ClinicalTrials.gg
CompletedNCT04440826Updated Apr 9, 2024

Thermic Effect of Three Different Meals in Healthy Women

An interventional study of Whole Food Meal and Processed Food Meal in Weight Loss and Obesity, sponsored by Skidmore College. Completed. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.

Primary conditionObesityRegistry: Weight LossReclassifiedWhy we changed it
Registry
Weight Loss — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. Weight Loss is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Obesity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Skidmore College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 3 months after the study started (first participant enrolled Feb 2015, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
Female
01

Study summary

This study will investigate the acute effect of three isocaloric meals varying in level of food processing, including a whole foods, gluten-free, and highly processed meal on energy metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.

Read the detailed description

A shift towards a diet containing large quantities of highly processed foods is believed to be a major contributor to the trends in obesity. The degree of processing of foods often affects the nutritional content of the constituents. A reduction in macromolecular complexity allows for an increased rate of digestion, meaning that the body does not have to work as hard to metabolize high processed food products. Thus, the purpose of this study is to investigate the effect on energy metabolism and blood glucose after the consumption of an unrefined, whole foods meal versus two highly processed food meals, including a common Western style meal and gluten-free meal in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals. It is hypothesized that an unrefined meal will induce a greater postprandial thermogenic response and a smaller blood glucose response than a highly processed or gluten-free meal. Additionally, it is hypothesized that a highly processed foods meal will be considered more palatable than an unrefined or gluten-free meal.

02

Conditions studied

  • Weight Loss
  • Obesity

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03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 11 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Skidmore College is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy females between the ages of 18 and 24 years that have BMIs that fall in the range of 18.5 kg/m2 to 28 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    Whole Food Meal

    Whole foods meal - grilled cheese and drink meal

    Other: Whole Food Meal

  • Experimental
    Processed Food Meal

    Highly processed foods - grilled cheese and drink meal

    Other: Processed Food Meal

  • Experimental
    Gluten-Free and Lactose-Free Meal

    Gluten-free and lactose-free foods - grilled cheese and drink meal

    Other: Gluten-free and lactose-free

Interventions

  • OtherWhole Food Meal

    Whole foods meal

  • OtherProcessed Food Meal

    Processed food meal

  • OtherGluten-free and lactose-free

    Gluten-free and lactose-free food meal

06

What researchers measure

Primary outcomes

  1. Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis

    The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Specifically, the thermic effect of each meal will be measured for a total of three hours at 45 minute intervals for 15 minutes at a time (45-60; 105-120; and 165-180 minutes)

    Time frame: TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion

Secondary outcomes

  1. Blood Glucose Response

    Change in postprandial blood glucose compared baseline

    Time frame: Baseline line 0 minutes, and 60, 120, 180 minutes postprandial

  2. Change in Hunger and Palatability Scores and Energy Level

    Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm

    Time frame: Baseline 0 minutes, and 60, 120, 180 minutes postprandial

  3. Heart Rate

    Measure heart rate following the resting metabolic rate test

    Time frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial

  4. Blood Pressure

    Measure blood pressure following the resting metabolic rate test

    Time frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2015 to primary completion in May 2015, 3 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 3 months is below that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2020
First posted
Jun 22, 2020
StartActual
Feb 23, 2015
Primary completionActual
May 30, 2015
CompletionActual
May 30, 2015
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04440826
Lead sponsor
Skidmore College
Responsible party
Sponsor
First posted
Jun 22, 2020
Start date
Feb 23, 2015
Primary completion
May 30, 2015
Completion
May 30, 2015
Last update
Apr 9, 2024

Study contacts

Mary Hoehn, MPH
study chair · Skidmore College

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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