Comparison of Dairy and Plant-based Alternatives in Adolescents and Older Adults

Обзор

The purpose of the Dairy vs Plant study is to compare the effects of dairy and plant-based alternative products on blood sugar regulation and nutrient quality in adolescents and older adults. We are inviting healthy, non-diabetic participants aged 14-18 and 60-75, both males and females to participate. The study will take place in the Nutrition Intervention Center located at the Department of Nutritional Sciences, University of Toronto St. George campus. Participants will be asked to come to the Nutrition Intervention Center on 3 separate occasions: once for an in-person screening lasting approximately 30min and 2 times for study visits lasting approximately 2.5 hrs each. The entire study will take a minimum of 2 weeks to complete. You will be asked to fast for 12hrs (overnight) prior to each study visit. You will also be instructed to maintain the same dietary and sleep patterns, refrain from exercise and alcohol consumption the days before the study visits. During these study visits, you will be asked to consume either a dairy or a plant-based alternative product, as well as a pizza meal. You will periodically fill out questionnaires rating your feelings and perceptions and provide blood samples through finger pricks and intravenously through forearm to measure blood sugar, insulin, hormones, and amino acids. You will be compensated for your time and travel expenses.

Вмешательства

• Другое Dairy
  The dairy products that participants will be required to consume include: 1) Trial 1: 2% cow's milk; 2) Trial 2: dairy yogurt; 3) Trial 3: 2% cottage cheese; 4) Trial 4: 2% cow's milk; and 5) Trial 5: isolated whey protein beverage. Participants will only be enrolled in 1 of the 5 trials; as such, they will only consume the 1 dairy product in that trial.
• Другое Plant-based alternative
  The plant-based products that participants will be required to consume include: 1) Trial 1: soy beverage; 2) Trial 2: plant-based yogurt; 3) Trial 3: tofu; 4) Trial 4: 2% simulated milk; and 5) Trial 5: isolated soy protein beverage. Participants will only be enrolled in 1 of the 5 trials; as such, they will only consume the 1 plant-based alternative product in that trial.

Первичные конечные точки

• Blood glucose [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]

Вторичные конечные точки (10)

• Insulin [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Glucagon-like Peptide-1 (GLP-1) [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Glucagon-like Peptide-2 (GLP-2) [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Gastric Inhibitory Polypeptide (GIP) [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Leptin [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Peptide YY (PYY) [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Cholecystokinin (CCK) [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Ghrelin [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Adiponectin [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]
• Amino Acids [Срок оценки: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.]

Критерии участия

Критерии включения

• Age 14-18 years old (adolescents) or 60-75 years old (older adults)
• BMI z-score >+1SD, <+2SD (adolescents) or BMI 25-30 kg/m2 (older adults)
• Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study.
• Willing to maintain current dietary supplement use throughout the study. On study visit days, subject agrees not to take any supplements until dismissal from the Nutrition Intervention Center.
• Willing to abstain from alcohol consumption for 24hrs prior to all study visits.
• Willing to avoid vigorous physical activity for 24hrs prior to all study visits.
• Willing to refrain from cannabis use throughout the entire duration of the study.
• Willing to refrain from protein supplement use (e.g. protein powder) throughout the entire duration of the study.
• Understands the study procedures, provides informed consent to participate in the study, and authorizes release of relevant protected health information to the study investigator.

Критерии исключения

• Smoking
• Thyroid problems
• Lactose intolerance and/or allergies, intolerances, or sensitivities to study treatments
• Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
• Presence of gastrointestinal disorder or surgeries within the past year.
• Inability to comply with the experimental procedures and follow our safety guidelines
• Regular breakfast skipping (>3 days a week)
• On a special diet (e.g. ketogenic, Atkins, high protein) or restrained eaters as identified by a score of >20 on the Eating Attitudes Questionnaire
• Difficulties with eating or swallowing
• Fasting blood glucose >5.6mmol/L measured at screening
• Uncontrolled hypertension (systolic blood pressure >120mmHg, diastolic blood pressure >80mmHg) as defined by the average blood pressure measured at screening
• Weight gain or loss of >10lbs in previous three months
• Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect outcome of the study as per investigator's judgement

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• Nutrition Intervention Center — Toronto

Публикации

• Da Silva N, Anderson G, Amr A, Vien S, Fabek H. A comparison of the effects of dairy products with their plant-based alternatives on metabolic responses in healthy young Canadian adults: a randomized crossover study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-17. doi: 10.1139/apnm-2024-0158. PMID 39146559

Идентификаторы

NCT: NCT06874400 · 47896 · 72072239

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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