Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Whole milk, Nonfat milk.
- Кому может быть актуально
- Состояния в реестре: Obesity, Diabetes, Cardiovascular Diseases. Базовые параметры: 9 лет — 12 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
- США
- 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
Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT
Обзор
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
Подробное описание
Background The optimal type of milk is a topic of much debate. Several recent observational studies indicate that consuming whole (full-fat), compared to reduced-fat milk, is associated with less weight gain and decreased cardiometabolic disease risk. The observed beneficial effect of consuming whole milk on body weight may be due to its greater satiety value, leading to consumption of fewer calories from other lower quality (e.g., sugary) foods. Mechanistic studies indicate that substitution of carbohydrate with certain saturated fatty acids in milk increases low-density lipoprotein cholesterol (LDL-C). However, this increase has been attributed to large, buoyant particles that are less atherogenic than small, dense particles; is accompanied by an increase in high-density lipoprotein cholesterol (HDL-C); and may not elevate overall risk compared to carbohydrate.
Specific Aims and Hypotheses
* To examine the effects of milk consumption on body composition (Aim #1) and cardiometabolic disease risk factors (Aim #2). Primary Hypothesis. Consuming whole milk will result in less weight gain compared to consuming nonfat milk. Secondary hypothesis. Consuming whole milk will decrease cardiometabolic disease risk compared to consuming nonfat milk. * To explore the effects of milk consumption on dietary quality (Aim #3). Exploratory hypothesis. Consuming whole milk will improve overall dietary quality by displacing lower quality foods compared to consuming nonfat milk, particularly among children with low baseline dietary quality. * (Ancillary Study) To evaluate the effects of milk consumption on risk and prevalence of dental caries.
Design Randomized Controlled Trial. Participants (N=200, aged 9 to 12 years, BMI≥75th percentile) will be randomly assigned for 1 year to receive: 1) Whole milk, 3 cups/d or 2) Nonfat milk, 3 cups/d. To promote adherence to the interventions, the investigators will rely on home delivery of milk using methods consistent with previous successful studies.
Study Outcomes The primary outcome is change in fat mass measured by air displacement plethysmography (BodPod) at 3 time points (baseline and 6 and 12 months). To evaluate cardiometabolic disease risk factors, the investigators will obtain a plasma MetaboProfile®(LabCorp) that includes lipoprotein particle sizes and subfraction concentrations, novel measures of insulin-resistant dyslipoproteinemia and inflammation, and a conventional lipid profile. The investigators will also measure blood pressure.
For the Ancillary Study, outcomes include salivary cariogenicity (pH, flow, and buffering capacity); caries prevalence; dietary quality (cariogenic potential); and serum 25-hydroxyvitamin D.
Вмешательства
- Поведенческое Whole milk
Weekly home delivery of whole milk, daily text messages, monthly virtual visits - Поведенческое Nonfat milk
Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits
Первичные конечные точки
- Fat mass [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
Вторичные конечные точки (12)
- Lean body mass [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Percent body fat [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Height [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Body mass index (BMI) [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Leptin [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Ghrelin [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Insulin-like growth factor-1 (IGF-1) [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Insulin-like growth factor-binding protein 3 (IGF-BP3) [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Lipoprotein insulin resistance (LPIR) [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Triglyceride-rich lipoprotein particle (TRL-P) size [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- High-density lipoprotein particle (HDL-P) size [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
- Low-density lipoprotein particle (LDL-P) size [Срок оценки: Change from start of trial (time of randomization) through end of trial (12 months)]
Критерии участия
Критерии включения
- Aged 9 to 12 years
- BMI ≥75th percentile for sex and age
- Residence in the Greater Boston catchment area
Критерии исключения
- Aversion to nonfat or whole milk
- Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided)
- Plans to move away from the Greater Boston catchment area during the study period
- Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation)
- Change in body weight exceeding 10% during prior year
- Recent adherence to a special diet
- Chronic use of any medication or dietary supplement that could affect study outcomes
- Another member of the family (first degree relative) or household participating in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- New Balance Foundation Obesity Prevention Center — Boston
Публикации
- Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605. PMID 18779274
- Ebbeling CB. Confusion at the milk cooler: opportunity to bolster the evidence base for preventive nutrition. Am J Clin Nutr. 2020 Feb 1;111(2):240-241. doi: 10.1093/ajcn/nqz319. No abstract available. PMID 31901161
- Willett WC, Ludwig DS. Milk and Health. N Engl J Med. 2020 Feb 13;382(7):644-654. doi: 10.1056/NEJMra1903547. No abstract available. PMID 32053300
Идентификаторы
NCT: NCT05464186 · IRB-P00041990