- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07566325
Assess the Effects of Replacing Foods High in Refined Carbohydrates With Avocado on Biomarkers of Inflammation.
2026년 8월 24일 업데이트: 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).
연구 개요
연구 유형
중재적
등록 (추정된)
38
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sara Campbell
- 전화번호: 630-469-6600
- 이메일: scampbell@mbclinicalresearch.com
연구 연락처 백업
- 이름: Caryn Adams
- 이메일: cwolfe@mbclinicalresearch.com
연구 장소
-
-
Illinois
-
Chicago, Illinois, 미국, 60616
- 모병
- Illinois Institute of Technology
-
연락하다:
- Chelsea Preiss
- 전화번호: 312-567-5300
- 이메일: cpreiss@illinoistech.edu
-
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Nevada
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Las Vegas, Nevada, 미국, 89154
- 아직 모집하지 않음
- University of Nevada, Las Vegas
-
연락하다:
- Neda Akhavan
- 전화번호: 702-895-3011
- 이메일: neda.akhavan@unlv.edu
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Avocado Group
1 avocado/day provided by 3 servings study products per day (muffins and pudding)
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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
|
|
다른: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Composite measure of inflammatory biomarkers
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Homeostasis model assessments of insulin resistance (HOMA-IR)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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.
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 2일
기본 완료 (추정된)
2027년 2월 1일
연구 완료 (추정된)
2027년 2월 1일
연구 등록 날짜
최초 제출
2026년 4월 29일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 24일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MB-2544
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .