The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health

Официальное название

The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study

Обзор

This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.

Подробное описание

This is a 3-period randomized crossover complete feeding study examining if a dietary pattern containing cottonseed oil improves lipids/lipoproteins and other cardiometabolic disease risk factors to a greater extent than a fatty acid matched diet devoid of cottonseed oil and a diet lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA), but with a matched PUFA:SFA ratio

Вмешательства

• Другое Healthy Dietary Pattern with Cottonseed Oil
  Cottonseed Oil
• Другое Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils
  Plant oil blend fatty acid matched
• Другое Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil
  Plant oil with matched PUFA to SFA ratio

Первичные конечные точки

• LDL-cholesterol concentration [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

• Triglycerides concentration [Срок оценки: 4 weeks]
• Total Cholesterol concentration [Срок оценки: 4 weeks]
• HDL-cholesterol concentration [Срок оценки: 4 weeks]
• Particle Size and Number of LDL, HDL, VLDL and Chylomicrons [Срок оценки: 4 weeks]
• Central Systolic and Diastolic Blood Pressure [Срок оценки: 4 weeks]
• Brachial Systolic and Diastolic Blood Pressure [Срок оценки: 4 weeks]
• Carotid-Femoral Pulse Wave Velocity [Срок оценки: 4 weeks]
• Fasting Serum Insulin concentration [Срок оценки: 4 weeks]
• Fasting Plasma Glucose concentration [Срок оценки: 4 weeks]
• Fasting Serum Fructosamine concentration [Срок оценки: 4 weeks]
• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Срок оценки: 4 weeks]
• Dihydrosterculic acid [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• LDL-C ≥100 mg/dL and ≤190 mg/dL
• BMI of 25-40 kg/m2
• Blood pressure <140/90 mmHg
• Fasting blood glucose <126 mg/dL
• Fasting triglycerides <350 mg/dL
• ≤10% change in body weight for 6 months prior to enrollment

Критерии исключения

• Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
• Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
• Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
• Diagnosed liver, kidney, or autoimmune disease
• Prior cardiovascular event (e.g., stroke, heart attack)
• Current pregnancy or intention of pregnancy within the next 6 months
• Lactation within prior 6 months
• Follows a vegetarian or vegan diet
• Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
• Antibiotic use within the prior 1 month
• Oral steroid use within the prior 1 month
• Use of tobacco or nicotine containing products with in the past 6 months
• Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
• Participation in another clinical trial within 30 days of baseline
• Currently following a restricted or weight loss diet
• Prior bariatric surgery
• Intake of >14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The Pennylvania State University — University Park

Идентификаторы

NCT: NCT06216678 · POS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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