Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Change in body weight
研究概览
简要总结
This study, at the Western Human Nutrition Research Center (WHNRC), will focus on whether or not achieving and maintaining a healthy body weight is the most important health promoting recommendation of the Dietary Guidelines for Americans (DGA).The investigators hypothesize that improvement in cardiometabolic risk factors resulting from eating a DGA style diet will be greater in people whose energy intake is restricted to result in weight loss compared to those who maintain their weight. The investigators further propose that during a state of energy restriction, a higher nutrient quality diet such as the DGA style diet pattern, will result in greater improvement in cardiometabolic risk factors compared to a typical American diet (TAD) pattern that tends to be lower nutrient quality (more energy-dense and less nutrient-rich.)
详细描述
This will be a 28-week study including pre-diet testing (week 1), an 8-week controlled feeding period, post-diet testing (week 10), a follow-up period of dietary education and observation, and end of study testing (week 28). During the 8 week feeding, participants will be randomly assigned one of the following diets:
- DGA Mediterranean diet pattern at sufficient energy level to maintain body weight (energy balance)
- DGA Mediterranean diet pattern at a moderately reduced energy level (negative energy balance)
- TAD diet pattern at a moderately reduced energy level (negative energy balance)
In the follow-up phase, the investigators will evaluate how multiple factors may influence body weight management, including previous dietary exposure, as well as the role of cognitive function, executive function, genetics, habitual diet, physical activity, eating behavior, stress and stress responsivity, metabolic flexibility and gut microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) 23-39.9 kg/m2 or 32-50% body fat percentage
- •Willingness to have blood drawn
- •The criteria listed above and at least one of the following: Fasting glucose ≥100 mg/dL but <126 mg/dL or Fasting triglyceride ≥125 mg/dL or HDL-cholesterol ≤50 mg/dL or Blood Pressure (BP): Systolic BP ≥130 mmHg or Diastolic BP ≥85 mmHg or Hemoglobin A1C ≥ 5.7 and <6.5%
排除标准
- •Active participation in another research study
- •Tested positive for COVID-19 within the past 10 days
- •Been in close contact with a COVID-19 positive person within the past 14 days
- •Blood Pressure (BP): Systolic BP ≥140 mmHg or Diastolic BP ≥90 mmHg
- •LDL cholesterol ≥190 mg/dL
- •Triglycerides ≥500 mg/dL
- •Current use of smoking or chewing tobacco, e-cigarettes, cigars, vaping, cannabis or other use of nicotine containing products (within the past 6 months)
- •Current use of dietary supplements and/or unwillingness to cease intake of dietary supplements
- •Vegan or vegetarian lifestyle or any other dietary restrictions that would interfere with consuming the intervention foods and beverages (including dietary intolerances, allergies and sensitivities)
- •Unwillingness to consume intervention foods and beverages
- •Engage in more than moderate drinking (> 1 drink serving per day) or binge drinking (4 drinks within two hours).
- •Unwillingness to cease alcohol intake as required for specific duration of the study
- •Excessive intake of caffeine containing products (excessive defined as ≥ 400 mg/day)
- •Unwillingness to refrain from caffeine intake on lab visit days.
- •Intentional weight change of ≥5% of body weight within 6 months of entry into the study
- •Diagnosis of disordered eating or eating disorder
- •Recent diagnosis of any of the following or measurement on screening lab tests: Anemia (hemoglobin <11.7 g/dL) or abnormal liver or thyroid function (defined as liver enzymes that are >200% of upper limit (ALT upper limit is 43 U/L or Aspartate transaminase (AST) upper limit is 54 U/L) and thyroid function tests: Thyroxine (T4, free) <0.56 or >1.64 ng/dL; Thyroid-stimulating hormone (TSH) <0.35 or >5.6 μIU/mL).
- •History of any of the following: Gastric bypass surgery, inflammatory bowel disease (IBD) or other GI conditions that would interfere with consuming the intervention foods, active cancer in the past three years excluding squamous or basal cell carcinomas of the skin that have been handled medically by local excision and other serious medical conditions
- •Recent dental work or have conditions of the oral cavity that would interfere with consuming the intervention foods and beverages
- •Taking any medication in the class of antipsychotics
- •Long term use of antibiotics
- •Taking any over the counter or prescribed medication for any of the following: Elevated lipids, elevated glucose, high blood pressure, weight loss or conditions that require corticosteroids (e.g. asthma, arthritis or eczema).
- •Are pregnant, planning to become pregnant within the duration of the study or breastfeeding.
研究组 & 干预措施
DGA Mediterranean diet pattern, energy balance
Diet plan focused on energy balance (meets calorie needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.
干预措施: DGA Mediterranean diet pattern, energy balance (Other)
TAD diet pattern
Typical American Diet (TAD) with negative energy balance (~25% calorie reduction compared to needs) which mimics intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium based on data from What We Eat in America (WWEIA).
干预措施: TAD diet pattern, negative energy balance (Other)
DGA Mediterranean diet pattern, negative energy balance
Negative energy balance (~25% calorie reduction compared to needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.
干预措施: DGA Mediterranean diet pattern, negative energy balance (Other)
结局指标
主要结局
Change in body weight
时间窗: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.
次要结局
- Change in waist circumference(Week 1, 10, 28)
- Change in hip circumference(Week 1, 10, 28)
- Change in body mass index(Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28)
- Change in body fat (via DEXA scan)(Week 1, 10, 28)
- Change in resting systolic blood pressure(Week 1, 10, 28)
- Change in liver fat(Week 1 and 10)
- Change in body water (via InBody)(Week 1, 10, 28)
- Change in waist to hip ratio(Week 1, 10, 28)
- Change in resting diastolic blood pressure(Week 1, 10, 28)
- Change in liver stiffness(Week 1 and 10)
- Height(Week 1)
- Change in resting heart rate(Week 1, 10, 28)
- Genetic Risk of Obesity(Week 1)
- Change in hemoglobin A1C(Week 1, 10, 28)
- Change in urinary potassium(Week 1, 5, 7 and 10)
- Change in C-reactive protein(Week 1, 10, 28)
- Change in total cholesterol(Week 1 and 10)
- Change in vascular health(Week 1, 5, 10)
- Change in red blood cell fatty acids(Week 1, 10, 28)
- Change in high density lipoprotein (HDL) cholesterol(Week 1 and 10)
- Change in triglycerides in response to a meal(Baseline and 1, 2, 3, and 6 hours after a challenge meal)
- Change in blood metabolite profiles(Week 1 and 10)
- Change in fasting blood glucose(Week 1, 10, 28)
- Change in urinary sodium(Week 1, 5, 7 and 10)
- Change in urinary nitrogen(Week 1, 5, 7 and 10)
- Change in carotenoid levels(Week 1 and 10)
- Change in allostatic load(Week 1, 10, 28)
- Change in low density lipoprotein (LDL) cholesterol(Week 1 and 10)
- Change in perceived stress(Week 1, 6, 10, 19 and 28)
- Barriers to physical activity(Week 1)
- Usual physical activity(Week 1)
- Diet acceptability(Week 10)
- Change in heart rate variability(Week 1 and 10)
- Change in ghrelin in response to a meal(Baseline and 1, 2, 3, and 6 hours after a challenge meal)
- Change in leptin in response to a meal(Baseline and 1, 2, 3, and 6 hours after a challenge meal)
- Change in Matsuda Index(Baseline and 1, 2 hours after a challenge meal)
- Change in executive function(Week 1 and 10)
- Change in verbal memory(Week 1 and 10)
- Change in spatial memory(Week 1 and 10)
- Change in multitasking(Week 1 and 10)
- Change in social cognition(Week 1 and 10)
- Change in attentive function(Week 1 and 10)
- Change in insulin in response to a meal(Baseline and 1, 2, 3, and 6 hours after a challenge meal)
- Change in resting metabolic rate(Week 1 and 10)
- Change in post-prandial metabolic rate(1, 2, 3 and 6 hours after a meal)
- Change in metabolic flexibility(Week 1 and 10)
- Change in predicted VO2 max(Week 1, 10, 28)
- Change in interstitial glucose levels(Week 1 and 10)
- Change in response speed(Week 1 and 10)
- Change in psycho-motor speed(Week 1 and 10)
- Change in continuous systolic blood pressure(Week 1 and 10)
- Change in continuous diastolic blood pressure(Week 1 and 10)
- Change in mood(Week 1 and 10)
- Change in diet satisfaction(Week 1, 19 and 28)
- Change in Food Choice(Week 1 and 10)
- Change in oxygen consumption rate (OCR)(Week 1 and 10)
- Change in mean arterial blood pressure(Week 1 and 10)
- Change in self-efficacy(Week 10, 19 and 28)
- Change in appetite(Week 1 and 10)
- Three factor eating questionnaire(Week 1 and 10)
- Yale Food Addiction Scale(Week 1)
- Changes in dietary intake(Week 1, 19, and 28)
- Change in stress reactivity(Week 1 and 10)
- Change in extracellular acidification rate (ECAR)(Week 1 and 10)
- Change in fecal microbiome(Week 1, 10 an 28)