- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07566325
Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of Inflammation.
24 août 2026 mis à jour par: Midwest Center for Metabolic and Cardiovascular Research
Effects of Avocado Consumption on Inflammation and Insulin Sensitivity in Adults With Elevated High Sensitivity-C-reactive Protein (Hs-CRP): A Randomized, Controlled Crossover Trial
The objective of this trial is to assess the effects of replacing foods high in refined carbohydrates, particularly added sugars, with avocado (isocaloric substitution) on biomarkers of inflammation and insulin sensitivity in adults with elevated hs-CRP and central adiposity.
Eligible participants will complete two 4-week interventions (1 avocado/d and control) separated by a 2-week washout phase.
Participants will complete a total of 7 clinic visits including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 4-week diet condition (visit 3 & 6 on day 21 and visits 4 & 7 on day 28), and one visit at the conclusion of the washout phase/start of the second condition (visit 5, day 0).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
38
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Sara Campbell
- Numéro de téléphone: 630-469-6600
- E-mail: scampbell@mbclinicalresearch.com
Sauvegarde des contacts de l'étude
- Nom: Caryn Adams
- E-mail: cwolfe@mbclinicalresearch.com
Lieux d'étude
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60616
- Recrutement
- Illinois Institute of Technology
-
Contact:
- Chelsea Preiss
- Numéro de téléphone: 312-567-5300
- E-mail: cpreiss@illinoistech.edu
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89154
- Pas encore de recrutement
- University of Nevada, Las Vegas
-
Contact:
- Neda Akhavan
- Numéro de téléphone: 702-895-3011
- E-mail: neda.akhavan@unlv.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Male or female 21 - 74 years of age, inclusive;
- Baseline hs-CRP ≥2 to <10 mg/L;
- Central adiposity (waist circumference ≥35 inches in women and ≥40 inches in men);
- Body mass index 25.0 to 39.9 kg/m2;
- Normally active and judged by the Investigator to be in generally good health, based on medical history and screening measurements;
- Willing to consume daily study foods during each diet condition;
- Willing to maintain his/her regular physical activity pattern throughout the study period;
- Willing to follow test day instructions (refrain from consumption of alcoholic beverages and participation in vigorous physical activity for 24 hours and tobacco and caffeine for 1 hour prior to each test visit);
- No plans to change smoking, vaping, or other nicotine use habits during the study period; and
- Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 days per cycle) for at least 3 months prior to visit 1;
- Understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
Exclusion Criteria:
- Calculated energy needs of <1800 kcal/d per the Mifflin-St. Jeor Equation, with an adjustment for energy expended in physical activity;
- Known metabolic disease (e.g., type 1 or type 2 diabetes, metabolic dysfunction-associated steatohepatitis, etc.);
- Laboratory test result(s) of clinical significance based on the judgment of the Principal Investigator or qualified designee, including fasting glucose ≥126 mg/dL;
- Positive urine test for illicit drugs at visit 1;
- Clinical atherosclerotic disease;
- History or presence of clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory or biliary disorder that, in the opinion of the Investigator, could interfere with the interpretation of the study results;
- History of cancer in the prior 2 years, except for non- melanoma skin cancer or carcinoma in situ of the cervix;
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening;
- Unstable use (defined as initiation or change in dose) of anti-hypertensive medication within 4 weeks of visit 1;
- Unstable use (defined as initiation or change in dose) of thyroid hormone replacement medication within 12 weeks of visit 1;
- Use of beta-adrenergic blockers and/or high-dose (>25 mg/d) thiazide diuretics within 4 weeks of visit 1;
- Use of diabetes medications including glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, alpha-glucosidase inhibitors, biguanides and biguanide combinations, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides and sulfonylureas and combination sulfonylureas within 4 weeks of visit 1;
- Unstable use (defined as initiation or change in dose, agent, or regimen) of statins within 4 weeks of visit 1;
- Use of lipid-altering drugs other than statins including, but not limited to bile acid sequestrants, cholesterol absorption inhibitors, or fibrates within 4 weeks of visit 1;
- Use of any prescription medication with known effects on inflammation (e.g., colchicine, systemic corticosteroids) within 4 weeks of visit 1;
- Frequent use (≥4 doses/week) of non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of visit 2;
- Use of weight-loss drugs (including over-the-counter medications and/or supplements) or participation in a structured weight loss program within 4 weeks prior to visit 1;
- Unstable use (initiation or change in dose) within 4 weeks of visit 1 of sex hormones. Multiphasic hormonal contraceptives in which the amount of sex hormone in the active pill varies by week (i.e., biphasic, triphasic, quadriphasic) are considered unstable doses of sex hormones and are exclusionary;
- History of bariatric surgery or plans to have any surgery during the study;
- History of any major trauma or major surgical event within 2 months of visit 1;
- Use of herbs or dietary supplements that may affect lipid metabolism, including but not limited to omega-3 fatty acid supplements with >500 mg of eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA), niacin (or its analogs) at doses >200 mg/d, sterol/stanol products, dietary fiber supplements, red rice yeast supplements, garlic supplements, and soy isoflavone supplements within 2 weeks of visit 2;
- Use of herbs and dietary supplements that may affect carbohydrate metabolism, including chromium picolinate, ginseng, cinnamon (as a supplement) and starch blockers within 2 weeks of visit 2;
- Recent weight change of ±4.5 kg (~10 lbs.) within 3 months prior to visit 1;
- Has signs and symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted by re-scheduling of the clinic visit);
- Extreme dietary habits (e.g., vegan, very low carbohydrate);
- History of an eating disorder (e.g., anorexia, bulimia nervosa, or binge eating) either diagnosed by a health professional or self-reported;
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period;
- Known allergy, sensitivity, or intolerance to any components of the study foods;
- Exposed to any non-registered drug product within 4 weeks of visit 1;
- Currently participating in another research study;
- Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g., once or twice a month) within 12 months of visit 1 is allowed but requires at least a 14-day washout prior to visit 2 and the participant must be willing to refrain from use during the study;
- Current or recent history (past 12 months of screening) or strong potential for illicit drug or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor); and
- Condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Avocado Group
1 avocado/day provided by 3 servings study products per day (muffins and pudding)
|
Active foods will provide the equivalent of one medium to large avocado/day in foods such as muffins and pudding, where avocado replaces refined carbohydrate, especially added sugars
|
|
Autre: Control Group
3 study products per day will be provided with energy from avocado will be replaced with refined carbohydrate, especially added sugars
|
Control foods will have similar energy contents to active foods, but energy from avocado will be replaced with refined carbohydrate, especially added sugars.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Composite measure of inflammatory biomarkers
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change from baseline for a composite measure of inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), interleukin-10 (IL-10), and tumor Necrosis Factor-alpha (TNF-α).
|
Change from baseline (day 0) to end of each condition (day 28)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Homeostasis model assessments of insulin resistance (HOMA-IR)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Changes in (HOMA-IR)
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Homeostasis model assessments of β-cell function (HOMA-B)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Changes in HOMA-B
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Matsuda index of insulin sensitivity
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in Matsuda index of insulin sensitivity
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Disposition index
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in disposition index
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
high sensitivity C-reactive protein (hs-CRP)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in hs-CRP
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Interleukin-6 (IL-6)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in IL-6
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Interleukin-1 beta (IL-1β)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in IL-1β
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Interleukin-10 (IL-10)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in IL-10
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Tumor Necrosis Factor-alpha (TNF-α)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in TNF-α
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Fibrinogen
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in fibrinogen
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Soluble Intercellular Adhesion Molecule-1 (sICAM-1)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in sICAM-1
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in sVCAM-1
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Total Cholesterol
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in total cholesterol
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Low-density lipoprotein cholesterol (LDL-C)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in LDL-C
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
High-density lipoprotein cholesterol (HDL-C)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in HDL-C
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Non-high-density lipoprotein cholesterol (non-HDL-C)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in non-HDL-C
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Triglycerides
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in triglycerides
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Apolipoprotein B (ApoB)
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in ApoB
|
Change from baseline (day 0) to end of each condition (day 28)
|
|
Systolic and diastolic blood pressures.
Délai: Change from baseline (day 0) to end of each condition (day 28)
|
Change in resting, seated systolic and diastolic blood pressures.
|
Change from baseline (day 0) to end of each condition (day 28)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 juillet 2026
Achèvement primaire (Estimé)
1 février 2027
Achèvement de l'étude (Estimé)
1 février 2027
Dates d'inscription aux études
Première soumission
29 avril 2026
Première soumission répondant aux critères de contrôle qualité
29 avril 2026
Première publication (Réel)
5 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MB-2544
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .