Ultra-Processed Foods and Appetite Regulation: Acute Effects Across Body Mass Index Categories

NCT06798220 | Completed

• 2 other identifiers: B.30.2.ODM.0.20.08/6635085
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to observe the acute effects of minimally processed and ultra-processed food (UPF) consumption on appetite in participants with normal body mass index (BMI) \[BMI: 18.5-24.99 kg/m2\] and overweight-obese (BMI \> 25 kg/m2) according to the NOVA (not an abbreviation) classification and to compare the postprandial effects of minimally processed and UPF consumption on appetite in normal and overweight-obese individuals. The study was designed as a non-randomized controlled, crossover study. The main questions it aims to answer are:

• Does a breakfast consisting of UPF affect appetite regulation differently compared to a breakfast consisting of unprocessed or minimally processed foods?
• Do the effects of foods with different levels of processing on appetite regulation vary by BMI? Researchers will evaluate the effects of a breakfast containing unprocessed or minimally processed foods and a breakfast containing ultra-processed foods, which are similar in terms of energy and macronutrients, on appetite regulation. Participants will:
• 1st experiment day: come to the laboratory where the experiment will be conducted at 8:00 am on an empty stomach and consume a breakfast containing unprocessed or minimally processed foods (chicken egg (boiled), white cheese (full-fat), black and green olive, tomato, cucumber, white bread, orange juice (freshly squeezed).
• 2nd experiment (after 2 weeks wash-out from 1st experiment): come to the laboratory where the experiment will be conducted at 8:00 am on an empty stomach and consume a breakfast containing ultra-processed food (packaged sandwich bread, beef sausage (pan-fried without oil), tomato ketchup, packaged orange juice).

Conditions

Healthy Adult Volunteers

Keywords

ultra-processed foods; obesity; appetite regulation; incretins

Outcome Measures

Primary Outcomes (2)

• Changes in appetite-related hormones

  Evaluate the levels of fasting and postprandial changes by taking samples at regular intervals for two hours (at the start of both breakfasts and subsequently at the 30th, 60th, 90th, and 120th minutes) in appetite regulatory hormones such as insulin, ghrelin, glucagon-like peptid-1, gastric inhibitory peptide, and amylin (nM) through commercially available enzyme-linked immunosorbent assay (ELISA) kits.

  At both the traditional breakfast and ultra-processed breakfast, blood samples were collected at the start of the both breakfasts and subsequently at the 30th, 60th, 90th, and 120th minutes.

• Changes in visual analogue scale score

  A visual analog scale (VAS) was used to subjectively assess postprandial appetite regulation. The VAS form, completed at each time point, comprises four questions: \[1\] "How hungry do you feel?" \[2\] "How full do you feel?" \[3\] "How strong is your desire to eat?" and \[4\] "How much do you think you could eat?". Participants were instructed to indicate their response by marking the appropriate point along a 100-mm line, which was intentionally left unnumbered to avoid influencing their answers. The participants' responses to the questions were quantified by measuring the marked point on the 100-mm line using a ruler.

  At both the traditional breakfast and ultra-processed breakfast, visual analogue scale was filled at the start of the both breakfasts and subsequently at the 30th, 60th, 90th, and 120th minutes.

Secondary Outcomes (1)

• Changes in the energy received during the rest of the experimental day

  After every two breakfasts for the rest of the day, one day for every two experimental days

Study Arms (2)

Trad-breakfast

EXPERIMENTAL

Participants were served a traditional breakfast on the first experimental day.

Other: Traditional Breakfast

UPF-breakfast

EXPERIMENTAL

Participants were served a ultra-processed breakfast on the second experimental day.

Other: UPF Breakfast

Interventions

Traditional Breakfast OTHER

In this intervention, participants are offered a traditional breakfast (consisting of unprocessed or minimally processed foods), and postprandial appetite regulation is evaluated. Traditional breakfast includes chicken egg (boiled), white cheese (full-fat), white bread, black and green olives, tomatoes, cucumbers, and freshly squeezed orange juice.

Trad-breakfast

UPF Breakfast OTHER

In this intervention, participants are offered an ultra-processed breakfast, and postprandial appetite regulation is evaluated. Ultra-processed breakfast includes pan-fried beef sausage (without oil), packaged sandwich bread, tomato-based ketchup, and packaged orange juice.

UPF-breakfast

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index between 18.50-24.99 kg/m2 or \> 25.00 kg/m2
• Not in premenstrual (1 week before menstruation) period or menstrual period for women participants

You may not qualify if:

• Being pregnant, breastfeeding, or postmenopausal
• Being in the premenstrual or menstruation phase
• Undergoing hormone replacement therapy
• Having an acute or chronic illness
• Taking regular medication (such as hormone replacement therapy, anticoagulants, antidepressants, antidiabetics, antihypertensives, antihyperlipidemics, proton pump inhibitors, etc.)
• Having a genetic and/or systemic disease
• Having any food allergies or intolerances
• Following a specific dietary regimen
• Smoking
• Consuming alcohol
• Having used antibiotics in the last 3 months
• Using prebiotics or probiotics
• Not giving consent after reading the informed consent form

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Kurupelit Campus, 55139 Atakum / SAMSUN

Samsun, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: May 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: January 15, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

TU (1)