Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota (PROYO)
2026년 5월 5일 업데이트: André Marette, Laval University
A New Focus on Protein and the Gut Microbiota to Explain Health Benefits of Dairy Foods
The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning.
It is also well established that all proteins are not equal regarding their ability to promote health benefits.
Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance.
This was explained in part by modifications of the gut microbiota.
This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health.
This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention.
The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements.
The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans.
It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
75
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Julie Marois, M.Sc.
- 전화번호: 1-418-656-5258
- 이메일: julie.marois@fsaa.ulaval.ca
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V 0A6
- 모병
- INAF, Université Laval
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연락하다:
- Julie Marois, M.Sc.
- 전화번호: 1-418-656-5258
- 이메일: julie.marois@fsaa.ulaval.ca
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수석 연구원:
- André Marette, PhD
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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:
- Postmenopausal women (absence of menstruation for at least 1 year and FSH > 40 IU/L)
- BMI between 27.0 and 39.9 kg/m²
- Sedentary or moderately active
Exclusion Criteria:
- Body weight change greater than 5 kg in the 3 months preceding the study
- Currently dieting or following specific dietary patterns
- Previous or planned bariatric surgery
- Food allergies or intolerances (particularly dairy proteins and lactose)
- Serious or problematic health conditions (e.g., renal insufficiency, diabetes, Cushing's disease, Paget's disease, parathyroid disorders, inflammatory bowel disease, uncontrolled thyroid disease, etc.)
- Fracture within the past year
- Hormone therapy
- Medications affecting bone metabolism (e.g., osteoporosis treatments, anti-estrogen therapy for breast cancer, epilepsy treatments)
- Antibiotic use within the 6 months preceding the study
- Use of probiotic supplements (capsules)
- More than two alcoholic drinks per day
- Smoking
- Drug abuse
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Dairy yogurt
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Dairy yogurt: two serving daily
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활성 비교기: Plant-based yogurt
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Plant based yogurt: two servings daily
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위약 비교기: No yogurt
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No yogurt: zero serving yogurt
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in bone health
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of bone mineral density using Dual X-ray Absorptiometry scan
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At baseline and at the end of the intervention (12 weeks)
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Change in bone health
기간: At baseline and at the end of the intrevention (12 weeks)
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Assessment of bone turnover biomarkers (osteocalcin, c-telopeptide, Amino terminal propeptide of type 1 procollagen) (all in ng\mL)
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At baseline and at the end of the intrevention (12 weeks)
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Change in gut microbiota
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of global variation of the fecal microbiota
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At baseline and at the end of the intervention (12 weeks)
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Change in gut microbiota function
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of short-chain fatty acid (SCFA) in feces
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At baseline and at the end of the intervention (12 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in body weight
기간: At baseline and at the end of the intervention (12 weeks)
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At baseline and at the end of the intervention (12 weeks)
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Change in anthropometric measures
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of body mass index (BMI) using weight and height.
These two measurements will be combined to calculate BMI in kg/m2
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At baseline and at the end of the intervention (12 weeks)
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Change in anthropometric measure
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of waist circumference
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At baseline and at the end of the intervention (12 weeks)
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Change in body composition
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of changes in lean mass, fat mass and visceral fat mass (all in grams) using body composition by Dual X-ray Absorptiometry scan
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At baseline and at the end of the intervention (12 weeks)
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Change in skeletal muscle health
기간: At baseline and at the end of the intervention (12 weeks)
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muscle strength using handgrip strength tool (kg)
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At baseline and at the end of the intervention (12 weeks)
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Change in skeletal muscle health
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of physical performance using Timed Up and go Test
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At baseline and at the end of the intervention (12 weeks)
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Change in skeletal muscle health
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of functionnal capicity using 6-minute walk test)
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At baseline and at the end of the intervention (12 weeks)
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Change in Resting Metabolic Rate (RMR)
기간: At baseline and at the end of the intervention (12 weeks)
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Change in RMR using Calorimetry Device
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At baseline and at the end of the intervention (12 weeks)
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Change in Appetite and Satiety
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of leptin and ghrelin (both with same units of measurement)
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At baseline and at the end of the intervention (12 weeks)
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Change in Appetite and Satiety
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of appetite and satiety using visual analog scale
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At baseline and at the end of the intervention (12 weeks)
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Change in Eating behaviors
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of eating behaviors using Food Cravings Questionnaire (FCQ-T)
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At baseline and at the end of the intervention (12 weeks)
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Change in glycemia
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of fasting glucose concentration
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At baseline and at the end of the intervention (12 weeks)
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Change in insulinemia
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of fasting insulin concentration
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At baseline and at the end of the intervention (12 weeks)
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Change in lipid profile
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol
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At baseline and at the end of the intervention (12 weeks)
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Change in blood pressure
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of systolic and diastolic blood pressure
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At baseline and at the end of the intervention (12 weeks)
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Change in chronic inflammation
기간: At baseline and at the end of the intervention (12 weeks)
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Assessment of plasma high sensitive C-Reactive Protein (hs-CRP) concentrations
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At baseline and at the end of the intervention (12 weeks)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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)
2023년 11월 1일
기본 완료 (추정된)
2026년 6월 30일
연구 완료 (추정된)
2026년 12월 31일
연구 등록 날짜
최초 제출
2026년 5월 5일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PROYO 2022-108
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
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. .
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