Clinical trial NCT03528031: Habitual Diet and Avocado Trial
Official title: Habitual Diet and Avocado Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra-abdominal Fat
Metabolic Syndrome
High Cholesterol
Triglycerides High
Diet Habit
High Blood Sugar
Liver Fat
Dietary Modification
HDL Cholesterol, Low Serum
Cardiovascular Diseases
High Density Lipoprotein Deficiency
Low-density-lipoprotein-type
Cardiovascular Risk Factor
Diabetes
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 1008
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical trial aims to assess the effect of providing one avocado per day on established parameters of health in comparison with a control group maintaining their habitual diets. Participants are pre-screened over the telephone initially to assess eligibility and likelihood of compliance. For those that remain eligible, additional screening is conducted at a study visit. Participants' eligibility is confirmed by the data entry system on the trial website when the Inclusion/Exclusion form is complete and entered. Randomization is performed automatically by the data entry system using a block design and stratified by site. Participants are randomly assigned to one of two equally sized groups. Neither participants nor staff will be blinded to intervention assignment. Both groups are instructed to continue to follow their habitual diet but the intervention group will receive one avocado per day. Participants are followed for outcomes for a six-month period.
Primary purpose: PREVENTION

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).

Detailed description: Preliminary evidence suggests that consumption of avocados can modulate body weight, food intake and markers of metabolic syndrome and may reduce visceral adiposity. Visceral adipose tissue is positively correlated with risk of cardiometabolic syndrome that predisposes to cardiovascular disease and diabetes. The Habitual Diet and Avocado Trial (HAT) aims to investigate an impactful outcome (visceral fat reduction) in a relevant population (Americans with an increased weight circumference) with a reasonable lifestyle modification (consumption of 1 avocado per day). HAT will evaluate the effect of providing one avocado per day for consumption over a 6 month period on established health parameters, including visceral adiposity, hepatic lipid content, markers of metabolic syndrome and high sensitivity C-reactive protein (hsCRP) when compared to a habitual diet. Blood specimens will be drawn and analyzed for fasting total cholesterol, triglyceride, HDL-C, glucose, insulin, hsCRP and RBC fatty acid profiles. Two non-contrast MRIs will be performed (at screening to assess eligibility and final participant visit 8 for randomized participants) to assess the volume of visceral adipose tissue and hepatic fat fraction. Four 24-hour dietary recalls will be conducted for study participants to capture dietary intake data. Questionnaires include the following: health and demographic including eating habits and physical activity; diet, food and avocado satisfaction (intervention group only); quality of life; and quality of sleep.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visceral adiposity
timeFrame: Visit 1 (Screening, -2 to 0 weeks) and Visit 8 (26 weeks)
Secondary outcomes:
measure: Hepatic lipid content
timeFrame: Visit 1 (Screening, -2 to 0 weeks and Visit 8 (26 weeks)
measure: Metabolic syndrome markers (serum triglycerides, serum cholesterol, fasting serum glucose, fasting insulin)
timeFrame: Visit 2 (Baseline visit 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks)
measure: High-sensitivity C-reactive protein (hs-CRP)
timeFrame: Visit 2 (baseline/randomization, Week 0), Visit 5 (12 weeks), Visit 8 (26 weeks)
measure: Red blood cell (RBC) monounsaturated fat/polyunsaturated fat (MUFA/PUFA) ratio
timeFrame: Visit 2 (Baseline/Randomization Visit, 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks)
measure: Blood pressure
timeFrame: 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)
measure: Weight
timeFrame: Visit 2 (baseline/randomization), Visit 5 (12 weeks) and Visit 8 (26 weeks-final)
measure: Waist circumference
timeFrame: Visit 1 (screening -2 to 0 weeks), Visit 2 (baseline/randomization 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks)
measure: Diet, Food and Avocado Satisfaction
timeFrame: Visit 2 (baseline/randomization, 0 weeks), Visit 5 (12 weeks), Visit 8 (26 weeks)
measure: Quality of life RAND 36-Item Short Form Survey Instrument (SF-36)
timeFrame: Visit 2 (baseline), Visit 5 (12 weeks) and Visit 8 (26 weeks-final)
measure: Quality of Life RAND 20-Item Short Form Survey (SF-20)
timeFrame: Visit 3 (4 weeks), Vist 4 (8 weeks) Visit 6 (16 weeks), Visit 7 (20 weeks)
measure: Sleep quality
timeFrame: Visit 2 (baseline), Visit 5 (12 weeks) and Visit 8 (26 weeks-final)
measure: 24-hour diet recall
timeFrame: Visit 1 (screening, -2 to 0 weeks), Visit 4 (8 weeks), visit 6 (16 weeks), Visit 8 (26 weeks)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Los Angeles
country: United States
facility: University of California Los Angles (UCLA)
state: California
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: University Park
country: United States
facility: Pennysylvania State University
state: Pennsylvania
Study officials:
affiliation: Wake Forest University Health Sciences
name: David Reboussin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.