HealthyNCT06494449
Effect of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on DIT
A study testing Higher protein and Lower protein in people with Healthy and Overweight and Obesity, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight and Obesity
- What is being tested?
- Higher protein and Lower protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2024to 27 Nov 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18 to 55 years of age, inclusive. There will be approximately equal numbers of men and women within the groups with overweight/obesity and normal weight.
- Individual has BMI of 18.5 to 24.9 kg/m2 or 27.0 to 34.9 kg/m2, inclusive.
- Individual has a REE (measured at the screening visit using indirect calorimetry) between 1,250 and 2,250 kcals/d.
- For premenopausal women, individual has a history of regular menstrual cycles (21-35 d per cycle) for at least 3 months prior to visit 1.
- Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- Individual is willing and able to undergo the scheduled study procedures.
- Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important cardiac, renal, hepatic, endocrine (i.e., diabetes), pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
- Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
- Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-d washout prior to visit 1 and the participant must be willing to refrain from use during the study.
- Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
- Individual has used an alpha-blocker, beta-blocker, or high-dose diuretic within 30 d of visit 1. Unstable use (initiation or change in dose) within 30 d of visit 1 of other antihypertensive medications is also exclusionary.
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- Unstable use (initiation or change in dose) within 30 d of visit 1 of thyroid hormone replacement medications.
- Unstable use (initiation or change in dose) within 30 d of visit 1 of sex hormones for contraception.
- Use of medications or supplements that may influence carbohydrate or fat metabolism, including but not limited to hypoglycemic medications and systemic (intravenous, intramuscular, or oral) or ≥1500 µg/d (topical, inhaled, intranasal, or dermal) corticosteroids within 30 d of visit 1.
- Use of any weight loss medication within 90 d of visit 1.
- Use of medications or supplements that may influence heart rate, including but not limited to stimulant medications (e.g., amphetamines, methylphenidates, etc.) within 30 d of visit 1.
- Individual has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
- Individual has had a weight change of ± 4.5 kg (10 lbs) in the previous 3 months.
- Individual has extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian).
- Individual is actively following a weight loss diet (even if maintaining body weight).
- Individual habitually consumes a diet with <10% or ≥ 20% of energy from protein.
- Individual regularly consumes (≥ 2 times per week) protein supplements (wash out is permitted).
- Individual has a history of bariatric surgery or is actively attempting to lose or gain body weight.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- History of any major trauma or major surgical event within 2 months of visit 1.
- Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
- Individual has an allergy, sensitivity or intolerance to any components of the study meals.
- Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- Individual has been exposed to any non-registered drug product within 30 days prior to screening.
- Individual has a current or recent history (within 12 months prior to screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: A Randomized, Crossover Trial to Assess the Effects of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on Diet Induced Thermogenesis in Adults With Overweight or Obesity
The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity.
- Conditions
- Healthy, Overweight and Obesity
- Being tested
- Higher protein, Lower protein
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher proteinOther
An acute mixed meal containing higher protein
Lower proteinOther
An acute mixed meal containing lower protein
| Study group | Role | What they receive |
|---|---|---|
| Higher protein | Experimental | Not described Receives: Other: Higher protein |
| Lower protein | Active comparator | Not described Receives: Other: Lower protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Induced Thermogenesis (DIT) AUC
Change in DIT assessed as the area under the curve (AUC)
Measured: Pre-consumption (0 minutes) to 300 minutes
Secondary outcomes (4)
DIT niAUC
Change in DIT assessed as the net incremental area under the curve (niAUC)
Measured: Pre-consumption (0 minutes) to 300 minutes
Carbohydrate oxidation
Change in carbohydrate oxidation assessed as the AUC and niAUC
Measured: Pre-consumption (0 minutes) to 300 minutes
Fat oxidation
Change in fat oxidation assessed as the AUC and niAUC
Measured: Pre-consumption (0 minutes) to 300 minutes
Respiratory Exchange Ratio (RER)
Change in RER assessed as the AUC and niAUC
Measured: Pre-consumption (0 minutes) to 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start8 Aug 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Sponsor
- Investigators
- Kevin C. Maki, PhD, Study director, MB Clinical Research & Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494449
- Sponsor's protocol ID
- MB-2412
- Status last verified
- Sep 2024
- First submitted
- 2 Jul 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover Trial to Assess the Effects of Acute Intake of Meals Containing Higher vs. Lower Energy From Protein on Diet Induced Thermogenesis in Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06494449
- Acronym / sponsor ID
- MB-2412
- Conditions
- Healthy, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 10 Jul 2024 (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.
The objective of this trial is to assess the effects of acute intake of mixed meals containing higher vs. lower energy from protein on diet induced thermogenesis (DIT) in adults with overweight or obesity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher protein | Experimental | Other: Higher protein |
| Lower protein | Active comparator | Other: Lower protein |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female 18 to 55 years of age, inclusive. There will be approximately equal numbers of men and women within the groups with overweight/obesity and normal weight.
- Individual has BMI of 18.5 to 24.9 kg/m2 or 27.0 to 34.9 kg/m2, inclusive.
- Individual has a REE (measured at the screening visit using indirect calorimetry) between 1,250 and 2,250 kcals/d.
- For premenopausal women, individual has a history of regular menstrual cycles (21-35 d per cycle) for at least 3 months prior to visit 1.
- Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
Key exclusion criteria (26 listed)
- Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important cardiac, renal, hepatic, endocrine (i.e., diabetes), pulmonary, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
- Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
- Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-d washout prior to visit 1 and the participant must be willing to refrain from use during the study.
- Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
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 |
|---|---|---|
| Higher proteinAn acute mixed meal containing higher protein | Other | Higher protein |
| Lower proteinAn acute mixed meal containing lower protein | Other | Lower protein |
Primary outcome
Diet Induced Thermogenesis (DIT) AUC
Time frame: Pre-consumption (0 minutes) to 300 minutes
Change in DIT assessed as the area under the curve (AUC)
4 secondary outcomes
DIT niAUC
Time frame: Pre-consumption (0 minutes) to 300 minutes
Carbohydrate oxidation
Time frame: Pre-consumption (0 minutes) to 300 minutes
Fat oxidation
Time frame: Pre-consumption (0 minutes) to 300 minutes
Respiratory Exchange Ratio (RER)
Time frame: Pre-consumption (0 minutes) to 300 minutes
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 6 Apr 2025.
- 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.
Kevin C. Maki, PhD study director
MB Clinical Research & Consulting, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher protein and Lower protein in people with Healthy and Overweight and Obesity, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
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 26 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 6 Apr 2025. 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 United States. 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 (DIT) AUC (time frame: Pre-consumption (0 minutes) to 300 minutes). 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 6 Apr 2025.