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Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota (PROYO)

5. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

75

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Rekruttering
        • INAF, Université Laval
        • Ta kontakt med:
        • Hovedetterforsker:
          • André Marette, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dairy yogurt
Kosttilskudd: Dairy yogurt
Dairy yogurt: two serving daily
Aktiv komparator: Plant-based yogurt
Kosttilskudd: Plant based yogurt
Plant based yogurt: two servings daily
Placebo komparator: No yogurt
Kosttilskudd: No yogurt
No yogurt: zero serving yogurt

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in bone health
Tidsramme: At baseline and at the end of the intervention (12 weeks)
Assessment of bone mineral density using Dual X-ray Absorptiometry scan
At baseline and at the end of the intervention (12 weeks)
Change in bone health
Tidsramme: 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)
At baseline and at the end of the intrevention (12 weeks)
Change in gut microbiota
Tidsramme: At baseline and at the end of the intervention (12 weeks)
Assessment of global variation of the fecal microbiota
At baseline and at the end of the intervention (12 weeks)
Change in gut microbiota function
Tidsramme: At baseline and at the end of the intervention (12 weeks)
Assessment of short-chain fatty acid (SCFA) in feces
At baseline and at the end of the intervention (12 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in body weight
Tidsramme: At baseline and at the end of the intervention (12 weeks)
At baseline and at the end of the intervention (12 weeks)
Change in anthropometric measures
Tidsramme: 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
Tidsramme: At baseline and at the end of the intervention (12 weeks)
Assessment of waist circumference
At baseline and at the end of the intervention (12 weeks)
Change in body composition
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Laval University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2023

Primær fullføring (Antatt)

30. juni 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PROYO 2022-108

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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