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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939703
• Other study ID #: TRIMD FH 942699
• Status: Completed
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: July 23, 2019

Study information

• Verified date: June 2021
• Source: Translational Research Institute for Metabolism and Diabetes, Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 23, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Diet
Participants will consume either a Control Western Diet or a Microbiome Enhancer Diet.

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Institute for Metabolism and Diabetes, Florida	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 24-29 vs. Days 53-58

External Links

•   Translational Research Institute for Metabolism and Diabetes