Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans

Obesity Clinical Trial

— DGA4ME  

Official title:

Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293224
• Other study ID #: FL111
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: USDA, Western Human Nutrition Research Center
• Contact: Beverly Miller, BS, RDN
• Phone: 530-754-2541
• Email: bevmiller[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Other:
• DGA Mediterranean diet pattern, energy balance
Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations.
• DGA Mediterranean diet pattern, negative energy balance
Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations
• TAD diet pattern, negative energy balance
Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the be based on evidence collected from What We Eat in America (WWEIA) data. Based on this data the participants will be provided a diet that reflects American dietary trends.

Locations

Country	Name	City	State
United States	UC Davis, Western Human Nutrition Research Center	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.	Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Secondary	Height	Height will be measured to the nearest 0.1 cm using a wall-mounted stadiometer.	Week 1
Secondary	Change in body mass index	Body weight and height will be used to calculate Body Mass Index (BMI) as kg/m2.	Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Secondary	Change in body water (via InBody)	Measured using bioelectrical impedance analysis (BIA) with an InBody 770® expressed as kg.	Week 1, 10, 28
Secondary	Change in body fat (via DEXA scan)	Fat mass (grams) will be measured using dual energy x-ray absorptiometry (DEXA).	Week 1, 10, 28
Secondary	Change in waist circumference	Waist circumference is measured with an anthropometric tape. Measurements will be performed in duplicate and averages recorded to the nearest 0.1 cm.	Week 1, 10, 28
Secondary	Change in hip circumference	Hip circumference is measured with an anthropometric tape. Measurements will be performed in duplicate and averages recorded to the nearest 0.1 cm.	Week 1, 10, 28
Secondary	Change in waist to hip ratio	Waist and hip circumference will be expressed as a ratio.	Week 1, 10, 28
Secondary	Change in resting systolic blood pressure	Blood pressure will obtained via automated instrument and blood pressure cuff. At least two measurements will be made, expressed in mmHg, and the average value will be recorded.	Week 1, 10, 28
Secondary	Change in resting diastolic blood pressure	Blood pressure will obtained via automated instrument and blood pressure cuff. At least two measurements will be made, expressed in mmHg, and the average value will be recorded.	Week 1, 10, 28
Secondary	Change in resting heart rate	Resting heart rate (pulse) will obtained via automated instrument in beats per minute.	Week 1, 10, 28
Secondary	Genetic Risk of Obesity	Genomic DNA will be collected from white blood cells. A polygenic risk score (PRS) indexing genetic predisposition to obesity using known obesity single nucleotide polymorphisms (SNPs).	Week 1
Secondary	Change in vascular health	Peripheral Arterial Tone (PAT) technology will be used to measure vascular health. The EndoPAT test is a non-invasive measurement of the overall health of the endothelium.	Week 1, 5, 10
Secondary	Change in liver fat	Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®	Week 1 and 10
Secondary	Change in liver stiffness	Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®	Week 1 and 10
Secondary	Change in blood metabolite profiles	Analysis of metabolites, the small molecule substrates, intermediates and products of metabolism analyzed by mass spectrometry (MS). Includes branched chain amino acids, 2 hydroxybutyric acid, acylcarnitines, saturated, monounsaturated and polyunsaturated non-esterified fatty acids, triglyceride species, phospholipid species, bile acids and steroid hormones.	Week 1 and 10
Secondary	Change in fasting blood glucose	This outcome will evaluate blood sugars levels in the fasted state.	Week 1, 10, 28
Secondary	Change in hemoglobin A1C	This outcome will evaluate glycated hemoglobin as a reflection of the plasma glucose level during the past two to three months.	Week 1, 10, 28
Secondary	Change in urinary sodium	Urinary sodium will be measured as indicators of dietary compliance during the feeding intervention of the study. All urine passed for a 24 hour period will be collected.	Week 1, 5, 7 and 10
Secondary	Change in urinary potassium	Urinary potassium will be measured as indicators of dietary compliance during the feeding intervention of the study. All urine passed for a 24 hour period will be collected.	Week 1, 5, 7 and 10
Secondary	Change in urinary nitrogen	Urinary nitrogen will be measured as indicators of dietary compliance during the feeding intervention of the study. All urine passed for a 24 hour period will be collected.	Week 1, 5, 7 and 10
Secondary	Change in red blood cell fatty acids	Red blood cell fatty acids will be analyzed by mass spectrometry (MS).	Week 1, 10, 28
Secondary	Change in C-reactive protein	C-Reactive Protein will be measured as a non-specific marker for inflammation.	Week 1, 10, 28
Secondary	Change in carotenoid levels	Serum carotenoids, including vitamin A, alpha-carotene, and beta-carotene will be used to evaluate nutrient status and dietary intake of vegetables prior to feeding intervention and post feeding intervention.	Week 1 and 10
Secondary	Change in total cholesterol	Total cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).	Week 1 and 10
Secondary	Change in high density lipoprotein (HDL) cholesterol	HDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).	Week 1 and 10
Secondary	Change in low density lipoprotein (LDL) cholesterol	LDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).	Week 1 and 10
Secondary	Change in triglycerides in response to a meal	Triglycerides will be measured in blood (mg/dL).	Baseline and 1, 2, 3, and 6 hours after a challenge meal
Secondary	Change in ghrelin in response to a meal	Ghrelin will be evaluated as an indicator of hunger signaling.	Baseline and 1, 2, 3, and 6 hours after a challenge meal
Secondary	Change in leptin in response to a meal	Leptin will be evaluated as an indicator of satiety signaling.	Baseline and 1, 2, 3, and 6 hours after a challenge meal
Secondary	Change in insulin in response to a meal	Insulin measured in blood using an antibody based assay. Will also be expressed as the quantitative insulin sensitivity check index (QUICKI).	Baseline and 1, 2, 3, and 6 hours after a challenge meal
Secondary	Change in Matsuda Index	Matsuda index will be calculated from plasma glucose and insulin.	Baseline and 1, 2 hours after a challenge meal
Secondary	Change in resting metabolic rate	Respiratory gas exchange measurements (oxygen consumption-VO2 and carbon dioxide production-VCO2) will be made to determine metabolic rate using a metabolic cart system.	Week 1 and 10
Secondary	Change in post-prandial metabolic rate	Post-prandial metabolic rate measured using indirect calorimetry.	1, 2, 3 and 6 hours after a meal
Secondary	Change in metabolic flexibility	The formula is designed to deliver approximately 800 kcals total with 60% kcals from fat (approximately 55 g of fat), 25% kcals from carbohydrates, and 15% of kcals from protein.	Week 1 and 10
Secondary	Change in predicted VO2 max	Cardiorespiratory endurance will be evaluated by measuring heart rate (HR) and oxygen consumption (VO2) during a walking graded exercise test on a treadmill.	Week 1, 10, 28
Secondary	Change in interstitial glucose levels	A continuous glucose monitor (CGM) will be used to continuously assess interstitial glucose levels. The Abbott Freestyle Libre Pro Sensor is inserted under the skin on the back of the arm. The sensor will measure the interstitial glucose level every fifteen minutes. Participants will wear the monitors for fourteen days.	Week 1 and 10
Secondary	Change in executive function	Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in response speed	Assessed using Motor Screening Task (MOT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in verbal memory	Assessed using Verbal Recognition Memory (VRM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in psycho-motor speed	Assessed using Reaction Time (RTI) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in spatial memory	Assessed using Spatial Working Memory (SWM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in multitasking	Assessed using Multitasking Test (MTT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in social cognition	Assessed using Emotional Recognition (ERT) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in attentive function	Assessed using Stop Signal Task (STT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).	Week 1 and 10
Secondary	Change in allostatic load	Allostatic load (AL) is an aggregate value derived from several parameters that assess physiologic adaptive response to neural or neuroendocrine stressors. The following measures are used to determine the AL score: Urinary cortisol and catecholamine levels, resting blood pressure, waist to hip ratio, blood levels of high sensitivity C-Reactive Protein, cholesterol, dehydroepiandrosterone sulfate and hemoglobin A1c, and urinary levels of epinephrine and norepinephrine.	Week 1, 10, 28
Secondary	Change in continuous systolic blood pressure	Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.	Week 1 and 10
Secondary	Change in continuous diastolic blood pressure	Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.	Week 1 and 10
Secondary	Change in mean arterial blood pressure	Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg .	Week 1 and 10
Secondary	Change in mood	Mood assessed using the Profile of Mood States (POMS). Total Mood Disturbance (TMD) score is found from the difference between "negative" subscales - "positive" subscales. Individual scores on the POMS range from -32 to 200 with higher scores indicating higher mood disturbance.	Week 1 and 10
Secondary	Change in perceived stress	Perceived stress measured using the Perceived stress scale (PSS). Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Responses for individual questions are summed to a total score.	Week 1, 6, 10, 19 and 28
Secondary	Change in self-efficacy	This 20 item questionnaire is a measurement of the capacity to execute behaviors necessary to change their weight and begin to implement exercise in their lives regularly.	Week 10, 19 and 28
Secondary	Change in diet satisfaction	This 28 item questionnaire acts as a valid instrument for assessing diet satisfaction in the context of weight-management. This measurement assesses diet satisfaction both within and outside the context of weight-loss treatment, as well as to assesses change in satisfaction as a result of treatment.	Week 1, 19 and 28
Secondary	Change in appetite	A computer tablet with stylus will be used to assess hunger and appetite, defined as perceived hunger, fullness, desire to eat, prospective consumption and other measures of food craving and perceived hypoglycemia. Questions will be presented one-by-one on the screen and participants will be asked to express their response using visual analog scales (VAS). This measurement will be evaluated during the meal challenge assessment.	Week 1 and 10
Secondary	Three factor eating questionnaire	This 18 item questionnaire is used to examine three dimensions of human eating behavior including cognitive restraint, disinhibition or uncontrolled eating and hunger.	Week 1 and 10
Secondary	Barriers to physical activity	Participants will be asked to complete the Barriers to Being Active questionnaire.	Week 1
Secondary	Usual physical activity	An accelerometer (Actical) will be continuously worn by participants during waking hours (excluding bathing and swimming) for a period of 7 days.The measure of usual physical activity is used to estimate total energy expenditure and energy requirements.	Week 1
Secondary	Diet acceptability	This measurement is an evaluation of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed controlled feeding diet.	Week 10
Secondary	Yale Food Addiction Scale	Measures markers of substance dependence with the consumption of high fat/high sugar foods. This is a 25-item self-report measure that includes mixed response categories (dichotomous and Likert-type format).	Week 1
Secondary	Changes in dietary intake	Three non-consecutive twenty-four hour dietary recalls will be collected when subjects are self-selecting their 'usual' diets. A three day average nutrient intake will be expressed.	Week 1, 19, and 28
Secondary	Change in stress reactivity	Acute stress reactivity will be assessed by measuring salivary cortisol concentrations in response to a challenging task.	Week 1 and 10
Secondary	Change in heart rate variability	Autonomic physiological functioning will be assessed using the MindWare Cardio/Galvanic Skin Response (GSR) system, a device that connects to the subject's torso with eight disposable electrodes and a heart rate monitor. Emotional arousal via skin conductance, a form of electrodermal activity (EDA) is also measured.	Week 1 and 10
Secondary	Change in Food Choice	Food choice computer-based tests from Leeds, United Kingdom, will be used to estimate explicit liking and implicit wanting for several different categories of foods.	Week 1 and 10
Secondary	Change in oxygen consumption rate (OCR)	Measured in peripheral blood mononuclear cells by use of Seahorse XF Analyzer, a tool for measuring glycolysis and oxidative phosphorylation (through oxygen consumption) simultaneously in the same cells.	Week 1 and 10
Secondary	Change in extracellular acidification rate (ECAR)	Measured in peripheral blood mononuclear cells by use of Seahorse XF Analyzer, a tool for measuring glycolysis and oxidative phosphorylation (through oxygen consumption) simultaneously in the same cells.	Week 1 and 10
Secondary	Change in fecal microbiome	Assays will be performed on fecal samples to determine DNA representing the colonic microbiota.	Week 1, 10 an 28

External Links

•   WHNRC website