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ObesityDGA4MENCT04293224

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

A study testing DGA Mediterranean diet pattern, energy balance, DGA Mediterranean diet pattern, negative energy balance and TAD diet pattern, negative energy balance in people with Obesity and Body Weight, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 19 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Body Weight
What is being tested?
DGA Mediterranean diet pattern, energy balance, DGA Mediterranean diet pattern, negative energy balance and TAD diet pattern, negative energy balance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
1 Aug 2022to 30 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 64 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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%

Who cannot join

  • 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
Show all 23Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC Davis, Western Human Nutrition Research Center

    Davis, California, 95616

Other trials in United States

About this study

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.)

Read the 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.

Conditions
Obesity, Body Weight
Being tested
DGA Mediterranean diet pattern, energy balance, DGA Mediterranean diet pattern, negative energy balance, TAD diet pattern, negative energy balance
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
Medical subject headings
Obesity, Body Weight, Prediabetic State, Metabolic Syndrome, Cardiovascular Diseases, Feeding Behavior, Glucose Intolerance, Prehypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DGA Mediterranean diet pattern, energy balanceOther

    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 balanceOther

    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 balanceOther

    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.

Study groups in NCT04293224
Study groupRoleWhat they receive
DGA Mediterranean diet pattern, energy balanceExperimentalDiet 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.
Receives: Other: DGA Mediterranean diet pattern, energy balance
DGA Mediterranean diet pattern, negative energy balanceExperimentalNegative 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.
Receives: Other: DGA Mediterranean diet pattern, negative energy balance
TAD diet patternExperimentalTypical 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).
Receives: Other: TAD diet pattern, negative energy balance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

    Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.

    Measured: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

Secondary outcomes (65)

  1. Height

    Height will be measured to the nearest 0.1 cm using a wall-mounted stadiometer.

    Measured: Week 1

  2. Change in body mass index

    Body weight and height will be used to calculate Body Mass Index (BMI) as kg/m2.

    Measured: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

  3. Change in body water (via InBody)

    Measured using bioelectrical impedance analysis (BIA) with an InBody 770® expressed as kg.

    Measured: Week 1, 10, 28

  4. Change in body fat (via DEXA scan)

    Fat mass (grams) will be measured using dual energy x-ray absorptiometry (DEXA).

    Measured: Week 1, 10, 28

  5. 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.

    Measured: Week 1, 10, 28

  6. 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.

    Measured: Week 1, 10, 28

  7. Change in waist to hip ratio

    Waist and hip circumference will be expressed as a ratio.

    Measured: Week 1, 10, 28

  8. 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.

    Measured: Week 1, 10, 28

  9. 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.

    Measured: Week 1, 10, 28

  10. Change in resting heart rate

    Resting heart rate (pulse) will obtained via automated instrument in beats per minute.

    Measured: Week 1, 10, 28

  11. 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).

    Measured: Week 1

  12. 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.

    Measured: Week 1, 5, 10

  13. Change in liver fat

    Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®

    Measured: Week 1 and 10

  14. Change in liver stiffness

    Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®

    Measured: Week 1 and 10

  15. 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.

    Measured: Week 1 and 10

  16. Change in fasting blood glucose

    This outcome will evaluate blood sugars levels in the fasted state.

    Measured: Week 1, 10, 28

  17. 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.

    Measured: Week 1, 10, 28

  18. 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.

    Measured: Week 1, 5, 7 and 10

  19. 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.

    Measured: Week 1, 5, 7 and 10

  20. 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.

    Measured: Week 1, 5, 7 and 10

  21. Change in red blood cell fatty acids

    Red blood cell fatty acids will be analyzed by mass spectrometry (MS).

    Measured: Week 1, 10, 28

  22. Change in C-reactive protein

    C-Reactive Protein will be measured as a non-specific marker for inflammation.

    Measured: Week 1, 10, 28

  23. 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.

    Measured: Week 1 and 10

  24. Change in total cholesterol

    Total cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).

    Measured: Week 1 and 10

  25. Change in high density lipoprotein (HDL) cholesterol

    HDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).

    Measured: Week 1 and 10

  26. Change in low density lipoprotein (LDL) cholesterol

    LDL cholesterol will be collected to evaluate cardiac risk expressed as milligrams per deciliter (mg/dL).

    Measured: Week 1 and 10

  27. Change in triglycerides in response to a meal

    Triglycerides will be measured in blood (mg/dL).

    Measured: Baseline and 1, 2, 3, and 6 hours after a challenge meal

  28. Change in ghrelin in response to a meal

    Ghrelin will be evaluated as an indicator of hunger signaling.

    Measured: Baseline and 1, 2, 3, and 6 hours after a challenge meal

  29. Change in leptin in response to a meal

    Leptin will be evaluated as an indicator of satiety signaling.

    Measured: Baseline and 1, 2, 3, and 6 hours after a challenge meal

  30. 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).

    Measured: Baseline and 1, 2, 3, and 6 hours after a challenge meal

  31. Change in Matsuda Index

    Matsuda index will be calculated from plasma glucose and insulin.

    Measured: Baseline and 1, 2 hours after a challenge meal

  32. 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.

    Measured: Week 1 and 10

  33. Change in post-prandial metabolic rate

    Post-prandial metabolic rate measured using indirect calorimetry.

    Measured: 1, 2, 3 and 6 hours after a meal

  34. 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.

    Measured: Week 1 and 10

  35. 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.

    Measured: Week 1, 10, 28

  36. 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.

    Measured: Week 1 and 10

  37. Change in executive function

    Assessed using Cambridge Gambling Task (CGT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  38. Change in response speed

    Assessed using Motor Screening Task (MOT), from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  39. Change in verbal memory

    Assessed using Verbal Recognition Memory (VRM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  40. Change in psycho-motor speed

    Assessed using Reaction Time (RTI) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  41. Change in spatial memory

    Assessed using Spatial Working Memory (SWM) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  42. Change in multitasking

    Assessed using Multitasking Test (MTT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  43. Change in social cognition

    Assessed using Emotional Recognition (ERT) task from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  44. Change in attentive function

    Assessed using Stop Signal Task (STT) from Cambridge Neuropsychological Test Automated Battery (CANTAB).

    Measured: Week 1 and 10

  45. 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.

    Measured: Week 1, 10, 28

  46. Change in continuous systolic blood pressure

    Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.

    Measured: Week 1 and 10

  47. Change in continuous diastolic blood pressure

    Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg.

    Measured: Week 1 and 10

  48. Change in mean arterial blood pressure

    Blood pressure measured using a Continuous Non-invasive Arterial Pressure (CNAP®) device in mmHg .

    Measured: Week 1 and 10

  49. 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.

    Measured: Week 1 and 10

  50. 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.

    Measured: Week 1, 6, 10, 19 and 28

  51. 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.

    Measured: Week 10, 19 and 28

  52. 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.

    Measured: Week 1, 19 and 28

  53. 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.

    Measured: Week 1 and 10

  54. 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.

    Measured: Week 1 and 10

  55. Barriers to physical activity

    Participants will be asked to complete the Barriers to Being Active questionnaire.

    Measured: Week 1

  56. 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.

    Measured: Week 1

  57. 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.

    Measured: Week 10

  58. 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).

    Measured: Week 1

  59. 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.

    Measured: Week 1, 19, and 28

  60. Change in stress reactivity

    Acute stress reactivity will be assessed by measuring salivary cortisol concentrations in response to a challenging task.

    Measured: Week 1 and 10

  61. 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.

    Measured: Week 1 and 10

  62. 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.

    Measured: Week 1 and 10

  63. 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.

    Measured: Week 1 and 10

  64. 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.

    Measured: Week 1 and 10

  65. Change in fecal microbiome

    Assays will be performed on fecal samples to determine DNA representing the colonic microbiota.

    Measured: Week 1, 10 an 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start1 Aug 2022
  3. Primary completion30 Jul 2026
  4. Study completion30 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04293224
Sponsor's protocol ID
FL111
Acronym
DGA4ME
Status last verified
Sep 2026
First submitted
27 Feb 2020
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized metabolomics data will be deposited on Metabolomics Work Bench (https://www.metabolomicsworkbench.org/), a national and international repository for metabolomics data and metadata, developed in support of the National Institutes of Health (NIH) Common Fund Metabolomics Program and housed at the San Diego Supercomputer Center (SDSC), University of California, San Diego. Archived data will include raw data files, quality assurance data, final analytical data, and associated experimental metadata including experimental group assignments, anthropometric, physiological and clinical measures.

Publications

  • 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.

    PubMed 30101333

Questions about this trial

What is this clinical trial studying?

A study testing DGA Mediterranean diet pattern, energy balance, DGA Mediterranean diet pattern, negative energy balance and TAD diet pattern, negative energy balance in people with Obesity and Body Weight, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04293224, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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