Diet Intervention and GEnetic STudy (DIGEST-Pilot)

NCT01658137 | Unknown

• 1 other identifier: DIGEST-Pilot
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Genetic factors contribute to risk factors for cardiovascular disease, such as blood lipids, blood pressure, obesity, diabetes, and may also influence dietary choices, physical activity, and responses to stress. The most robust genetic variant associated with myocardial infarction (MI) is the 9p21 variant, which may raise the risk of MI by up to 40% in those who carry 2 copies of the gene. The investigators recently found that among those who carry the 9p21 variant, the risk of MI may be "turned off" if individuals eat a diet high in fruits and vegetables. The investigators seek to determine how a "prudent" or "anti-inflammatory" diet interacts with the 9p21 risk allele to alter the risk of MI.

Conditions

Cardiovascular Diseases; Inflammation; Dyslipidemias; Blood Pressure; Hyperglycemia

Keywords

diet; dietary pattern; gene; gene expression; epigenomics; diet-gene interaction; inflammation; 9p21; fruits; vegetables

Outcome Measures

Primary Outcomes (2)

• gene expression measuring ANRIL production

  baseline and 2 weeks

• epigenetic marks

  baseline and 2 weeks

Secondary Outcomes (12)

• high-sensitivity C-reactive protein

  baseline and 2 weeks

• interferon-alpha-21

  baseline and 2 weeks

• interferon-gamma

  baseline and 2 weeks

• interleukin-1-alpha

  baseline and 2 weeks

• total cholesterol

  baseline and 2 weeks

Study Arms (2)

Typical Western Diet

ACTIVE COMPARATOR

The comparator dietary pattern ("Typical Western Diet") approximates the inflammatory dietary pattern typically consumed by North Americans. It contains refined grains, processed foods, dairy fat, meats, sugar and high glycemic index foods, and few fruits, nuts, legumes, and vegetables. The fruits and vegetables are highly processed (e.g. juices) and lower in micronutrients than those in the intervention diet. The saturated fat content of this diet does not meet national guidelines for health. The polyunsaturated fat:saturated fat ratio is \~0.5 (low).

Other: Typical Western Diet

Prudent Diet

EXPERIMENTAL

The experimental dietary pattern ("Prudent Diet") is based on intakes of foods hypothesized to have beneficial effects on inflammation and long-term health. This dietary pattern includes micronutrient and macronutrient levels consistent with healthy eating in epidemiological studies and randomized controlled trials. The diet is constructed with low-fat dairy products, fish, chicken, and lean meats to minimize saturated fat and increase protein and calcium. The diet is rich in fruits, vegetables, whole grains, nuts, legumes, and seeds that are good sources of potassium, magnesium, and dietary fiber. This diet provides a 'favorable' macronutrient profile that is low in saturated fat, has a polyunsaturated/saturated fat ratio of \~1.0 (high), and low in high glycemic index carbohydrates.

Other: Prudent Diet

Interventions

Prudent Diet OTHER

This intervention lasts 2 weeks (14 days).

Prudent Diet

Typical Western Diet OTHER

This intervention lasts 2 weeks (14 days).

Typical Western Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• non-smokers
• Body-Mass-Index \<=30 kg/m\^2
• willing and able to cook, prepare, and eat provided study foods

You may not qualify if:

• Aged below 18 years or above 80 years
• current tobacco smoking
• Body mass index above 30 kg/m2
• Unwillingness or inability to cook, prepare and eat provided study foods (e.g. for medical, philosophical, or religious reasons)
• Excessive use of alcohol (\>14 drinks/week in men; \>7 drinks/week in women)
• Significant morbidity that would interfere with participation or assessment, including :
• Cancer
• HIV
• chronic renal disease
• renal failure
• Hepatitis/Jaundice
• Liver Disease
• Chronic Obstructive Pulmonary Disease
• Inflammatory bowel disease (Crohn's / Colitis)
• High blood or urine sugar/diabetes

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (6)

• Anand SS, Yusuf S. Stemming the global tsunami of cardiovascular disease. Lancet. 2011 Feb 12;377(9765):529-32. doi: 10.1016/S0140-6736(10)62346-X. Epub 2011 Feb 4. No abstract available.

  PMID: 21295845 BACKGROUND

• O'Donnell CJ, Nabel EG. Genomics of cardiovascular disease. N Engl J Med. 2011 Dec 1;365(22):2098-109. doi: 10.1056/NEJMra1105239. No abstract available.

  PMID: 22129254 BACKGROUND

• McPherson R, Pertsemlidis A, Kavaslar N, Stewart A, Roberts R, Cox DR, Hinds DA, Pennacchio LA, Tybjaerg-Hansen A, Folsom AR, Boerwinkle E, Hobbs HH, Cohen JC. A common allele on chromosome 9 associated with coronary heart disease. Science. 2007 Jun 8;316(5830):1488-91. doi: 10.1126/science.1142447. Epub 2007 May 3.

  PMID: 17478681 BACKGROUND

• Do R, Xie C, Zhang X, Mannisto S, Harald K, Islam S, Bailey SD, Rangarajan S, McQueen MJ, Diaz R, Lisheng L, Wang X, Silander K, Peltonen L, Yusuf S, Salomaa V, Engert JC, Anand SS; INTERHEART investigators. The effect of chromosome 9p21 variants on cardiovascular disease may be modified by dietary intake: evidence from a case/control and a prospective study. PLoS Med. 2011 Oct;8(10):e1001106. doi: 10.1371/journal.pmed.1001106. Epub 2011 Oct 11.

  PMID: 22022235 BACKGROUND

• Mente A, de Koning L, Shannon HS, Anand SS. A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Arch Intern Med. 2009 Apr 13;169(7):659-69. doi: 10.1001/archinternmed.2009.38.

  PMID: 19364995 BACKGROUND

• Hu FB, Rimm EB, Stampfer MJ, Ascherio A, Spiegelman D, Willett WC. Prospective study of major dietary patterns and risk of coronary heart disease in men. Am J Clin Nutr. 2000 Oct;72(4):912-21. doi: 10.1093/ajcn/72.4.912.

  PMID: 11010931 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation; Dyslipidemias; Hyperglycemia

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sonia S Anand, MD, PhD

  McMaster University; Hamilton Health Sciences Center; Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2012
• First Posted: August 6, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 7, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)