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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-14

Study Completion Date

2019-07-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Diet

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

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

Interventions

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Diet

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes