consumption at t=150 min]
Вторичные конечные точки (12)
- Difference in self-reported energy intake [Срок оценки: Measured 24-hours after test visits]
- Difference in energy intake from fat [Срок оценки: Measured after meal consumption at t=150 min]
- Difference in energy intake from sweet tasting carbohydrates. [Срок оценки: Measured after meal consumption at t=150 min]
- Difference in energy intake from protein [Срок оценки: Measured after meal consumption at t=150 min]
- Food choice [Срок оценки: Measured during test visits (T=-60 min and T=120 min)]
- Food attention [Срок оценки: Measured during test visits (T=-60 min and T=120 min)]
- Food reaction time [Срок оценки: Measured during test visits (T=-60 min and T=120 min)]
- Explicit liking [Срок оценки: Measured during test visits (T=-60 min and T=120 min)]
- Implicit wanting [Срок оценки: Measured during test visits (T=-60 min and T=120 min)]
- Explicit wanting [Срок оценки: Measured during test visits (T=-60 min and T=120 min)]
- Unspecified exploratory outcome [Срок оценки: Measured during test visits (T=-60 min and T=120 min)]
- Subjective appetite sensations [Срок оценки: 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)]
Критерии участия
Критерии включения
- Age 18-45 years
- For women: Regular menstruation
- BMI-range 18.5-39.9 kg/m\^2
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Steno Diabetes Center Copenhagen — Herlev
Идентификаторы
NCT: NCT06752967 · H-24048302