Status:
TERMINATED
APOA2 Gene, Diet, Inflammation and Gut Health
Lead Sponsor:
Tufts University
Conditions:
Inflammation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Nutrients and chemicals in food are able to regulate expression of genetic elements. Gene-nutrient interaction in response to unhealthy diets can increase an individual's risk, shifting the individual...
Detailed Description
The primary objectives of this application are 1. To use a diet intervention setting to rigorously evaluate the mechanisms responsible for the previously observed effects, focusing on gut microbiota a...
Eligibility Criteria
Inclusion
- Men and women
- 18 years or older
- Women who are not pregnant
- A BMI ranging between 27 and 34
Exclusion
- Unexplained elevation in serum transaminases (i.e. \>1.5 times the upper limit of normal) or with evidence of active liver disease, including primary biliary cirrhosis or pre-existing gallbladder disease
- Severe renal dysfunction (serum creatinine \>2.0mg/dL)
- Excessive alcohol consumption (\>2 drinks/day)
- Preexisting cardiovascular disease (CVD)
- Stable exertional angina pectoris requiring sublingual nitroglycerin within the prior 3 months
- Uncontrolled tyoe 2 diabetes (T2D) (fasting glucose \>126 mg/dl) or other significant endocrine disease.
- Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg).
- History of pancreatitis within 1 yr. prior to screening.
- Subjects on lipid lowering or diabetes medications.
- Smoking
- Pregnancy
- Body mass index (BMI) below 27 or greater than 34 kg/m2
- Participants will also be excluded for drug abuse, extreme dietary habits, multiple food allergies, extreme levels of physical or athletic activity, or by changes in body weight \>20 lbs. during the last 6 months
- Current use of antibiotics or during the previous 4 weeks.
- Inability to follow any of the experimental diets (including being vegetarian) or to perform the sampling required for this study
- Use of herbal supplements that may alter the gut microflora
- Autoimmune diseases
- Recent colonoscopy (within the previous two months)
- Use of antidiarrheal medication
- Thyroid diseases
- Use of omega-3 supplements (unless it is discontinued one month prior to the beginning of the study).
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03322449
Start Date
October 13 2017
End Date
April 30 2020
Last Update
September 5 2024
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, United States, 02111