Cardiometabolic Effects of Low-Fat and Full-Fat Dairy
2026년 5월 18일 업데이트: Kristina Petersen PhD, APD, FAHA, Penn State University
Cardiometabolic Effects of Low-Fat and Full-Fat Dairy in Healthy and Cardiometabolically At-Risk Adults
The purpose of this study is to find out if full-fat dairy and low-fat dairy have similar effects on risk factors for heart disease and diabetes.
During the study, participants will consume two types of dairy products: low-fat dairy (milk, yogurt, and cheese) and full-fat dairy (milk, yogurt, and cheese).
Each type of dairy will be consumed for 6 weeks with a ≥4-week break between.
Measures will be taken to evaluate blood cholesterol, blood sugar, body weight, inflammation, blood pressure, heart health and dietary intake at the beginning and end of each 6 week period.
연구 개요
상세 설명
The overarching goal of this clinical trial is to characterize and compare the effect of full-fat dairy to low-fat dairy on low density lipoprotein cholesterol (LDL-C) and other cardiometabolic disease (CMD) risk factors in healthy adults and those at risk for CMD. This goal will be achieved with the following objectives:
- Characterize the effect of full-fat dairy compared to low-fat dairy on LDL-C and other CMD risk factors in healthy adults and adults at risk for CMD after 6 weeks.
- Compare the effect of full-fat dairy to low-fat dairy in healthy adults vs. adults at risk for CMD after 6 weeks.
This clinical trial will test two hypotheses: 1) intake of 3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese) has equivalent effects on LDL-C and other CMD risk factors to 3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese) in adults with normal BMI and optimal/near optimal LDL-C, and in adults with overweight/obesity and elevated LDL-C after 6 weeks; 2) the effect of full-fat dairy on LDL-C and other CMD risk factors, compared to low-fat dairy, is equivalent in adults with normal BMI and optimal/near optimal LDL-C compared to adults with overweight/obesity and elevated LDL-C after 6 weeks. This trial is expected to demonstrate equivalent effects of full-fat and low-fat dairy on LDL-C and other CMD risk factors in both healthy and at-risk adults.
This is a randomized clinical trial with 2 groups of adults. Group 1 will include adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL). Group 2 will include adults with overweight/obesity (25-39.9 kg/m2) and elevated LDL-C (130-190 mg/dL). Within each group, subjects will undergo two 6-week dietary conditions in random sequence order, separated by a 4-week washout: 1) 3 cup-equivalents/day of full-fat dairy; 2) 3 cup-equivalents/day of low-fat dairy. Outcomes will be assessed at the start and end of each period.
연구 유형
중재적
등록 (추정된)
178
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kristina Petersen, PhD
- 전화번호: 814-865-7206
- 이메일: kup63@psu.edu
연구 연락처 백업
- 이름: Stacey Meily
- 전화번호: 814-863-8622
- 이메일: sas117@psu.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:
- BMI 18.5 to 39.9 kg/m2
- LDL-C ≤190 mg/dL assessed by the Modified Sampson-NIH Equation
- Currently consume milk, yogurt, and/or cheese daily
- Willing to eat 3 servings of dairy (milk, yogurt, cheese) for two 6-week periods during the study
Exclusion Criteria:
- Hemoglobin <13.2 g/dL for men or < 11.7 g/dL for women at screening
- Fasting triglycerides >350 mg/dL at screening
- ≥10% change in body weight within the 6 months prior to enrollment
- Blood pressure >140/90 mmHg at screening
- Fasting glucose ≥126 mg/dL
- Type 1 or type 2 diabetes
- Takes any (prescription or over-the-counter) anti-hypertensive, lipid-lowering, glucose-lowering or anti-inflammatory drugs, or drugs that alter body weight
- Intake of supplements that affect the outcomes of interest (i.e., lipids, blood pressure, glucose, body weight, inflammation and microbiome) and are unwilling to cease during the study period.
- Unwilling to refrain from starting to take any supplements, vitamins, nutritional products, or health foods that are not prescribed by a doctor for the duration of the study
- History of liver, kidney, or autoimmune disease
- Prior cardiovascular event (e.g., stroke, heart attack)
- Current pregnancy or intention of pregnancy within the next 12 months
- Lactation within the prior 6 months
- Dairy allergy/intolerance/sensitivity/dislike
- Antibiotic use within the prior four weeks
- Oral steroid use within the prior four weeks
- Use of tobacco or nicotine-containing products within the past 6 months
- History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
- Participation in another clinical trial within 60 days of baseline
- Currently following a restricted or weight-loss diet
- Prior bariatric surgery
- Intake of >14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
- Does not speak and/or understand English
- Unwilling to refrain from donating blood and/or plasma during the study
- Weight <110 lb
- Lactose intolerance or sensitivity
- Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study
- For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) concentration, or change in dose of thyroid medication within the last 6 months
- Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Healthy Adults
Adults with normal BMI (18.5 -24.9 kg/m2) and optimal/near optimal LDL-C (≤ 129 mg/dL).
|
3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese)
3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese)
|
|
실험적: Adults at risk for cardiometabolic diseases
Adults with overweight/obesity (25-39.9
kg/m2) and elevated LDL-C (130-190 mg/dL
|
3 cup-equivalents/day of full-fat dairy (milk, yogurt & cheese)
3 cup-equivalents/day of low-fat dairy (milk, yogurt & cheese)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
LDL-cholesterol change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
LDL-cholesterol will be calculated via the Modified Sampson-NIH Equation.
Change in LDL-cholesterol will be calculated as the mean of the end of intervention measures (i.e., mean of day 1 and day 2 values) minus the mean of the pre-intervention measures (i.e., mean of day 1 and day 2 values).
|
6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Apolipoprotein B change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Triglycerides change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Total cholesterol change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
HDL-cholesterol change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
non-HDL cholesterol change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Glucose change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
6 weeks
|
|
Insulin change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in micro IU/ml.
|
6 weeks
|
|
Fructosamine change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in umol/L.
|
6 weeks
|
|
Homeostatic model of insulin resistance (HOMA-IR) change
기간: 6 weeks
|
Calculated from insulin and glucose measured from a fasting blood sample.
Calculated as (insulin × glucose) / 22.5
|
6 weeks
|
|
C-reactive protein change
기간: 6 weeks
|
Assessed from fasting blood draw expressed in mg/L.
|
6 weeks
|
|
Body weight change
기간: 6 weeks
|
Measured in the fasting state using a calibrated electronic scale.
|
6 weeks
|
|
Brachial systolic and diastolic blood pressure change
기간: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Central systolic and diastolic blood pressure change
기간: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Carotid-femoral pulse wave velocity change
기간: 6 weeks
|
Measured in the fasting state using a SphymoCor Xcel (Atcor Medical)
|
6 weeks
|
|
Diet quality change
기간: 6 weeks
|
Healthy Eating Index-2020 assessed using 24-hour recalls
|
6 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kristina Petersen, PhD, The Pennsylvania State University
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 (추정된)
2026년 9월 8일
기본 완료 (추정된)
2028년 8월 31일
연구 완료 (추정된)
2028년 8월 31일
연구 등록 날짜
최초 제출
2026년 5월 18일
QC 기준을 충족하는 최초 제출
2026년 5월 18일
처음 게시됨 (실제)
2026년 5월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 18일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 기간
Study protocol and SAP will be uploaded to clinicaltrials.gov
prior to enrollment of the first participant
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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. .