Study Results
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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COMPLETED
NA
1008 participants
INTERVENTIONAL
2018-06-19
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Daily Avocado
Participants will follow their usual diet and lifestyle but also be provided with 1 avocado to consume per day for 6 months. To maximize compliance, participants will be provided with resources on how to choose, store and ripen avocados along with simple usage ideas. Specific nutrition guidance will not be provided. Participants will pick up fresh avocados every 2 weeks with minimal interaction with study personnel. Compliance visits will be conducted monthly.
Intervention Daily Avocado
Participants follow their usual diet and lifestyle but also are provided with 1 avocado to consume per day for 6 months.
Control Usual Diet and Lifestyle
Participants will be instructed to follow their usual diet and lifestyle. Participants will be allowed to consume up to 2 avocados per month, but avocado consumption will not be encouraged and no avocados will be provided. Compliance visits will be conducted monthly.
No interventions assigned to this group
Interventions
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Intervention Daily Avocado
Participants follow their usual diet and lifestyle but also are provided with 1 avocado to consume per day for 6 months.
Eligibility Criteria
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Inclusion Criteria
* At least 25 years old at screening
* Not currently eating more than 2 avocados per month (habitual intake in U.S.)
Exclusion Criteria
* Sensitive / allergic to avocados
* Allergies to latex or oral allergy syndrome
* Not willing or unable to undergo MRI scans
* Unstable medical condition such as on dialysis for renal disease, cardiac, gastrointestinal, or hepatic disease, cancer (non-melanoma skin cancer \>5 years ago acceptable, any cancer site \>10yrs without recurrence).
* Pregnant, lactating, intention of pregnancy
* Lost or gained 10 lbs of body weight in last year
* Following restricted or weight loss dietary patterns
* Unstable anti-anxiety / anti-depressive / anti-psychotic medication use defined as dose change within last 6 months
* Oral steroid use within the last 6 months longer than 7 days
* Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)
* Participation in another clinical intervention trial within 30 days of baseline
* PI judgment
25 Years
ALL
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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David Reboussin, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Loma Linda University
Loma Linda, California, United States
University of California Los Angles (UCLA)
Los Angeles, California, United States
Tufts University
Boston, Massachusetts, United States
Pennysylvania State University
University Park, Pennsylvania, United States
Countries
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References
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Berryman CE, West SG, Fleming JA, Bordi PL, Kris-Etherton PM. Effects of daily almond consumption on cardiometabolic risk and abdominal adiposity in healthy adults with elevated LDL-cholesterol: a randomized controlled trial. J Am Heart Assoc. 2015 Jan 5;4(1):e000993. doi: 10.1161/JAHA.114.000993.
Bertoli S, Leone A, Vignati L, Bedogni G, Martinez-Gonzalez MA, Bes-Rastrollo M, Spadafranca A, Vanzulli A, Battezzati A. Adherence to the Mediterranean diet is inversely associated with visceral abdominal tissue in Caucasian subjects. Clin Nutr. 2015 Dec;34(6):1266-72. doi: 10.1016/j.clnu.2015.10.003. Epub 2015 Oct 20.
Cespedes Feliciano EM, Tinker L, Manson JE, Allison M, Rohan T, Zaslavsky O, Waring ME, Asao K, Garcia L, Rosal M, Neuhouser ML. Change in Dietary Patterns and Change in Waist Circumference and DXA Trunk Fat Among Postmenopausal Women. Obesity (Silver Spring). 2016 Oct;24(10):2176-84. doi: 10.1002/oby.21589. Epub 2016 Aug 22.
Dhillon J, Tan SY, Mattes RD. Almond Consumption during Energy Restriction Lowers Truncal Fat and Blood Pressure in Compliant Overweight or Obese Adults. J Nutr. 2016 Dec;146(12):2513-2519. doi: 10.3945/jn.116.238444. Epub 2016 Nov 2.
Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. doi: 10.7326/0003-4819-145-1-200607040-00004.
Gower BA, Goss AM. A lower-carbohydrate, higher-fat diet reduces abdominal and intermuscular fat and increases insulin sensitivity in adults at risk of type 2 diabetes. J Nutr. 2015 Jan;145(1):177S-83S. doi: 10.3945/jn.114.195065. Epub 2014 Dec 3.
Paniagua JA, Gallego de la Sacristana A, Romero I, Vidal-Puig A, Latre JM, Sanchez E, Perez-Martinez P, Lopez-Miranda J, Perez-Jimenez F. Monounsaturated fat-rich diet prevents central body fat distribution and decreases postprandial adiponectin expression induced by a carbohydrate-rich diet in insulin-resistant subjects. Diabetes Care. 2007 Jul;30(7):1717-23. doi: 10.2337/dc06-2220. Epub 2007 Mar 23.
Ross R, Rissanen J, Pedwell H, Clifford J, Shragge P. Influence of diet and exercise on skeletal muscle and visceral adipose tissue in men. J Appl Physiol (1985). 1996 Dec;81(6):2445-55. doi: 10.1152/jappl.1996.81.6.2445.
National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
Wien M, Haddad E, Oda K, Sabate J. A randomized 3x3 crossover study to evaluate the effect of Hass avocado intake on post-ingestive satiety, glucose and insulin levels, and subsequent energy intake in overweight adults. Nutr J. 2013 Nov 27;12:155. doi: 10.1186/1475-2891-12-155.
O'Neil, et al. Avocado consumption by adults is associated with better nutrient intake, diet quality and some measures of adiposity: NHANES Survey, 2001-2012. Int Med Rev In press.
Damani JJ, Kris-Etherton PM, Lichtenstein AH, Matthan NR, Sabate J, Li Z, Reboussin D, Petersen KS. Effect of Daily Avocado Intake on Cardiovascular Health Assessed by Life's Essential 8: An Ancillary Study of HAT, a Randomized Controlled Trial. J Am Heart Assoc. 2025 Mar 4;14(5):e039130. doi: 10.1161/JAHA.124.039130. Epub 2025 Feb 19.
Clarke AE, LeBeau KS, Oda K, Segovia-Siapco G, Paalani M, Reboussin DM, Lichtenstein AH, Rajaram S, Sabate J. The Effect of Daily Avocado Intake on Food and Nutrient Displacement in a Free-Living Population with Abdominal Obesity. Curr Dev Nutr. 2024 Aug 27;8(10):104451. doi: 10.1016/j.cdnut.2024.104451. eCollection 2024 Oct.
Yang J, Lei OK, Bhute S, Kris-Etherton PM, Lichtenstein AH, Matthan NR, Petersen KS, Sabate J, Reboussin DM, Lovato L, Vitolins MZ, Rajaram S, Jacobs JP, Huang J, Taw M, Yang S, Li Z. Impact of daily avocado consumption on gut microbiota in adults with abdominal obesity: an ancillary study of HAT, a randomized controlled trial. Food Funct. 2025 Jan 2;16(1):168-180. doi: 10.1039/d4fo03806a.
Matthan NR, Lovato L, Petersen KS, Kris-Etherton PM, Sabate J, Rajaram S, Li Z, Reboussin DM, Lichtenstein AH. Effect of daily avocado consumption for 6 mo compared with habitual diet on red blood cell fatty acid profiles and association with cardiometabolic risk factors in individuals with abdominal obesity: a randomized trial. Am J Clin Nutr. 2024 Oct;120(4):794-803. doi: 10.1016/j.ajcnut.2024.08.002. Epub 2024 Aug 10.
Davis KM, Petersen KS, Matthan NR, Legro RS, Kris-Etherton PM. Effect of Incorporating 1 Avocado per Day Versus Habitual Diet on Vascular Function in Adults With Abdominal Obesity: An Ancillary Study of HAT, a Randomized Controlled Trial. J Am Heart Assoc. 2024 May 21;13(10):e030497. doi: 10.1161/JAHA.123.030497. Epub 2024 May 10.
Petersen KS, Smith S, Lichtenstein AH, Matthan NR, Li Z, Sabate J, Rajaram S, Segovia-Siapco G, Reboussin DM, Kris-Etherton PM. One Avocado per Day as Part of Usual Intake Improves Diet Quality: Exploratory Results from a Randomized Controlled Trial. Curr Dev Nutr. 2024 Jan 11;8(2):102079. doi: 10.1016/j.cdnut.2024.102079. eCollection 2024 Feb.
Lichtenstein AH, Kris-Etherton PM, Petersen KS, Matthan NR, Barnes S, Vitolins MZ, Li Z, Sabate J, Rajaram S, Chowdhury S, Davis KM, Galluccio J, Gilhooly CH, Legro RS, Li J, Lovato L, Perdue LH, Petty G, Rasmussen AM, Segovia-Siapco G, Sirirat R, Sun A, Reboussin DM. Effect of Incorporating 1 Avocado Per Day Versus Habitual Diet on Visceral Adiposity: A Randomized Trial. J Am Heart Assoc. 2022 Jul 19;11(14):e025657. doi: 10.1161/JAHA.122.025657. Epub 2022 Jul 5.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00047011
Identifier Type: -
Identifier Source: org_study_id
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