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Impact of diets with different degrees of processing and energy density on health

Metabolic effects of diets free or rich in ultra-processed foods and with high or low energy density in healthy adults: randomized crossover clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10gfr3fb
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Energy Intake

Interventions

A randomized, controlled, non-blinded, crossover clinical trial, with four research arms. Due to the crossover design, all individuals will undergo the four diets at different times, in a randomized s
b) ultra-processed foods+/energy density- group: ultra-processed foods-rich diet [=80% kcal] and low energy density [=1.2 kcal/g]
c) ultra-processed foods-/energy density+ group: ultra-processed foods-free diet [0% kcal] and high energy density (=2.0 kcal/g)
d) ultra-processed foods-/energy density- group: ultra-processed foods-free diet [0% kcal] and low energy density [= 1.2 kcal/g]. The sequence of diets will be randomly defined using the SAMPLE functi

Sponsors

Faculdade de Nutrição - Universidade Federal de Alagoas
Lead Sponsor
Faculdade de Nutrição - Universidade Federal de Alagoas
Collaborator

Eligibility

Age
19 Years to 30 Years

Inclusion criteria

Inclusion criteria: Age between 19 and 30 years; both sexes; body mass index between 18.5 and 24.9 kg/m²; body mass index between 18.5 and 30 kg/m²; bioimpedance fat percentage <30% for men and <42% for women; stable weight for at least 1 month; willing to follow the schedule proposed by the research

Exclusion criteria

Exclusion criteria: Chronic use of any medication (eg. : anti-diabetics, anti-hypertensives, anti-depressants, anti-retrovirals, immunosuppressants); altered fasting blood glucose, blood pressure or lipid profile; condition that makes it impossible to perform anthropometry, measurement of energy expenditure components, or blood collection; individuals who are unable to consume the diet provided and/or have any food intolerances/allergies/restrictions; disordered eating behavior assessed using the Three-Factor Eating Questionnaire-18 tool; smokers; pregnant and breastfeeding women

Design outcomes

Primary

MeasureTime frame
Assess ad libitum energy intake (kilocalories) at a standard dinner. This meal will be offered at the end of each intervention day and, on a separate day, under normal eating conditions (control dinner), with an average energy density of 1.7 kilocalories per gram and 20% of energy coming from ultra-processed foods

Secondary

MeasureTime frame
Assess the concentration of the appetite hormones ghrelin, leptin, adiponectin, and insulin. Measurements will be taken at three times: after a 12-hour fast, 4 hours after breakfast, and 4 hours after lunch;To assess eating rate during the interventions. Measurements of grams consumed per minute, milliliters consumed per minute, calories consumed per minute, bites per minute, and chews per gram/kilocalorie will be performed using a camera to monitor real-time intake during all meals;Assess hunger, fullness, satisfaction, and capacity to eat. These will be measured using visual analog scales before and after meals (30, 60, 90, 120, 180, and 240 minutes) in each intervention. In addition, familiarity and pleasantness will be assessed 30 minutes after meals;Metabolomic profiles will be analyzed by hydrogen-1 nuclear magnetic resonance in serum. Samples, collected after fasting for 12 hours, 4 hours after breakfast, and 4 hours after lunch, will be prepared with deuterated buffer (D2O)

Countries

Brazil

Contacts

Public ContactNassib Bueno

Faculdade de Nutrição - Universidade Federal de Alagoas

nassib.bueno@fanut.ufal.br+55 (82) 99976-6895

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 6, 2026