Purple Diet vs Ultra-processed Diet for Obesity

(ULTRA PIlot Trial)

PT
Overseen ByPeter T Katzmarzyk, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Pennington Biomedical 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 tests two types of diets—the Purple Diet and an ultra-processed diet—to assess their effects on obesity-related health outcomes. The study aims to determine the feasibility of enrolling and following participants while collecting data for a larger future trial. Participants will alternate between the two diets over two weeks, allowing researchers to evaluate the health impacts of each diet. Ideal candidates are individuals who have been dealing with being overweight or obese and are willing to adhere to the assigned diet plans. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on diet and obesity.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that affect weight or diabetes outcomes, you must have been on a stable dose for at least 3 months to participate.

What prior data suggests that these dietary interventions are safe?

Previous studies on the Purple Diet, which includes foods rich in purple pigments, have shown potential benefits for weight management and health. Research suggests that purple foods might help lower cholesterol and control weight gain. For example, in a study where neither participants nor researchers knew who received the purple food product, participants reported feeling slightly less hungry after consuming it. This suggests the diet is generally well-tolerated and may positively affect weight.

Conversely, studies on the Ultra-processed Diet have raised health concerns. Consuming large amounts of ultra-processed foods is linked to higher risks of obesity and related health issues. People who frequently eat these foods are more likely to gain weight and develop problems like heart disease and diabetes. This indicates that while the diet is safe, excessive consumption over time may lead to negative health effects.12345

Why are researchers excited about this trial?

Researchers are excited about these dietary approaches for obesity because they explore the impact of food processing levels on weight management. The Ultra-processed Diet examines foods that make up a significant part of many people's diets, such as soft drinks and packaged snacks, which are often linked to weight gain. On the other hand, the Purple Diet, despite being high in saturated fat and sugars, provides a comparison to typical American eating habits, which can offer insights into realistic dietary modifications. Unlike traditional weight loss treatments focusing on medications or surgical interventions, this trial could reshape how we understand dietary influences on obesity by highlighting the effects of food processing.

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

This trial will compare the effects of a Purple Diet with an Ultra-processed Diet on obesity. Studies have shown that consuming large amounts of ultra-processed foods (UPF) is linked to weight gain and a higher risk of obesity. One study found that people gained about 2 pounds on a UPF diet, while they lost weight on a diet with less processed foods. In contrast, purple foods, which contain natural pigments called anthocyanins, may aid in weight loss and improve cholesterol levels in people with obesity. Animal studies suggest these pigments can reduce body fat and cholesterol. While both diets are being tested in this trial, current evidence indicates that ultra-processed foods may cause weight gain, whereas purple foods might assist with weight loss.12678

Who Is on the Research Team?

PT

Peter T Katzmarzyk, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adults with overweight or obesity (BMI between 25 and 50) who can speak English, are willing to follow assigned diets and provide health data. Women must be premenopausal. Participants need to give informed consent.

Inclusion Criteria

My BMI is between 25 and 50.
I am a woman who has not yet reached menopause.
I can speak and write in English.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Assessments of study outcomes conducted at baseline prior to randomization

1 week

Dietary Intervention - UPF Diet

Participants follow the ultra-processed food diet for 14 days

2 weeks
2-3 visits per week for meal pick-up

Wash-out Period

Participants undergo a wash-out period between dietary conditions

2 weeks

Dietary Intervention - Purple Diet

Participants follow the Purple Diet for 14 days

2 weeks
2-3 visits per week for meal pick-up

Follow-up

Participants are monitored for changes in clinical and metabolic outcomes after dietary interventions

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Purple Diet
  • Ultra-processed diet

Trial Overview

The study compares two diets: a 'purple diet' (typical American diet) and a diet high in ultra-processed foods. Each participant tries both diets for two weeks in random order to see how each affects health markers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ultra-processed DietExperimental Treatment1 Intervention
Group II: Purple DietActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials
314
Recruited
183,000+

Citations

Long-Term Efficacy and Safety of Anti-Obesity Treatment - PMC

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Obesity

A body mass index (BMI) over 25 is considered overweight, and over 30 is obese. In 2019, an estimated 5 million noncommunicable disease (NCD) deaths were caused ...