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Postprandial MetabolismTHERMOS-LUNCHNCT07808736

Postprandial Metabolic Responses to Sustainable and Non-Sustainable Meals in Healthy Young Men

A study testing Healthy-Sustainable Test Meal and Non-Sustainable Test Meal in people with Postprandial Metabolism and Healthy Volunteers, run by University of Parma at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized crossover study evaluated the acute postprandial metabolic and hydration responses to two standardized lunch meals differing in nutritional quality and environmental footprint in healthy young men. Each participant consumed both meals in separate experimental visits according to a randomized sequence. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Postprandial Metabolism, Healthy Volunteers
What is being tested?
Healthy-Sustainable Test Meal and Non-Sustainable Test Meal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteItaly
Study dates
1 Nov 2025to 24 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male participants aged 18 to 30 years.
  • Students enrolled at the University of Parma.
  • Residence or domicile in areas surrounding the University of Parma campus.
  • Stable body weight during the previous 6 months, defined as body weight change within ±5%.
  • Good general health.
  • Willingness to comply with study procedures.
  • Written informed consent provided before participation.

Who cannot join

  • Female sex.
  • Age younger than 18 years or older than 30 years.
  • Smoking.
  • Food allergies or food intolerances incompatible with the test meals.
  • Chronic noncommunicable food-related diseases, including metabolic, endocrine, or chronic disorders.
  • Residence or domicile outside areas adjacent to the University of Parma campus.
  • Students enrolled at the University of Parma in Gastronomic Sciences or Human Nutrition Sciences.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University of Parma, Department of Food and Drug

    Parma, Parma, 43125

Other trials in Italy

About this study

Official title: THERMOS-LUNCH: Effects of Meals Differing in Nutritional Quality and Environmental Footprint on Postprandial Metabolism, Diet-Induced Thermogenesis, Respiratory Quotient, Satiety, and Hydration Status in Healthy Young Men

This randomized crossover study evaluated the acute postprandial metabolic and hydration responses to two standardized lunch meals differing in nutritional quality and environmental footprint in healthy young men. Each participant consumed both meals in separate experimental visits according to a randomized sequence. Postprandial oxygen consumption, carbon dioxide production, respiratory quotient, energy expenditure, diet-induced thermogenesis, substrate oxidation, satiety, and hydration-related outcomes were assessed.

Read the detailed description

The THERMOS-LUNCH study (Thermogenesis, Hydration, Environmental Impact, Respiratory Quotient, Meals, Substrate Oxidation and Sustainability after Lunch in University Students: a Nutritional Crossover Study in Healthy Subjects) was a randomised, two-period, two-sequence crossover intervention study conducted in healthy male university students. The study compared two standardised lunch meals that differed in nutritional quality and estimated environmental impact: a healthy and sustainable meal and a less healthy and non-sustainable comparison meal. Participants were randomly assigned to one of two intervention sequences: the healthy and sustainable meal followed by the comparison meal, or the comparison meal followed by the healthy and sustainable meal. The two experimental visits were separated by a 7-day washout period.

During each experimental visit, postprandial metabolic responses were assessed using portable indirect calorimetry. Oxygen consumption, carbon dioxide production, respiratory exchange ratio, energy expenditure, diet-induced thermogenesis and substrate oxidation were measured during the fasting baseline period and over the 4-hour postprandial period. Subjective appetite and satiety sensations were assessed repeatedly using 100-millimetre visual analogue scales. Hydration-related measures included total fluid intake, urine volume, urine colour and urine specific gravity measured using a digital refractometer. Total urinary nitrogen, obtained from the 24-hour urine collection, was used to account for protein metabolism in substrate-oxidation calculations, while urinary creatinine was used as a quality-control marker for the plausibility and completeness of the 24-hour urine collection.

Being tested
Healthy-Sustainable Test Meal, Non-Sustainable Test Meal
Keywords
Diet-Induced Thermogenesis, Respiratory Quotient, Indirect Calorimetry, Substrate Oxidation, Sustainable Diet, Hydration Status, Satiety, Healthy Young Men

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy-Sustainable Test MealOther

    Standardized lunch meal characterized by a healthier nutritional profile and lower environmental footprint. The meal was designed to have lower carbon and water footprints compared with the non-sustainable test meal. The healthy-sustainable meal had an estimated carbon footprint of 620 g CO₂-eq and water footprint of 956.6 L, whereas the non-sustainable meal had an estimated carbon footprint of 1104 g CO₂-eq and water footprint of 1605.1 L.

  • Non-Sustainable Test MealOther

    Standardized lunch meal characterized by a less favorable nutritional profile and higher environmental footprint compared with the healthy-sustainable test meal. The healthy-sustainable meal had an estimated carbon footprint of 620 g CO₂-eq and water footprint of 956.6 L, whereas the non-sustainable meal had an estimated carbon footprint of 1104 g CO₂-eq and water footprint of 1605.1 L.

Study groups in NCT07808736
Study groupRoleWhat they receive
Healthy-Sustainable Then Non-Sustainable MealExperimentalParticipants assigned to this sequence consumed the healthy-sustainable test meal during the first experimental visit and the non-sustainable test meal during the second experimental visit after a 7-day washout period.
Receives: Other: Healthy-Sustainable Test Meal; Other: Non-Sustainable Test Meal
Non-Sustainable Then Healthy-Sustainable MealExperimentalParticipants assigned to this sequence consumed the non-sustainable test meal during the first experimental visit and the healthy-sustainable test meal during the second experimental visit after a 7-day washout period.
Receives: Other: Healthy-Sustainable Test Meal; Other: Non-Sustainable Test Meal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diet-Induced Thermogenesis

    Diet-induced thermogenesis will be calculated from postprandial energy expenditure measured by portable indirect calorimetry after consumption of each test meal.

    Measured: Baseline and 0-240 minutes after test meal consumption during each experimental visit

  2. Respiratory Quotient

    Respiratory quotient will be calculated from oxygen consumption and carbon dioxide production measured by portable indirect calorimetry at fasting baseline and during the postprandial period.

    Measured: Baseline and 0-240 minutes after test meal consumption during each experimental visit

Secondary outcomes (15)
  1. Repeated Hunger Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    Description: Hunger was assessed using a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "I am not hungry at all", to 100 millimetres, anchored by "I have never been so hungry". Higher scores indicate greater hunger and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  2. Repeated Satiety Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    Satiety was assessed using the question "How satisfied do you feel?" on a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "I feel completely empty", to 100 millimetres, anchored by "I cannot eat even a single bite". Higher scores indicate greater satiety and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  3. Repeated Fullness Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    Fullness was assessed using a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "Not at all full", to 100 millimetres, anchored by "Completely full". Higher scores indicate greater fullness and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  4. Repeated Prospective Food Consumption Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    spective food consumption was assessed using the question "How much do you think you could eat?" on a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "Nothing", to 100 millimetres, anchored by "A lot". Higher scores indicate greater prospective food consumption and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  5. Repeated Desire for Sweet Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    Desire for sweet food was assessed using the question "Would you like to eat something sweet?" on a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "None", to 100 millimetres, anchored by "A lot". Higher scores indicate a greater desire to eat sweet food and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  6. Repeated Desire for Salty Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    Desire for salty food was assessed using the question "Would you like to eat something salty?" on a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "Yes, very much", to 100 millimetres, anchored by "No, not at all". Higher scores indicate a lower desire to eat salty food and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  7. Repeated Desire for Savoury Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    Desire for savoury food was assessed using the question "Would you like to eat something savoury?" on a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "Yes, very much", to 100 millimetres, anchored by "No, not at all". Higher scores indicate a lower desire to eat savoury food and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  8. Repeated Desire for Fatty Food Scores Assessed Using a 100-Millimetre Visual Analogue Scale

    Desire for fatty food was assessed using the question "Would you like to eat something fatty?" on a 100-millimetre visual analogue scale ranging from 0 millimetres, anchored by "Yes, very much", to 100 millimetres, anchored by "No, not at all". Higher scores indicate a lower desire to eat fatty food and do not necessarily represent a better or worse outcome. Scores were recorded repeatedly at the scheduled assessment time points during each experimental visit and are reported in millimetres.

    Measured: From the fasting assessment before the standardised breakfast to 240 minutes after consumption of the test lunch, during each experimental visit.

  9. Total Fluid Intake

    Total fluid intake was calculated as the sum of all measured fluids consumed during each experimental condition. One total value was calculated for each participant under each experimental condition and is expressed in millilitres.

    Measured: Over the 24-hour study period associated with each experimental condition.

  10. Total 24-Hour Urine Volume

    All urine produced during each 24-hour collection period was collected, and the total urine volume was measured. One total value was calculated for each participant under each experimental condition and is expressed in millilitres per 24 hours

    Measured: Over the 24-hour urine-collection period associated with each experimental condition.

  11. Morning Spot Urine Specific Gravity

    Urine specific gravity was measured in the morning spot urine sample using a digital refractometer. Triplicate measurements were averaged to obtain one value for each participant at each experimental visit. Urine specific gravity is dimensionless, and higher values indicate more concentrated urine.

    Measured: At the fasting morning urine collection before breakfast during each experimental visit.

  12. Urine Specific Gravity of the Pooled 24-Hour Urine Collection

    Urine specific gravity was measured in the pooled 24-hour urine sample using a digital refractometer. Triplicate measurements were averaged to obtain one value for each participant under each experimental condition. Urine specific gravity is dimensionless, and higher values indicate more concentrated urine.

    Measured: At completion of the 24-hour urine-collection period associated with each experimental condition.

  13. Urine Colour Score Assessed Using the Armstrong 8-Point Urine Colour Chart

    Urine colour was assessed using the Armstrong 8-point Urine Colour Chart. Scores range from 1, indicating very pale urine, to 8, indicating very dark urine. Higher scores indicate darker and generally more concentrated urine. Triplicate assessments were averaged to obtain one urine colour score for each scheduled urine sample.

    Measured: At the scheduled urine collection time points during each 24-hour experimental condition.

  14. Urinary Nitrogen Excretion

    Total urinary nitrogen will be measured from 24-hour urine samples and expressed as grams of nitrogen per 24 hours. This value will be used to estimate the contribution of protein metabolism to substrate oxidation calculations.

    Measured: 24-hour urine collection during each experimental condition

  15. Urinary Creatinine Excretion

    Urinary creatinine will be measured as a quality control marker for the plausibility and completeness of the 24-hour urine collection.

    Measured: 24-hour urine collection during each experimental condition

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start1 Nov 2025
  3. Primary completion24 Apr 2026
  4. Study completion24 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Participants completed two experimental visits in a randomized two-period, two-sequence crossover design. Each participant received both test meals, one healthy-sustainable and one non-sustainable, in separate visits separated by a 7-day washout period. In one sequence, participants received the healthy-sustainable meal at T0 and the non-sustainable meal at T1; in the opposite sequence, participants received the non-sustainable meal at T0 and the healthy-sustainable meal at T1.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07808736
Sponsor's protocol ID
THERMOS-LUNCH
Other IDs
35689, 52401, 16510
Acronym
THERMOS-LUNCH
Status last verified
Sep 2026
First submitted
27 Aug 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared because this was not specifically planned in the approved informed consent procedure.

Publications

  • Scazzina F, Del Rio D, Benini L, Melegari C, Pellegrini N, Marcazzan E, Brighenti F. The effect of breakfasts varying in glycemic index and glycemic load on dietary induced thermogenesis and respiratory quotient. Nutr Metab Cardiovasc Dis. 2011 Feb;21(2):121-5. doi: 10.1016/j.numecd.2009.08.008.

    PubMed 19836218

Questions about this trial

What is this clinical trial studying?

A study testing Healthy-Sustainable Test Meal and Non-Sustainable Test Meal in people with Postprandial Metabolism and Healthy Volunteers, run by University of Parma at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diet-Induced Thermogenesis (time frame: Baseline and 0-240 minutes after test meal consumption during each experimental visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07808736, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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