Avocado and Postprandial Responses

NCT ID: NCT06818032

Last Updated: 2025-03-28

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to see how adding avocado to a breakfast meal affects blood sugar control and signals of hunger and fullness after eating.

The investigators will test the effects of 3 breakfast meals on blood sugar control and signals of hunger and fullness after eating:

1. Whole-wheat bread and strawberry jam
2. Whole-wheat bread, strawberry jam, and avocado
3. Whole-wheat bread and strawberry jam (meal enriched with fat and fiber to mimic that of an avocado)

Participants will undergo 3 test periods, each separated by a week. Each test period consists of one day with set meals that the investigators will provide (breakfast, lunch, and dinner), and then the next morning, participants will eat a breakfast meal and have blood drawn several times over 4 hours.

Detailed Description

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Conditions

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Healthy Healthy Volunteer Healthy Volunteers Healthy Adult Healthy Male and Female Subjects Healthy Subjects Healthy Volunteers Only Healthy Non-smokers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Negative control breakfast

Participants will receive a breakfast with bread and jam, no avocado.

Group Type OTHER

Negative control

Intervention Type OTHER

Participants will be given a breakfast meal with 76 grams of bread and 60 grams of jam per 2000 daily calories.

Avocado addition breakfast

Participants will receive a breakfast with bread, jam, and avocado.

Group Type EXPERIMENTAL

Avocado

Intervention Type OTHER

Participants will be given a bread and jam breakfast (76 grams of bread and 60 grams of jam per 2000 daily calories) supplemented with 84 grams of avocado per 2000 daily calories.

Fat and fiber control breakfast

Participants will receive a breakfast with bread and jam, no avocado. The breakfast meal will be enriched with fat and fiber to mimic that of an avocado.

Group Type ACTIVE_COMPARATOR

Fat and fiber addition

Intervention Type OTHER

Participants will be given a bread and jam breakfast (76 grams of bread and 60 grams of jam per 2000 daily calories) supplemented with 13 grams of fat (mix of high-oleic safflower oil, safflower oil, palm oil, and macadamia nut oil) and 5.5 grams of fiber (mix of cellulose and pectin) per 2000 daily calories.

Interventions

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Negative control

Participants will be given a breakfast meal with 76 grams of bread and 60 grams of jam per 2000 daily calories.

Intervention Type OTHER

Avocado

Participants will be given a bread and jam breakfast (76 grams of bread and 60 grams of jam per 2000 daily calories) supplemented with 84 grams of avocado per 2000 daily calories.

Intervention Type OTHER

Fat and fiber addition

Participants will be given a bread and jam breakfast (76 grams of bread and 60 grams of jam per 2000 daily calories) supplemented with 13 grams of fat (mix of high-oleic safflower oil, safflower oil, palm oil, and macadamia nut oil) and 5.5 grams of fiber (mix of cellulose and pectin) per 2000 daily calories.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Biological sex males or females
* Age 21 to 65 years
* BMI between 18.5 and 34.9 kg/m2

Exclusion Criteria

* Actively pregnant or lactating women
* Diagnosis of prediabetes or diabetes (fasting glucose \>100 mg/dL)
* Current diagnosis of uncontrolled hypertension (systolic BP: \>160 mmHg, diastolic BP: \>95 mmHg), may receive treatment for hypertension as long as on a stable regimen for the previous one month
* Current diagnosis of uncontrolled hyperlipidemia (fasting total blood cholesterol \>200 mg/dL, fasting triglycerides \>200 mg/dL), may receive treatment for hyperlipidemia as long as on a stable regimen for the previous one month
* Presence of kidney disease, liver disease, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other chronic metabolic diseases or malabsorption syndromes, HIV, or inflammatory conditions (such as arthritis, asthma, Crohn's disease, inflammatory bowel disease, gout, Lupus)
* History of bariatric or certain other surgeries related to weight control
* Any medication used to lower blood glucose/antidiabetic medications \[including, but not limited to metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose cotransporter-2 (SGL2) inhibitors, thiazolidinediones, dipeptidyl peptidase (DPP)-IV inhibitors\] as well as medications affecting weight, appetite/hunger or gut motility.
* Smoking or use of other tobacco products (during 6 months prior to the start of the study)
* Antibiotic use during the intervention or for 3 weeks prior to any treatment period
* History of eating disorders or other significant food preferences that would interfere with the diet intervention (e.g., vegan lifestyle, very low-fat diets, high-protein diets)
* Allergies or adverse reactions to study foods (e.g., gluten intolerance), or food aversions that would interfere with diet adherence
* Body weight loss of \>10% within the last 6 months prior to study start
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
* Undergoing hormonal therapy of any kind, with the exception of a stable regime for the prior 6 months to study start.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avocado Nutrition Center

UNKNOWN

Sponsor Role collaborator

University of Vermont Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jana Kraft

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jana Kraft, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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Clinical Research Center, University of Vermont Medical Center

Burlington, Vermont, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Research Project Manager

Role: CONTACT

802-656-8827

Facility Contacts

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Clinical Research Project Manager

Role: primary

802-656-8827

References

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https://hassavocadoboard.com/happenings/2023-year-in-review/.

Reference Type BACKGROUND

Zhu L, Huang Y, Edirisinghe I, Park E, Burton-Freeman B. Using the Avocado to Test the Satiety Effects of a Fat-Fiber Combination in Place of Carbohydrate Energy in a Breakfast Meal in Overweight and Obese Men and Women: A Randomized Clinical Trial. Nutrients. 2019 Apr 26;11(5):952. doi: 10.3390/nu11050952.

Reference Type BACKGROUND
PMID: 31035472 (View on PubMed)

Wright J. Effect of high-carbohydrate versus high-monounsaturated fatty acid diet on metabolic control in diabetes and hyperglycemic patients. Clin Nutr. 1998 Sep;17 Suppl 2:35-45. doi: 10.1016/s0261-5614(98)80016-2. No abstract available.

Reference Type BACKGROUND
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U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th Edition.

Reference Type BACKGROUND

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Reference Type BACKGROUND
PMID: 27457635 (View on PubMed)

Pedreschi R, Uarrota V, Fuentealba C, Alvaro JE, Olmedo P, Defilippi BG, Meneses C, Campos-Vargas R. Primary Metabolism in Avocado Fruit. Front Plant Sci. 2019 Jun 26;10:795. doi: 10.3389/fpls.2019.00795. eCollection 2019.

Reference Type BACKGROUND
PMID: 31293606 (View on PubMed)

Park E, Edirisinghe I, Burton-Freeman B. Avocado Fruit on Postprandial Markers of Cardio-Metabolic Risk: A Randomized Controlled Dose Response Trial in Overweight and Obese Men and Women. Nutrients. 2018 Sep 12;10(9):1287. doi: 10.3390/nu10091287.

Reference Type BACKGROUND
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Nansel TR, Lipsky LM, Liu A. Greater diet quality is associated with more optimal glycemic control in a longitudinal study of youth with type 1 diabetes. Am J Clin Nutr. 2016 Jul;104(1):81-7. doi: 10.3945/ajcn.115.126136. Epub 2016 May 18.

Reference Type BACKGROUND
PMID: 27194309 (View on PubMed)

Muller M, Canfora EE, Blaak EE. Gastrointestinal Transit Time, Glucose Homeostasis and Metabolic Health: Modulation by Dietary Fibers. Nutrients. 2018 Feb 28;10(3):275. doi: 10.3390/nu10030275.

Reference Type BACKGROUND
PMID: 29495569 (View on PubMed)

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Reference Type BACKGROUND
PMID: 15505129 (View on PubMed)

Livesey G, Taylor R, Livesey HF, Buyken AE, Jenkins DJA, Augustin LSA, Sievenpiper JL, Barclay AW, Liu S, Wolever TMS, Willett WC, Brighenti F, Salas-Salvado J, Bjorck I, Rizkalla SW, Riccardi G, Vecchia C, Ceriello A, Trichopoulou A, Poli A, Astrup A, Kendall CWC, Ha MA, Baer-Sinnott S, Brand-Miller JC. Dietary Glycemic Index and Load and the Risk of Type 2 Diabetes: Assessment of Causal Relations. Nutrients. 2019 Jun 25;11(6):1436. doi: 10.3390/nu11061436.

Reference Type BACKGROUND
PMID: 31242690 (View on PubMed)

Ingram DK, Roth GS. Glycolytic inhibition: an effective strategy for developing calorie restriction mimetics. Geroscience. 2021 Jun;43(3):1159-1169. doi: 10.1007/s11357-020-00298-7. Epub 2020 Nov 12.

Reference Type BACKGROUND
PMID: 33184758 (View on PubMed)

Giuntini EB, Sarda FAH, de Menezes EW. The Effects of Soluble Dietary Fibers on Glycemic Response: An Overview and Futures Perspectives. Foods. 2022 Dec 6;11(23):3934. doi: 10.3390/foods11233934.

Reference Type BACKGROUND
PMID: 36496742 (View on PubMed)

Gillingham LG, Harris-Janz S, Jones PJ. Dietary monounsaturated fatty acids are protective against metabolic syndrome and cardiovascular disease risk factors. Lipids. 2011 Mar;46(3):209-28. doi: 10.1007/s11745-010-3524-y. Epub 2011 Feb 10.

Reference Type BACKGROUND
PMID: 21308420 (View on PubMed)

Ford NA, Spagnuolo P, Kraft J, Bauer E. Nutritional Composition of Hass Avocado Pulp. Foods. 2023 Jun 28;12(13):2516. doi: 10.3390/foods12132516.

Reference Type BACKGROUND
PMID: 37444254 (View on PubMed)

FoodData Central. Avocados, raw, California. Available online: https://fdc.nal.usda.gov/fdc-app.html#/food-details/171706/nutrients

Reference Type BACKGROUND

FruiTrop. Close-up avocado. In FruiTrop Magazine; Loeillet, D., Imbert, E., Eds.; Cirad: Montpellier, France, 2015; pp. 1-96.

Reference Type BACKGROUND

Akhlaghi M. The role of dietary fibers in regulating appetite, an overview of mechanisms and weight consequences. Crit Rev Food Sci Nutr. 2024;64(10):3139-3150. doi: 10.1080/10408398.2022.2130160. Epub 2022 Oct 4.

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PMID: 36193993 (View on PubMed)

Abdul-Ghani MA, Williams K, DeFronzo R, Stern M. Risk of progression to type 2 diabetes based on relationship between postload plasma glucose and fasting plasma glucose. Diabetes Care. 2006 Jul;29(7):1613-8. doi: 10.2337/dc05-1711.

Reference Type BACKGROUND
PMID: 16801587 (View on PubMed)

Other Identifiers

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STUDY00003379

Identifier Type: -

Identifier Source: org_study_id

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