Yogurt Supplementation to Alter Bone Biomarkers, the Gut Microbiota and Inflammation in Older Adults

NCT05350579 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-04-28

No results posted yet for this study

Summary

Caribbean Latino adults are a vulnerable population at risk for developing osteoporosis. In addition to lifestyle factors, such as dietary intake, the investigators hypothesize that a unhealthy gut microbial environment coupled with high inflammation contributes to the risk of developing osteoporosis. There has been little research conducted on mechanisms underpinning how a low-intensity dietary intervention, including supplementation with daily yogurt, can affect the gut health of Caribbean Latino adults. The study objectives are to: 1) determine whether daily yogurt supplementation reduces bone turnover (biomarkers of overall bone health) and inflammation compared to a control group that maintains their usual diet (void of yogurt); and 2) collect preliminary data on the effects of daily yogurt supplementation on the gut microbiome compared to diet control group.

Conditions

Interventions

OTHER

Yogurt Intervention

Participants will be asked to consume one serving of yogurt per day. Nutrient composition of yogurt provided to participants in the yogurt group: Nutrients per serving Serving Size: 141 g Energy (kcal) 170 Total Fat (g) 8 Total Carbohydrate (g) 16 Sugars (g) 15 Protein (g) 5 Sodium (mg) 85 Calcium (%) 15 Vitamin A (%) 4 Ingredients: Pasteurized Grade A Milk, Cane Sugar, Yogurt Cultures (S. thermophilus, L. bulgaricus), Vanilla Extract.

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    collaborator OTHER
  • The Lawrence Senior Center

    collaborator UNKNOWN
  • Danone Institute International

    collaborator OTHER
  • American Society for Nutrition

    collaborator OTHER
  • The International Osteoporosis Foundation

    collaborator OTHER
  • University of Massachusetts, Lowell

    lead OTHER

Principal Investigators

  • Kelsey M Mangano, PhD · University of Massachusetts, Lowell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350579 on ClinicalTrials.gov