APOA2 Gene, Diet, Inflammation and Gut Health

NCT03322449 | Terminated

• 1 other identifier: 2016-08911
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inflammation

Keywords

APOA2; Inflammation; gene; diet

Outcome Measures

Primary Outcomes (1)

• tryptophan metabolism

  The response of plasma metabolites related to tryptophan metabolism to diets differing in saturated fat and prebiotics content (animal-based diet versus plant-based diet) will vary in individuals carrying CC (n=20) and TT (n=20) genotypes at the common APOA2 -265T\>C single nucleotide polymorphism (SNP)

  1 week per intervention arm

Secondary Outcomes (8)

• Satiety assessment using plasma levels of leptin

  1 week per intervention arm

• adipose tissue metabolism

  1 week per intervention arm

• Plasma Lipoproteins

  1 week per intervention arm

• Gut microbiota diversity and composition

  1 week per intervention arm

• Plasma levels of Interleukin 6 to assess inflammatory status

  1 week per intervention arm

Study Arms (2)

Animal Diet

EXPERIMENTAL

during this Arm, the participants will receive a diet enriched in animal products

Other: Animal Diet

Plant Diet

EXPERIMENTAL

during this Arm, the participants will receive a diet enriched in plant products

Other: Plant Diet

Interventions

Animal Diet OTHER

during one week participants will receive food products enriched in animal products and with high content of fat and protein

Animal Diet

Plant Diet OTHER

during one week participants will receive plant products enriched in fiber and complex carbohydrates

Plant Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

• Corella D, Arnett DK, Tsai MY, Kabagambe EK, Peacock JM, Hixson JE, Straka RJ, Province M, Lai CQ, Parnell LD, Borecki I, Ordovas JM. The -256T>C polymorphism in the apolipoprotein A-II gene promoter is associated with body mass index and food intake in the genetics of lipid lowering drugs and diet network study. Clin Chem. 2007 Jun;53(6):1144-52. doi: 10.1373/clinchem.2006.084863. Epub 2007 Apr 19.

  PMID: 17446329 BACKGROUND

• Corella D, Peloso G, Arnett DK, Demissie S, Cupples LA, Tucker K, Lai CQ, Parnell LD, Coltell O, Lee YC, Ordovas JM. APOA2, dietary fat, and body mass index: replication of a gene-diet interaction in 3 independent populations. Arch Intern Med. 2009 Nov 9;169(20):1897-906. doi: 10.1001/archinternmed.2009.343.

  PMID: 19901143 BACKGROUND

• Smith CE, Tucker KL, Arnett DK, Noel SE, Corella D, Borecki IB, Feitosa MF, Aslibekyan S, Parnell LD, Lai CQ, Lee YC, Ordovas JM. Apolipoprotein A2 polymorphism interacts with intakes of dairy foods to influence body weight in 2 U.S. populations. J Nutr. 2013 Dec;143(12):1865-71. doi: 10.3945/jn.113.179051. Epub 2013 Oct 9.

  PMID: 24108135 BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jose M Ordovas, PHD

  JM-USDA HNRCA at Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: randomized crossover dietary intervention

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 26, 2017
• Study Start: October 13, 2017
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)