Purple Diet vs Ultra-processed Diet for Obesity
(ULTRA PIlot Trial)
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Assessments of study outcomes conducted at baseline prior to randomization
Dietary Intervention - UPF Diet
Participants follow the ultra-processed food diet for 14 days
Wash-out Period
Participants undergo a wash-out period between dietary conditions
Dietary Intervention - Purple Diet
Participants follow the Purple Diet for 14 days
Follow-up
Participants are monitored for changes in clinical and metabolic outcomes after dietary interventions
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
The ultra-processed (UPF) diet is designed to contain approximately 75% of energy from ultra-processed foods. Foods and ingredients in the ultra-processed diet consist of those defined in the NOVA classification as "ultra-processed" (group 4 of the classification). The NOVA classification groups foods according to the nature, extent and purpose of the industrial processing they undergo.10 In the NOVA classification, ultra-processed foods include such things as soft drinks, packaged snacks, reconstituted meat products and pre-prepared frozen dishes, and are made mostly or entirely from substances derived from foods and additives, with little if any unprocessed foods.
The Purple Diet is modeled after a typical American diet which is popular, widely available, and lower in cost compared to other diets. However, the diet is high in total fat, and particularly in saturated fat, with consumption far exceeding 10% of total energy intake. Intake of added sugars also far exceeds the recommended limits. The Purple Diet has been used in the Nutrition for Precision Health study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pennington Biomedical Research Center
Lead Sponsor
Citations
Long-Term Efficacy and Safety of Anti-Obesity Treatment - PMC
Recent RCTs demonstrated that licogliflozin, a dual SGLT1/2 inhibitor, significantly reduced body weight by 5.7% over 12 weeks and 3.8% over 24 weeks in obese ...
Anthocyanins from purple corn ameliorated obesity in high ...
APM administration (400 mg/kg) significantly decreased body weight gain, epididymal fat mass, total cholesterol and total triglyceride levels in HFD mice.
How the Purple Weight Loss Pill Influences Metabolism
Q2: How long does it take to see any effect? Most studies reporting measurable outcomes used an 8‑ to 12‑week intervention period. Early changes ...
Implementation and effectiveness of a care process to ...
The coprimary outcomes were average patient weight loss at 6 months and weight loss maintenance from 6 months to 18 months. In total, 274,182 ...
Effectiveness of Changing Dietary Fat on Weight Loss
Calorie controlled diets have routinely been demonstrated to help in both short and long-term weight reduction in individuals who are overweight or obese. In ...
The Impact of Produce Prescriptions on Diet, Food Security ...
Low F&V intake is an established risk factor for multiple poor health outcomes, including higher risk of coronary heart disease, stroke, adiposity, and cancer.
Preventing Obesity and Its Consequences
Summarizes key RAND studies on the causes of obesity, its economic and health consequences, and potential strategies for prevention, ...
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 ...
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