Clinical trial NCT04293224: Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
Official title: Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Body Weight
Keywords: Dietary Guidelines for Americans
Physical Activity for Americans
Mediterranean Diet
Controlled Feeding
Women
PreDiabetes
Metabolic Syndrome
Cognitive Function
Stress, Physiological
Executive Function
Cardiovascular Diseases
Cardiovascular Risk Factor
Eating Behavior
Glucose Intolerance
Metabolomic Profiling
Metabolic flexibility
Gut Microbiome
Genome Testing
Prehypertension
Insulin Resistance
Insulin Sensitivity
Hypertriglyceridemic
Waist to Hip Ratio
Allostatic Load
Physiology
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2020-03-03
Enrollment: 123
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.)

Detailed description: 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:

1. DGA Mediterranean diet pattern at sufficient energy level to maintain body weight (energy balance)
2. DGA Mediterranean diet pattern at a moderately reduced energy level (negative energy balance)
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in body weight
timeFrame: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Secondary outcomes:
measure: Height
timeFrame: Week 1
measure: Change in body mass index
timeFrame: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
measure: Change in body water (via InBody)
timeFrame: Week 1, 10, 28
measure: Change in body fat (via DEXA scan)
timeFrame: Week 1, 10, 28
measure: Change in waist circumference
timeFrame: Week 1, 10, 28
measure: Change in hip circumference
timeFrame: Week 1, 10, 28
measure: Change in waist to hip ratio
timeFrame: Week 1, 10, 28
measure: Change in resting systolic blood pressure
timeFrame: Week 1, 10, 28
measure: Change in resting diastolic blood pressure
timeFrame: Week 1, 10, 28
measure: Change in resting heart rate
timeFrame: Week 1, 10, 28
measure: Genetic Risk of Obesity
timeFrame: Week 1
measure: Change in vascular health
timeFrame: Week 1, 5, 10
measure: Change in liver fat
timeFrame: Week 1 and 10
measure: Change in liver stiffness
timeFrame: Week 1 and 10
measure: Change in blood metabolite profiles
timeFrame: Week 1 and 10
measure: Change in fasting blood glucose
timeFrame: Week 1, 10, 28
measure: Change in hemoglobin A1C
timeFrame: Week 1, 10, 28
measure: Change in urinary sodium
timeFrame: Week 1, 5, 7 and 10
measure: Change in urinary potassium
timeFrame: Week 1, 5, 7 and 10
measure: Change in urinary nitrogen
timeFrame: Week 1, 5, 7 and 10
measure: Change in red blood cell fatty acids
timeFrame: Week 1, 10, 28
measure: Change in C-reactive protein
timeFrame: Week 1, 10, 28
measure: Change in carotenoid levels
timeFrame: Week 1 and 10
measure: Change in total cholesterol
timeFrame: Week 1 and 10
measure: Change in high density lipoprotein (HDL) cholesterol
timeFrame: Week 1 and 10
measure: Change in low density lipoprotein (LDL) cholesterol
timeFrame: Week 1 and 10
measure: Change in triglycerides in response to a meal
timeFrame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
measure: Change in ghrelin in response to a meal
timeFrame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
measure: Change in leptin in response to a meal
timeFrame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
measure: Change in insulin in response to a meal
timeFrame: Baseline and 1, 2, 3, and 6 hours after a challenge meal
measure: Change in Matsuda Index
timeFrame: Baseline and 1, 2 hours after a challenge meal
measure: Change in resting metabolic rate
timeFrame: Week 1 and 10
measure: Change in post-prandial metabolic rate
timeFrame: 1, 2, 3 and 6 hours after a meal
measure: Change in metabolic flexibility
timeFrame: Week 1 and 10
measure: Change in predicted VO2 max
timeFrame: Week 1, 10, 28
measure: Change in interstitial glucose levels
timeFrame: Week 1 and 10
measure: Change in executive function
timeFrame: Week 1 and 10
measure: Change in response speed
timeFrame: Week 1 and 10
measure: Change in verbal memory
timeFrame: Week 1 and 10
measure: Change in psycho-motor speed
timeFrame: Week 1 and 10
measure: Change in spatial memory
timeFrame: Week 1 and 10
measure: Change in multitasking
timeFrame: Week 1 and 10
measure: Change in social cognition
timeFrame: Week 1 and 10
measure: Change in attentive function
timeFrame: Week 1 and 10
measure: Change in allostatic load
timeFrame: Week 1, 10, 28
measure: Change in continuous systolic blood pressure
timeFrame: Week 1 and 10
measure: Change in continuous diastolic blood pressure
timeFrame: Week 1 and 10
measure: Change in mean arterial blood pressure
timeFrame: Week 1 and 10
measure: Change in mood
timeFrame: Week 1 and 10
measure: Change in perceived stress
timeFrame: Week 1, 6, 10, 19 and 28
measure: Change in self-efficacy
timeFrame: Week 10, 19 and 28
measure: Change in diet satisfaction
timeFrame: Week 1, 19 and 28
measure: Change in appetite
timeFrame: Week 1 and 10
measure: Three factor eating questionnaire
timeFrame: Week 1 and 10
measure: Barriers to physical activity
timeFrame: Week 1
measure: Usual physical activity
timeFrame: Week 1
measure: Diet acceptability
timeFrame: Week 10
measure: Yale Food Addiction Scale
timeFrame: Week 1
measure: Changes in dietary intake
timeFrame: Week 1, 19, and 28
measure: Change in stress reactivity
timeFrame: Week 1 and 10
measure: Change in heart rate variability
timeFrame: Week 1 and 10
measure: Change in Food Choice
timeFrame: Week 1 and 10
measure: Change in oxygen consumption rate (OCR)
timeFrame: Week 1 and 10
measure: Change in extracellular acidification rate (ECAR)
timeFrame: Week 1 and 10
measure: Change in fecal microbiome
timeFrame: Week 1, 10 an 28
Other outcomes:
Locations:
city: Davis
country: United States
facility: UC Davis, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, Western Human Nutrition Research Center
name: Kevin D Laugero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krishnan S, Adams SH, Allen LH, Laugero KD, Newman JW, Stephensen CB, Burnett DJ, Witbracht M, Welch LC, Que ES, Keim NL. A randomized controlled-feeding trial based on the Dietary Guidelines for Americans on cardiometabolic health indexes. Am J Clin Nutr. 2018 Aug 1;108(2):266-278. doi: 10.1093/ajcn/nqy113.