ObesityNCT02939703
Integrating Quantitative Energetics Determines the Microbiome's Contribution to Energy Balance
A study testing Diet in people with Obesity, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
We propose to study the role of the gut microbiome in the development of obesity, and whether we can change the microbiome's contribution to host energy balance through diet. We have created a novel model that explicitly links the effects of microorganisms on human energy balance and modeled weight change, and will… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2017to 23 Jul 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
- Age 18 - 45 years, inclusive
- Weight stable (+/- 3 kg) during the 6 months prior to enrollment
- BMI ≤ 30 kg/m2
Who cannot join
- History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG, presence of cardiac pacemaker, implanted cardiac defibrillator)
- History of type 1 or type 2 diabetes
- Bleeding disorders
- Acute or chronic infections
- Hepatitis and/or cirrhosis
- Severe asthma or chronic obstructive pulmonary disease
Show all 29Show fewer
- Renal insufficiency or nephritis
- Thyroid dysfunction (suppressed TSH, elevated TSH if symptomatic, elevated thyroid stimulating hormone (TSH) if asymptomatic)
- Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
- Prior bariatric surgery
- Inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis
- Participants with strict dietary concerns (e.g. vegetarian or kosher diet, multiple food allergies, or allergies to food we will provide them during the study)
- Current use of polyethylene glycol (e.g. Dulcolax, Miralax, Gavilax)
- Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
- History of depression within < 5 years from screening visit or which, in the opinion of a medical investigator, will impact the participant's ability to complete the study
- History of eating disorders
- Cushing's disease or syndrome
- Untreated or inadequately controlled hypo- or hyperthyroidism
- Active rheumatoid arthritis or other inflammatory rheumatic disorder
- Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection.
- Tobacco use within the past 3 months
- Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at Screening.
- Unable to participate in MRI or MRS assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at Screening.
- Unable to tolerate MRI/MRS imaging or claustrophobia.
- Nickel allergy.
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
- Intolerance to acetaminophen use.
- History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces [150 mL] of wine or12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
- Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
We propose to study the role of the gut microbiome in the development of obesity, and whether we can change the microbiome's contribution to host energy balance through diet. We have created a novel model that explicitly links the effects of microorganisms on human energy balance and modeled weight change, and will use the power of metabolic ward studies to measure small changes in energy absorption, total daily energy expenditure, and/or food intake that affect long-term weight gain or loss. By integrating clinical measurements, bioreactor experiments, and mathematical modeling, we will be able to describe cause-and-effect mechanisms that will enable a quantification of the microbiota's contribution to weight gain and inspire future studies on the interactions of diet, the gut microbiome, and human physiology.
- Conditions
- Obesity
- Being tested
- Diet
- Keywords
- Adipose tissue, calorimetry, energy expenditure, microbiome
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Participants will consume either a Control Western Diet or a Microbiome Enhancer Diet.
| Study group | Role | What they receive |
|---|---|---|
| Control Western diet | Active comparator | Participants will consume a control western diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period. Receives: Other: Diet |
| Microbiome Enhancer diet | Experimental | Participants will consume an experimental microbiome enhancer diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for the protocol is the within-participant difference in fecal energy (via chemical oxygen demand, COD) normalized to the total daily energy intake and to the non-metabolizable marker PEG [COD (kcal) / PEG (g)].
Comparison within subject of control diet versus microbiome enhancer diet.
Measured: Days 24-29 vs. Days 53-58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start14 Jun 2017
- Primary completion20 Jul 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Steven R Smith, MD, Principal investigator, Study Principal InvestigatorRosa Krajmalnik-Brown, PhD, Principal investigator, Study Principal Investigator at Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939703
- Sponsor's protocol ID
- TRIMD FH 942699
- Status last verified
- Jun 2021
- First submitted
- 16 Sep 2016
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Igudesman D, Yu G, Dutta T, Carnero EA, Krajmalnik-Brown R, Smith SR, Corbin KD. Global Metabolite Profiling in Feces, Serum, and Urine Yields Insights into Energy Balance Phenotypes Induced by Diet-Driven Microbiome Remodeling. Am J Clin Nutr. 2025 Oct;122(4):1027-1041. doi: 10.1016/j.ajcnut.2025.08.003. Epub 2025 Aug 19.
PubMed 40835099Corbin KD, Carnero EA, Dirks B, Igudesman D, Yi F, Marcus A, Davis TL, Pratley RE, Rittmann BE, Krajmalnik-Brown R, Smith SR. Host-diet-gut microbiome interactions influence human energy balance: a randomized clinical trial. Nat Commun. 2023 May 31;14(1):3161. doi: 10.1038/s41467-023-38778-x.
PubMed 37258525Corbin KD, Krajmalnik-Brown R, Carnero EA, Bock C, Emerson R, Rittmann BE, Marcus AK, Davis T, Dirks B, Ilhan ZE, Champagne C, Smith SR. Integrative and quantitative bioenergetics: Design of a study to assess the impact of the gut microbiome on host energy balance. Contemp Clin Trials Commun. 2020 Aug 19;19:100646. doi: 10.1016/j.conctc.2020.100646. eCollection 2020 Sep.
PubMed 32875141
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Quantitative Energetics Determines the Microbiome's Contribution to Energy Balance
- ClinicalTrials.gov ID
- NCT02939703
- Acronym / sponsor ID
- TRIMD FH 942699
- Conditions
- Obesity
- Keywords
- Adipose tissue, calorimetry, energy expenditure, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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.
We propose to study the role of the gut microbiome in the development of obesity, and whether we can change the microbiome's contribution to host energy balance through diet. We have created a novel model that explicitly links the effects of microorganisms on human energy balance and modeled weight change, and will use the power of metabolic ward studies to measure small changes in energy absorption, total daily energy expenditure, and/or food intake that affect long-term weight gain or loss. By integrating clinical measurements, bioreactor experiments, and mathematical modeling, we will be able to describe cause-and-effect mechanisms that will enable a quantification of the microbiota's contribution to weight gain and inspire future studies on the interactions of diet, the gut microbiome, and human physiology.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Western diet | Active comparator | Other: DietParticipants will consume a control western diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period. |
| Microbiome Enhancer diet | Experimental | Other: DietParticipants will consume an experimental microbiome enhancer diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
- Age 18 - 45 years, inclusive
- Weight stable (+/- 3 kg) during the 6 months prior to enrollment
- BMI ≤ 30 kg/m2
Key exclusion criteria (29 listed)
- History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG, presence of cardiac pacemaker, implanted cardiac defibrillator)
- History of type 1 or type 2 diabetes
- Bleeding disorders
- Acute or chronic infections
- Hepatitis and/or cirrhosis
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 |
|---|---|---|
| DietParticipants will consume either a Control Western Diet or a Microbiome Enhancer Diet. | Other | Control Western diet, Microbiome Enhancer diet |
Primary outcome
The primary endpoint for the protocol is the within-participant difference in fecal energy (via chemical oxygen demand, COD) normalized to the total daily energy intake and to the non-metabolizable marker PEG [COD (kcal) / PEG (g)].
Time frame: Days 24-29 vs. Days 53-58
Comparison within subject of control diet versus microbiome enhancer diet.
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 30 Jun 2021.
- Derived from this study: PubMed 40835099Igudesman D, Yu G, Dutta T, Carnero EA, Krajmalnik-Brown R, Smith SR, Corbin KD. Global Metabolite Profiling in Feces, Serum, and Urine Yields Insights into Energy Balance Phenotypes Induced by Diet-Driven Microbiome Remodeling. Am J Clin Nutr. 2025 Oct;122(4):1027-1041. doi: 10.1016/j.ajcnut.2025.08.003. Epub 2025 Aug 19.
- Derived from this study: PubMed 37258525Corbin KD, Carnero EA, Dirks B, Igudesman D, Yi F, Marcus A, Davis TL, Pratley RE, Rittmann BE, Krajmalnik-Brown R, Smith SR. Host-diet-gut microbiome interactions influence human energy balance: a randomized clinical trial. Nat Commun. 2023 May 31;14(1):3161. doi: 10.1038/s41467-023-38778-x.
- Derived from this study: PubMed 32875141Corbin KD, Krajmalnik-Brown R, Carnero EA, Bock C, Emerson R, Rittmann BE, Marcus AK, Davis T, Dirks B, Ilhan ZE, Champagne C, Smith SR. Integrative and quantitative bioenergetics: Design of a study to assess the impact of the gut microbiome on host energy balance. Contemp Clin Trials Commun. 2020 Aug 19;19:100646. doi: 10.1016/j.conctc.2020.100646. eCollection 2020 Sep.
- Translational Research Institute for Metabolism and DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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.
Steven R Smith, MD principal investigator
Study Principal Investigator
Rosa Krajmalnik-Brown, PhD principal investigator
Study Principal Investigator at Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Obesity, run by AdventHealth Translational Research Institute 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 4 inclusion and 29 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 30 Jun 2021. 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?
The primary endpoint for the protocol is the within-participant difference in fecal energy (via chemical oxygen demand, COD) normalized to the total daily energy intake and to the non-metabolizable marker PEG [COD (kcal) / PEG (g)]. (time frame: Days 24-29 vs. Days 53-58). 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 NCT02939703, which also lists 3 linked publications.
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 30 Jun 2021.