Dietary Guidelines for Obesity

(DGA-UP Trial)

JH
Overseen ByJulie Hess, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: USDA Grand Forks Human Nutrition Research Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how the body's response to food changes when consuming low-processed versus ultra-processed foods, in accordance with the Dietary Guidelines for Americans. Participants will be divided into two groups: one will consume mostly low-processed foods, and the other will consume mostly ultra-processed foods. Individuals with a body mass index (BMI) between 18.5 and 34.9, who do not use tobacco or take medications like statins or blood pressure drugs, may be suitable candidates. As an unphased study, this trial provides a unique opportunity to contribute to understanding dietary impacts on health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes people who are taking statins, blood pressure medications, anti-inflammatory drugs, anti-diabetes medications, or weight loss medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the low-processed DGA Diet is generally easy to follow. Studies suggest that reducing processed foods can positively impact health, such as managing obesity and related conditions. This diet provides a good mix of vitamins and minerals.

Specific information on the safety of the ultra-processed DGA Diet is limited. However, diets high in ultra-processed foods are common and often linked to various health issues. Despite their popularity, these foods' long-term effects on health can be concerning due to more additives and lower nutritional quality.

Both diets are based on the Dietary Guidelines for Americans, which experts have reviewed, suggesting a basic level of safety for both options. Prospective trial participants should discuss any concerns with their healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these dietary interventions for obesity because they explore how the level of food processing impacts weight management. Unlike typical weight loss strategies that focus on calorie counting or macronutrient manipulation, these diets adhere to the Dietary Guidelines for Americans while varying the processing level of the foods consumed. The Low-processed DGA Diet emphasizes minimally processed foods, potentially offering benefits related to satiety and nutrient density. On the other hand, the Ultra-processed DGA Diet provides a unique opportunity to study the effects of highly processed foods on obesity, which is particularly relevant given the prevalence of such foods in modern diets. This trial could reveal important insights into how food processing affects body weight and health, informing future dietary recommendations.

What evidence suggests that this trial's diets could be effective for obesity?

This trial will compare the effects of two diets on obesity management: the Low-processed DGA Diet and the Ultra-processed DGA Diet. Research has shown that a diet with fewer processed foods, like the Low-processed DGA Diet, can aid in managing obesity. One study found that following the Dietary Guidelines for Americans with mostly unprocessed foods improved the Healthy Eating Index score by an average of 32.7 points, indicating better diet quality.

In contrast, the Ultra-processed DGA Diet, another arm of this trial, may not aid weight management. Studies have found a strong link between consuming many ultra-processed foods and weight gain or obesity, especially in adults. These foods are also associated with higher risks of heart disease and other health problems.

In summary, while diets with fewer processed foods seem promising for improving diet quality and managing obesity, diets high in ultra-processed foods might lead to weight gain and health issues.34567

Who Is on the Research Team?

JH

Julie Hess, PhD

Principal Investigator

USDA Grand Forks Human Nutrition Research Center

Are You a Good Fit for This Trial?

This trial is for individuals with a Body Mass Index (BMI) between 18.5 and 34.9, normal blood pressure readings (systolic <139 mm Hg and diastolic <90 mm Hg), who can understand and sign the consent form, have their own transport to the research center, are not allergic to study foods, willing to comply with study demands, and can read and understand English.

Inclusion Criteria

My BMI is between 18.5 and 34.9.
I can understand and sign the consent form.
I can drive myself to the Grand Forks Human Nutrition Research Center.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are provided with either a low-processed or ultra-processed Dietary Guidelines for Americans (DGA) compliant diet to evaluate the impact on cardiometabolic biomarkers

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Low-processed DGA Diet
  • Ultra-processed DGA Diet
Trial Overview The study is examining how different diets affect the body by comparing two types of diets: one that follows low-processed dietary guidelines for Americans (DGA) versus another that includes ultra-processed foods in accordance with DGA.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Ultra-processed DGA DietExperimental Treatment1 Intervention
Group II: Low-processed DGA DietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

USDA Grand Forks Human Nutrition Research Center

Lead Sponsor

Trials
60
Recruited
5,300+

Citations

Toward a science-based classification of processed foods ...A science-based classification of processed foods to support meaningful research and effective health policies.
A randomized controlled-feeding trial based on the Dietary ...The total HEI score, on average, relative to the intervention diet increased by 32.7 points in the DGA group and decreased by 6.5 points in the TAD group. No ...
Dietary Patterns and Growth-Risk of ObesityThis systematic review was conducted by the 2025 Dietary Guidelines Advisory Committee as part of the process to develop the. Dietary Guidelines for Americans, ...
Scientific Report of the 2025 Dietary Guidelines Advisory ...This first print of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee is being published by the Department of Health ...
Request for Public Comments on the Scientific Report ...As USDA researchers have shown, a diet “with 91 percent of the calories coming from ultra-processed foods (as classified using the NOVA scale),” ...
Expert consensus on nutrition and lower-carbohydrate dietsData indicate that a well-constructed low-carbohydrate dietary pattern could have positive impacts on decreasing the high prevalence of obesity, prediabetes, ...
Using Less Processed Food to Mimic a Standard American ...The LPW had similar nutrient density and diet quality scores to the MPW (HEI scores of 44 and 43, respectively). The LPW included 20% energy (kcal) from UPFs, ...
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