Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota (PROYO)
2026年5月5日 更新者：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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
75
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Julie Marois, M.Sc.
- 電話番号：1-418-656-5258
- メール：julie.marois@fsaa.ulaval.ca
研究場所
-
-
Quebec
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Québec、Quebec、カナダ、G1V 0A6
- 募集
- INAF, Université Laval
-
コンタクト：
- Julie Marois, M.Sc.
- 電話番号：1-418-656-5258
- メール：julie.marois@fsaa.ulaval.ca
-
主任研究者：
- André Marette, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dairy yogurt
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Dairy yogurt: two serving daily
|
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アクティブコンパレータ：Plant-based yogurt
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Plant based yogurt: two servings daily
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プラセボコンパレーター：No yogurt
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No yogurt: zero serving yogurt
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in bone health
時間枠：At baseline and at the end of the intervention (12 weeks)
|
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
時間枠：At baseline and at the end of the intrevention (12 weeks)
|
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
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in body weight
時間枠：At baseline and at the end of the intervention (12 weeks)
|
At baseline and at the end of the intervention (12 weeks)
|
|
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Change in anthropometric measures
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of body mass index (BMI) using weight and height.
These two measurements will be combined to calculate BMI in kg/m2
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in anthropometric measure
時間枠：At baseline and at the end of the intervention (12 weeks)
|
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
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of changes in lean mass, fat mass and visceral fat mass (all in grams) using body composition by Dual X-ray Absorptiometry scan
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in skeletal muscle health
時間枠：At baseline and at the end of the intervention (12 weeks)
|
muscle strength using handgrip strength tool (kg)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in skeletal muscle health
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of physical performance using Timed Up and go Test
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in skeletal muscle health
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of functionnal capicity using 6-minute walk test)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Resting Metabolic Rate (RMR)
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Change in RMR using Calorimetry Device
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Appetite and Satiety
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of leptin and ghrelin (both with same units of measurement)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Appetite and Satiety
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of appetite and satiety using visual analog scale
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in Eating behaviors
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of eating behaviors using Food Cravings Questionnaire (FCQ-T)
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in glycemia
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of fasting glucose concentration
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in insulinemia
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of fasting insulin concentration
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in lipid profile
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of triglycerides, LDL-cholesterol and HDL-cholesterol
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in blood pressure
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of systolic and diastolic blood pressure
|
At baseline and at the end of the intervention (12 weeks)
|
|
Change in chronic inflammation
時間枠：At baseline and at the end of the intervention (12 weeks)
|
Assessment of plasma high sensitive C-Reactive Protein (hs-CRP) concentrations
|
At baseline and at the end of the intervention (12 weeks)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年11月1日
一次修了 (推定)
2026年6月30日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月11日
QC基準を満たした最後の更新が送信されました
2026年5月5日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PROYO 2022-108
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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