Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Integrating Quantitative Energetics Determines the Microbiome's Contribution to Energy Balance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02939703
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Arizona State University
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Brief 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 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.

Condition or disease Intervention/treatment Phase
Obesity Other: Diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Integrating Quantitative Energetics Determines the Microbiome's Contribution to Energy Balance
Actual Study Start Date : December 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Active Comparator: Control Western diet
Participants will consume a control western diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period.
Other: Diet
Participants will consume either a Control Western Diet or a Microbiome Enhancer Diet.

Experimental: Microbiome Enhancer diet
Participants will consume an experimental microbiome enhancer diet prepared by our metabolic research kitchen for an outpatient period followed by an inpatient period
Other: Diet
Participants will consume either a Control Western Diet or a Microbiome Enhancer Diet.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
  2. Age 18 - 45 years, inclusive
  3. Weight stable (+/- 3 kg) during the 6 months prior to enrollment
  4. BMI ≤ 30 kg/m2

Exclusion Criteria:

  1. 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)
  2. History of type 1 or type 2 diabetes
  3. Bleeding disorders
  4. Acute or chronic infections
  5. Hepatitis and/or cirrhosis
  6. Severe asthma or chronic obstructive pulmonary disease
  7. Renal insufficiency or nephritis
  8. Thyroid dysfunction (suppressed TSH, elevated TSH if symptomatic, elevated thyroid stimulating hormone (TSH) if asymptomatic)
  9. Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
  10. Prior bariatric surgery
  11. 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
  12. 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)
  13. Current use of polyethylene glycol (e.g. Dulcolax, Miralax, Gavilax)
  14. Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
  15. 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
  16. History of eating disorders
  17. Cushing's disease or syndrome
  18. Untreated or inadequately controlled hypo- or hyperthyroidism
  19. Active rheumatoid arthritis or other inflammatory rheumatic disorder
  20. Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection.
  21. Tobacco use within the past 3 months
  22. Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at Screening.
  23. 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.
  24. Unable to tolerate MRI/MRS imaging or claustrophobia.
  25. Nickel allergy.
  26. Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
  27. Intolerance to acetaminophen use.
  28. 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.
  29. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939703


Contacts
Layout table for location contacts
Contact: Recruitment Department 407-303-7100 trimd@flhosp.org

Locations
Layout table for location information
United States, Florida
Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department    407-303-7100    tri@flhosp.org   
Principal Investigator: Steven R Smith, MD         
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
Arizona State University
Investigators
Layout table for investigator information
Principal Investigator: Steven R Smith, MD Study Principal Investigator
Principal Investigator: Rosa Krajmalnik-Brown, PhD Study Principal Investigator at Arizona State University
  Study Documents (Full-Text)

Documents provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Informed Consent Form  [PDF] January 15, 2019


Additional Information:
Layout table for additonal information
Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida
ClinicalTrials.gov Identifier: NCT02939703     History of Changes
Other Study ID Numbers: TRIMD FH 942699
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
Adipose tissue
calorimetry
energy expenditure
microbiome