- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07566325
Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of Inflammation.
4. května 2026 aktualizováno: 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).
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
38
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Sara Campbell
- Telefonní číslo: 630-469-6600
- E-mail: scampbell@mbclinicalresearch.com
Studijní záloha kontaktů
- Jméno: Caryn Adams
- E-mail: cwolfe@mbclinicalresearch.com
Studijní místa
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60616
- Illinois Institute of Technology
-
Kontakt:
- Chelsea Preiss
- Telefonní číslo: 312-567-5300
- E-mail: cpreiss@illinoistech.edu
-
-
Nevada
-
Las Vegas, Nevada, Spojené státy, 89154
- University of Nevada, Las Vegas
-
Kontakt:
- Neda Akhavan
- Telefonní číslo: 702-895-3011
- E-mail: neda.akhavan@unlv.edu
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
Jiný: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Composite measure of inflammatory biomarkers
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Homeostasis model assessments of insulin resistance (HOMA-IR)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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.
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
11. května 2026
Primární dokončení (Odhadovaný)
1. prosince 2026
Dokončení studie (Odhadovaný)
1. prosince 2026
Termíny zápisu do studia
První předloženo
29. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
29. dubna 2026
První zveřejněno (Aktuální)
5. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. května 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MB-2544
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Nadváha (BMI > 25)
-
Zuyd University of Applied SciencesStatistics Netherlands (CBS); LIME Limburg MeasuresZatím nenabírámeObezita | Nadváha (BMI > 25)
-
Universidad Autonoma de Nuevo LeonHospital Universitario Dr. Jose E. Gonzalez; Centro de Investigación y Asistencia...Nábor
-
Bioagile Therapeutics Pvt. Ltd.Dokončeno
-
University of ThessalyNábor
-
Arya HabibiDokončenoNadváha (BMI > 25) | Obesity (BMI>30)Írán
-
Mucosa Innovations, S.L.University of BarcelonaDokončenoZánět | BMI | Dysbióza | Nadváha (BMI > 25) | Chronická zánětlivá onemocnění | Hladiny cytokinů | TNF-a | Interleukin-1betaŠpanělsko
-
Istanbul UniversityIstanbul University Research FundDokončeno
-
York UniversityZatím nenabírámeNadváha (BMI > 25) | Muži a ženyKanada
-
Assuta Medical CenterTel-Aviv Sourasky Medical Center; Ariel UniversityZatím nenabíráme