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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07566325
Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of Inflammation.
24 de agosto de 2026 atualizado por: 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).
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
38
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Sara Campbell
- Número de telefone: 630-469-6600
- E-mail: scampbell@mbclinicalresearch.com
Estude backup de contato
- Nome: Caryn Adams
- E-mail: cwolfe@mbclinicalresearch.com
Locais de estudo
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60616
- Recrutamento
- Illinois Institute of Technology
-
Contato:
- Chelsea Preiss
- Número de telefone: 312-567-5300
- E-mail: cpreiss@illinoistech.edu
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89154
- Ainda não está recrutando
- University of Nevada, Las Vegas
-
Contato:
- Neda Akhavan
- Número de telefone: 702-895-3011
- E-mail: neda.akhavan@unlv.edu
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
|
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Outro: Control Group
3 study products per day will be provided with energy from avocado will be replaced with refined carbohydrate, especially added sugars
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Control foods will have similar energy contents to active foods, but energy from avocado will be replaced with refined carbohydrate, especially added sugars.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Composite measure of inflammatory biomarkers
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Homeostasis model assessments of insulin resistance (HOMA-IR)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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.
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de julho de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
1 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2026
Primeira postagem (Real)
5 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MB-2544
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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