Processed vs Unprocessed Diet for Obesity

Overseen By Valerie L Darcey

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Must not be taking: Diet medications, others

Disqualifiers: Diabetes, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Protocol Number: 22DK0002 Title: Effects of Ultra-processed versus Unprocessed Diets on Energy Metabolism Background: Many diets worldwide include both processed and unprocessed foods. Researchers want to study the effects these foods have on a person s health. Objective: To study how different diets affect a person s health and metabolism. Eligibility: Adults aged 18 60 without diabetes who have stable weight and can exercise. Design: Participants will be screened with: Medical history Physical exam Heart tests Resting energy expenditure (to determine calorie needs) Blood and urine tests 20-minute stationary bicycle session Food, diet, and mental health questionnaires Participants will stay at NIH for 4 weeks. They will receive 3 meals a day and may eat as little or as much as they want. The diet will change each week. Their weight will be recorded daily. They will ride a stationary bicycle daily. Each week, they will do the following: Spend 1 day in a special room that assesses their metabolism Have 24-hour urine collections Give skin and fecal samples Repeat some screening tests Have scans to measure body fat Complete computerized behavior tasks Wear an activity monitor to track physical activity Wear a glucose monitor. A sensor will be inserted under the skin with a small needle. It will be replaced weekly. Take taste tests. They will swish water and flavored liquids around in their mouth and pick which ones had a non-neutral taste. They will also compare liquids for which ones taste better. Participation will last for 4 weeks. Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases ...

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications or drugs that may influence appetite, as these are part of the exclusion criteria for the study.

Is it safe to consume ultra-processed foods?

Research suggests that consuming ultra-processed foods may be linked to higher risks of chronic diseases like cancer, heart disease, type-2 diabetes, and obesity. Some food additives in these products have shown possible adverse effects in early studies, and public health authorities recommend limiting their consumption. ^{1 2 3 4 5}

How does the treatment of processed vs unprocessed diet for obesity differ from other treatments?

This treatment is unique because it focuses on the type of food consumed, specifically comparing ultra-processed foods, which are industrially made and often high in added sugars and unhealthy additives, to unprocessed foods, which are linked to higher diet quality. Unlike traditional obesity treatments that might focus on calorie restriction or medication, this approach examines the impact of food processing on health. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment Ultra-processed food for obesity?

Research indicates that high consumption of ultra-processed foods is linked to an increased risk of obesity and related health issues. Studies show that as the intake of these foods rises, so does the likelihood of being overweight or having abdominal obesity. ^{1 4 5 8 9}

Who Is on the Research Team?

Valerie L Darcey

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Are You a Good Fit for This Trial?

Adults aged 18-60 without diabetes, stable weight, and able to exercise can join this study. They must be willing to follow the study's lifestyle guidelines for 4 weeks at NIH, including daily cycling and various health tests. Those with appetite-affecting conditions or on certain medications cannot participate.

Inclusion Criteria

Body mass index (BMI) > =20 kg/m2

Provision of signed and dated informed consent form

My weight has been stable, with less than a 5% change in the past 6 months.

Exclusion Criteria

I have a condition like cancer, diabetes, or changes in smell/taste after COVID-19 that affects my appetite.

My hematocrit level is below 40%.

I am not on medications that affect my appetite, including weight-loss drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants will stay at NIH for 4 weeks, receiving different diets each week to study their effects on health and metabolism

4 weeks

Daily monitoring and activities

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultra-processed food, both high
• Ultra-processed food, both low
• Ultra-processed food, high energy density
• Unprocessed food diet

Trial Overview The trial is testing how different diets (ultra-processed vs unprocessed foods) impact energy metabolism over a period of four weeks. Participants will eat provided meals in controlled amounts and undergo regular health assessments to measure the effects.

How Is the Trial Designed?

Group I: 4/ UNF LL, UPF HH, UPF LL, UPF HL Experimental Treatment 4 Interventions

Four diets in the order specified

Group II: 3/ UPF LL, UNF LL, UPF HL, UPF HH Experimental Treatment 4 Interventions

Four diets in the order specified

Group III: 2/ UPF HL, UPF LL, UPF HH, UNF LL Experimental Treatment 4 Interventions

Four diets in the order specified

Group IV: 1/UPF HH, UPF HL, UNF LL, UPF LL Experimental Treatment 4 Interventions

Four diets in the order specified

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

From 1988 to 2018, a significant portion of the US food supply consisted of ultraprocessed foods (58%-65%), hyper-palatable foods (55%-69%), and high energy density foods (37%-47%), indicating a trend towards more processed and calorie-dense options.

The study found that while the overall availability of these food categories increased, hyper-palatable foods saw the largest rise (14%), suggesting a growing concern for obesity risk associated with these types of foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultraprocessed, hyper-palatable, and high energy density foods: Prevalence and distinction across 30 years in the United States. Sutton, CA., Stratton, M., L'Insalata, AM., et al.[2023]

Higher intake of unprocessed and minimally processed foods (UMP) is linked to improved diet quality metrics over 3 decades in two large cohorts of health professionals, with significant increases in scores for healthy eating indices.

In contrast, higher consumption of ultraprocessed foods (UPF) is associated with lower diet quality, indicating that UMP consumption promotes healthier eating patterns while UPF consumption detracts from them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intakes of Unprocessed and Minimally Processed and Ultraprocessed Food Are Associated with Diet Quality in Female and Male Health Professionals in the United States: A Prospective Analysis. Rossato, SL., Khandpur, N., Lo, CH., et al.[2023]

This systematic review and meta-analysis of 12 observational studies found that higher consumption of ultra-processed foods (UPF) is significantly associated with an increased risk of obesity (odds ratio of 1.55) and overweight (odds ratio of 1.36) in the general population.

Every 10% increase in UPF consumption in daily calorie intake correlates with a 7% higher risk of overweight, a 6% higher risk of obesity, and a 5% higher risk of abdominal obesity, indicating a clear link between UPF intake and excess weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis. Moradi, S., Entezari, MH., Mohammadi, H., et al.[2022]

High consumption of ultra-processed foods (UPF) is linked to a significant increase in the risk of overweight/obesity (39%), high waist circumference (39%), and metabolic syndrome (79%) based on a systematic review of 23 studies.

In a large cohort of 183,491 participants followed for 3.5 to 19 years, high UPF consumption was associated with a 25% increased risk of all-cause mortality and a 29% increased risk of cardiovascular disease, indicating serious long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. Pagliai, G., Dinu, M., Madarena, MP., et al.[2023]

The rise in consumption of ultra-processed foods (UPF) is linked to a growing prevalence of obesity and non-communicable diseases worldwide, indicating potential health risks associated with these products.

This correlation suggests that the increasing volume of industrially processed foods in the global food supply may negatively impact human health, warranting further investigation into dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods, Diet Quality and Human Health. Dinu, M., Martini, D.[2023]

Ultra-processed foods, which are heavily modified and often contain additives, have been linked to lower nutritional quality and increased risks of chronic diseases such as cancer, cardiovascular disease, and obesity, based on numerous global studies.

Public health authorities are now recommending a reduction in the consumption of ultra-processed foods, but more research is needed to understand the mechanisms behind their health impacts and to inform regulations on food additives and processing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultra-processed food : from research to guidelines]. Srour, B., Chazelas, E., Touvier, M.[2022]

Research identified 25 policy actions related to ultraprocessed foods in the U.S. from 1983 to 2022, with a focus on children's nutrition and food pricing, indicating a growing awareness of the issue.

Only one policy specifically defined ultraprocessed food, highlighting a gap in clear regulatory frameworks compared to other countries that have integrated ultraprocessed food considerations into their dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Policies Addressing Ultraprocessed Foods, 1980-2022. Pomeranz, JL., Mande, JR., Mozaffarian, D.[2023]

Ultra-processed foods make up 57.9% of energy intake in the USA and contribute a staggering 89.7% of the total energy intake from added sugars, indicating a strong link between these foods and high sugar consumption.

Individuals consuming the highest amounts of ultra-processed foods are significantly more likely to exceed the recommended limit of 10% of total energy from added sugars, with 82.1% in the highest consumption group surpassing this limit compared to only 26.4% in the lowest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed foods and added sugars in the US diet: evidence from a nationally representative cross-sectional study. Martínez Steele, E., Baraldi, LG., Louzada, ML., et al.[2022]

The semi-quantitative food frequency questionnaire (SFFQ) demonstrated acceptable validity in estimating energy intake from both unprocessed/minimally processed foods and ultra-processed foods among 226 Mexican adults, regardless of age group.

Correlation coefficients indicated a stronger relationship for ultra-processed foods (0.67 for adults <60 years and 0.48 for adults ≥60 years) compared to unprocessed/minimally processed foods, suggesting that the SFFQ is particularly effective for assessing intake of ultra-processed foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Semi-quantitative Food Frequency Questionnaire Has Relative Validity to Identify Groups of NOVA Food Classification System Among Mexican Adults. Oviedo-Solís, CI., Monterrubio-Flores, EA., Rodríguez-Ramírez, S., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Ultraprocessed, hyper-palatable, and high energy density foods: Prevalence and distinction across 30 years in the United States. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intakes of Unprocessed and Minimally Processed and Ultraprocessed Food Are Associated with Diet Quality in Female and Male Health Professionals in the United States: A Prospective Analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods, Diet Quality and Human Health. [2023]

6. France pubmed.ncbi.nlm.nih.gov

[Ultra-processed food : from research to guidelines]. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

U.S. Policies Addressing Ultraprocessed Foods, 1980-2022. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Ultra-processed foods and added sugars in the US diet: evidence from a nationally representative cross-sectional study. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Semi-quantitative Food Frequency Questionnaire Has Relative Validity to Identify Groups of NOVA Food Classification System Among Mexican Adults. [2022]