APOA2 Gene, Diet, Inflammation and Gut Health

Stopped early · Not applicable

Conditions studied: Inflammation

In brief

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 from health toward the development of chronic disease. The apolipoprotein A2 (APOA2) gene may either put individuals at risk for or protect from obesity in the presence of certain fats in food. The main purpose of this four-week study is to examine diet induced gene-nutrient interaction, with a focus on gut health, gut microbiota and inflammation in individuals who have either the CC or the TT form within a specific variant of the APOA2 Gene. The (2) one-week study diets, one plant based and the other animal based are separated by a (1) week return to your regular habitual without probiotic or prebiotic food products.

Key facts

Study ID

NCT03322449

Run by

Tufts University

People needed

37

Starts

2017-10-13

Expected to finish

2020-04-30

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women
• 18 years or older
• Women who are not pregnant
• A BMI ranging between 27 and 34

You may not qualify if…

• 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).

Where it is running

• Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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