Overweight , ObesityDGA-UPNCT07252037
Dietary Guidelines for Americans-Ultra Processed Study
A study testing Low-processed DGA Diet and Ultra-processed DGA Diet in people with Overweight , Obesity and Class I Obesity, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this research is to test how processing food can affect how one's body responds to it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight , Obesity, Class I Obesity
- What is being tested?
- Low-processed DGA Diet and Ultra-processed DGA Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2029
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5-34.9 kg/m2
- Systolic <139 mm Hg and Diastolic <90 mm Hg
- Able to understand and sign the consent form
- Have own transportation to the Grand Forks Human Nutrition Research Center
- Not allergic to study foods or unwilling to eat them
- Willing to comply with study demands
- Able to read and understand English
Who cannot join
- Taking statins or medication to lower blood pressure,
- Taking anti-inflammatory or anti-diabetes medications
- Pregnant, lactating, or planning to become pregnant
- Diagnosed with an eating disorder
- Taking weight loss medications
- Smoke or use other tobacco products, including e-cigarettes
Show all 11Show fewer
- Have overt hypothyroidism
- Diagnosed with cancer
- Exercise more than 30 minutes per day 2 or more days per week
- Allergic to study foods
- Express unwillingness to consume study foods at the screening appointment
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Impact of Dietary Guidelines Diets Containing Mostly Ultra-Processed Foods Compared to Less-Processed Foods on Biomarkers of Cardiometabolic Disease
The purpose of this research is to test how processing food can affect how one's body responds to it.
Read the detailed description
The purpose of this project is to address the current gap in research on ultra-processed foods (UPFs) and cardiometabolic health with a feeding study that addresses the limitations of previously conducted intervention studies in matching UPF- and unprocessed- foods intervention diets for diet quality, nutrient content, and food type. Therefore, the primary objective is to evaluate diets composed primarily of ultra-processed or less processed foods that meet dietary guidelines recommendations on chronic disease risk factors. More specifically, when Dietary Guidelines for Americans (DGA)-compliant diets comprised of mostly ultra-processed and unprocessed foods (per Nova) are fed to generally healthy participants, determine whether there is an impact on:
- blood pressure
- fasting glucose and insulin concentrations, or
- lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides).
- Conditions
- Overweight , Obesity, Class I Obesity
- Being tested
- Low-processed DGA Diet, Ultra-processed DGA Diet
- Keywords
- Healthy Weight, Stage I Hypertension
- Medical subject headings
- Overweight, Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-processed DGA DietOther
Participants will consume a DGA menu made up of low-processed foods over a 4-week period
Ultra-processed DGA DietOther
Participants will consume a DGA menu primarily made up of ultra-processed foods over a 4-week period
| Study group | Role | What they receive |
|---|---|---|
| Low-processed DGA Diet | Experimental | Participants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised of low-processed foods (Nova Categories 1-3) Receives: Other: Low-processed DGA Diet |
| Ultra-processed DGA Diet | Experimental | Participants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised primarily of ultra-processed foods (Nova Category 4) Receives: Other: Ultra-processed DGA Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in systolic and diastolic blood pressure from baseline
Mean difference in systolic and diastolic blood pressure from baseline
Measured: Week 0, Week 4
Secondary outcomes (2)
Mean difference in fasting glucose and fasting insulin concentrations from baseline
Mean difference in fasting glucose and fasting insulin concentrations from baseline
Measured: Week 0, Week 4
Mean difference in fasting triglyceride concentrations from baseline
Mean difference in fasting triglyceride concentrations from baseline
Measured: Week 0, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: Change in administrative priorities. Protocol has been published, but recruitment never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie Hess, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252037
- Sponsor's protocol ID
- GFHNRC158
- Acronym
- DGA-UP
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Guidelines Diets Containing Mostly Ultra-Processed Foods Compared to Less-Processed Foods on Biomarkers of Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT07252037
- Acronym / sponsor ID
- DGA-UP / GFHNRC158
- Conditions
- Overweight , Obesity, Class I Obesity
- Keywords
- Healthy Weight, Stage I Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in administrative priorities. Protocol has been published, but recruitment never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test how processing food can affect how one's body responds to it.
Detailed description
The purpose of this project is to address the current gap in research on ultra-processed foods (UPFs) and cardiometabolic health with a feeding study that addresses the limitations of previously conducted intervention studies in matching UPF- and unprocessed- foods intervention diets for diet quality, nutrient content, and food type. Therefore, the primary objective is to evaluate diets composed primarily of ultra-processed or less processed foods that meet dietary guidelines recommendations on chronic disease risk factors. More specifically, when Dietary Guidelines for Americans (DGA)-compliant diets comprised of mostly ultra-processed and unprocessed foods (per Nova) are fed to generally healthy participants, determine whether there is an impact on:
- blood pressure
- fasting glucose and insulin concentrations, or
- lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-processed DGA Diet | Experimental | Other: Low-processed DGA DietParticipants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised of low-processed foods (Nova Categories 1-3) |
| Ultra-processed DGA Diet | Experimental | Other: Ultra-processed DGA DietParticipants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised primarily of ultra-processed foods (Nova Category 4) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI 18.5-34.9 kg/m2
- Systolic <139 mm Hg and Diastolic <90 mm Hg
- Able to understand and sign the consent form
- Have own transportation to the Grand Forks Human Nutrition Research Center
- Not allergic to study foods or unwilling to eat them
Key exclusion criteria (11 listed)
- Taking statins or medication to lower blood pressure,
- Taking anti-inflammatory or anti-diabetes medications
- Pregnant, lactating, or planning to become pregnant
- Diagnosed with an eating disorder
- Taking weight loss medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-processed DGA DietParticipants will consume a DGA menu made up of low-processed foods over a 4-week period | Other | Low-processed DGA Diet |
| Ultra-processed DGA DietParticipants will consume a DGA menu primarily made up of ultra-processed foods over a 4-week period | Other | Ultra-processed DGA Diet |
Primary outcome
Mean difference in systolic and diastolic blood pressure from baseline
Time frame: Week 0, Week 4
Mean difference in systolic and diastolic blood pressure from baseline
2 secondary outcomes
Mean difference in fasting glucose and fasting insulin concentrations from baseline
Time frame: Week 0, Week 4
Mean difference in fasting triglyceride concentrations from baseline
Time frame: Week 0, Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Hess, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-processed DGA Diet and Ultra-processed DGA Diet in people with Overweight , Obesity and Class I Obesity, run by USDA Grand Forks 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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 7 Aug 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean difference in systolic and diastolic blood pressure from baseline (time frame: Week 0, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.