Weight LossNCT04440826
Thermic Effect of Three Different Meals in Healthy Women
A study testing Whole Food Meal, Processed Food Meal and Gluten-free and lactose-free in people with Weight Loss and Obesity, run by Skidmore College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- Whole Food Meal, Processed Food Meal and Gluten-free and lactose-free
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2015to 30 May 2015
- 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 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.
About this study
Official title: Dietary Induced Thermogenic Differences After Consumption of an Unrefined Meal, a Gluten-free Meal, and a Highly Processed Meal
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.
- Conditions
- Weight Loss, Obesity
- Being tested
- Whole Food Meal, Processed Food Meal, Gluten-free and lactose-free
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food MealOther
Whole foods meal
Processed Food MealOther
Processed food meal
Gluten-free and lactose-freeOther
Gluten-free and lactose-free food meal
| Study group | Role | What they receive |
|---|---|---|
| Whole Food Meal | Active comparator | Whole foods meal - grilled cheese and drink meal Receives: Other: Whole Food Meal |
| Processed Food Meal | Experimental | Highly processed foods - grilled cheese and drink meal Receives: Other: Processed Food Meal |
| Gluten-Free and Lactose-Free Meal | Experimental | Gluten-free and lactose-free foods - grilled cheese and drink meal Receives: Other: Gluten-free and lactose-free |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion
Secondary outcomes (4)
Blood Glucose Response
Change in postprandial blood glucose compared baseline
Measured: Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
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
Measured: Baseline 0 minutes, and 60, 120, 180 minutes postprandial
Heart Rate
Measure heart rate following the resting metabolic rate test
Measured: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Blood Pressure
Measure blood pressure following the resting metabolic rate test
Measured: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start23 Feb 2015
- Primary completion30 May 2015
- Study completion30 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Hoehn, MPH, Study chair, Skidmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440826
- Sponsor's protocol ID
- 1502-441
- Status last verified
- Apr 2024
- First submitted
- 11 Jun 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Induced Thermogenic Differences After Consumption of an Unrefined Meal, a Gluten-free Meal, and a Highly Processed Meal
- ClinicalTrials.gov ID
- NCT04440826
- Acronym / sponsor ID
- 1502-441
- Conditions
- Weight Loss, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Study start
- 23 Feb 2015 (actual)
- Primary completion
- 30 May 2015 (actual)
- Study completion
- 30 May 2015 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole Food Meal | Active comparator | Other: Whole Food MealWhole foods meal - grilled cheese and drink meal |
| Processed Food Meal | Experimental | Other: Processed Food MealHighly processed foods - grilled cheese and drink meal |
| Gluten-Free and Lactose-Free Meal | Experimental | Other: Gluten-free and lactose-freeGluten-free and lactose-free foods - grilled cheese and drink meal |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Food MealWhole foods meal | Other | Whole Food Meal |
| Processed Food MealProcessed food meal | Other | Processed Food Meal |
| Gluten-free and lactose-freeGluten-free and lactose-free food meal | Other | Gluten-Free and Lactose-Free Meal |
Primary outcome
Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis
Time frame: TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion
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)
4 secondary outcomes
Blood Glucose Response
Time frame: Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
Change in Hunger and Palatability Scores and Energy Level
Time frame: Baseline 0 minutes, and 60, 120, 180 minutes postprandial
Heart Rate
Time frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Blood Pressure
Time frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Hoehn, MPH study chair
Skidmore College
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food Meal, Processed Food Meal and Gluten-free and lactose-free in people with Weight Loss and Obesity, run by Skidmore College.
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 1 inclusion and 1 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis (time frame: TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.