Habitual Diet and Avocado Trial
HAT
1 other identifier
interventional
1,008
1 country
4
Brief Summary
The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per day for recommended consumption over a 6 month period in a cohort of approximately 1000 free-living participants with increased waist circumference in comparison with a control group that will maintain their habitual diets. Participants will be recruited and screened at 4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and Tufts University (250 per site).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedStudy Start
First participant enrolled
June 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedMarch 22, 2023
June 1, 2021
2.3 years
May 4, 2018
March 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Visceral adiposity
Non-contrast MRI scans will be performed to assess the volume of visceral adipose tissue. The outcome will be pre-post difference, compare the estimated mean change from baseline to follow-up in the 2 randomized groups with all tests of group differences performed according to the intent to treat.
Visit 1 (Screening, -2 to 0 weeks) and Visit 8 (26 weeks)
Secondary Outcomes (12)
Hepatic lipid content
Visit 1 (Screening, -2 to 0 weeks and Visit 8 (26 weeks)
Metabolic syndrome markers (serum triglycerides, serum cholesterol, fasting serum glucose, fasting insulin)
Visit 2 (Baseline visit 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks)
High-sensitivity C-reactive protein (hs-CRP)
Visit 2 (baseline/randomization, Week 0), Visit 5 (12 weeks), Visit 8 (26 weeks)
Red blood cell (RBC) monounsaturated fat/polyunsaturated fat (MUFA/PUFA) ratio
Visit 2 (Baseline/Randomization Visit, 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks)
Blood pressure
Visit 2 (baseline/randomization 0 weeks) Visit 3 (4 weeks), Visit 4 (8 weeks), Visit 5 (12 weeks), Visit 6 (16 weeks), Visit 7 (10 weeks), Visit 8 (26 weeks)
- +7 more secondary outcomes
Study Arms (2)
Intervention Daily Avocado
EXPERIMENTALParticipants 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.
Control Usual Diet and Lifestyle
NO INTERVENTIONParticipants 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.
Interventions
Participants follow their usual diet and lifestyle but also are provided with 1 avocado to consume per day for 6 months.
Eligibility Criteria
You may qualify if:
- Increased waist circumference defined as ≥35 inches for women, ≥40 inches for men
- At least 25 years old at screening
- Not currently eating more than 2 avocados per month (habitual intake in U.S.)
You may not qualify if:
- Does not eat avocados
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Loma Linda University
Loma Linda, California, 92354, United States
University of California Los Angles (UCLA)
Los Angeles, California, 90095, United States
Tufts University
Boston, Massachusetts, 02111, United States
Pennysylvania State University
University Park, Pennsylvania, 16802, United States
Related Publications (18)
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.
PMID: 25559009RESULTBertoli 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.
PMID: 26499033RESULTCespedes 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.
PMID: 27548405RESULTDhillon 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.
PMID: 27807041RESULTEstruch 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.
PMID: 16818923RESULTGower 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.
PMID: 25527677RESULTPaniagua 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.
PMID: 17384344RESULTRoss 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.
PMID: 9018491RESULTNational 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.
PMID: 12485966RESULTWien 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.
PMID: 24279738RESULTO'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.
RESULTDamani 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.
PMID: 39968784DERIVEDClarke 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.
PMID: 39886351DERIVEDYang 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.
PMID: 39641169DERIVEDMatthan 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.
PMID: 39128497DERIVEDDavis 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.
PMID: 38726886DERIVEDPetersen 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.
PMID: 38375072DERIVEDLichtenstein 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.
PMID: 35861827DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Reboussin, PhD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2018
First Posted
May 17, 2018
Study Start
June 19, 2018
Primary Completion
October 16, 2020
Study Completion
October 30, 2020
Last Updated
March 22, 2023
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available within 6 months of study completion.
- Access Criteria
- Data access requests will be reviewed by the Steering Committee. Requestors will be required to sign a Data Access Agreement.
Investigators may wish to perform ancillary studies using the HAT population, samples or other collected data. All ancillary studies must be approved by the HAT Steering Committee before being allowed access to study participant, samples or the database. De-identified individual participant data for all primary and secondary outcome measures will be made available to participating sites and for at the end of the study and for public use databases.