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

NCT05350579 | Terminated

• 1 other identifier: 18-095-MAN
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis; Inflammation

Outcome Measures

Primary Outcomes (2)

• Concentration of Bone Formation Markers in Serum

  To evaluate bone health at baseline and at study completion, bone formation markers, pro-collagen I alpha 1 (P1NP) pg/mL and osteocalcin (OC) pg/mL will be measured in serum using ELISA kits.

  8 weeks

• Concentration of Bone Resorption Marker in Serum

  To evaluate bone health at baseline and at study completion, bone resorption marker, tartrate-resistant acid phosphatase subunit 5b (TRAP5b) in units/L will be measured in serum using ELISA kits.

  8 weeks

Secondary Outcomes (5)

• Profiling of the Gut Microbiota via Feces

  12 weeks

• Concentration of Fecal Short-Chain Fatty Acids

  12 weeks

• Concentration of C-Reactive Protein as a Marker of Systemic Inflammation in Serum

  8 weeks

• Aggregate Inflammatory Cytokine Score (ICS)

  8 weeks

• Concentration of Intestinal Integrity Biomarkers in Plasma

  8 weeks

Study Arms (2)

Yogurt Intervention

EXPERIMENTAL

Participants assigned to the yogurt group were provided with a biweekly supply of yogurt at every other visit and were directed to consume one serving daily (5-ounce, 141 grams) and to store the remaining yogurt at 40˚ F or lower until consumed. Additionally, all participants were instructed to keep a log of any yogurt consumption time and changes to bowel health. The ingredients of the yogurt include Pasteurized Grade A Milk, Cane Sugar, Yogurt Cultures (L. bulgaricus, S. thermophilus), and Vanilla Extract. The intervention meets the Codex Alimentarius definition of yogurt. In addition, the yogurt lacked preservatives, added fruit or pectin, was not enriched with added prebiotics or probiotics.

Other: Yogurt Intervention

Diet Control

NO INTERVENTION

The control group was asked to abstain from yogurt consumption. Diet (including yogurt consumption) was monitored by weekly 24-hour dietary recalls throughout the study period.

Interventions

Yogurt Intervention OTHER

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.

Yogurt Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported Caribbean Latino descent
• at least 50 years of age

You may not qualify if:

• usual yogurt intake (\> 2 servings per week)
• use of antibiotics in the past 6 months
• regular weekly laxative use
• self-reported osteoporosis
• history of osteoporosis-related fracture
• self-reported diagnosis of cancer
• self-reported diagnosis of gastrointestinal diseases (Crohn's disease, ulcerative colitis, Clostridium difficile infection)
• history of gastrointestinal alteration procedures (appendectomy, gastric bypass surgery)
• use of osteoporosis drugs
• use of steroids
• use of chemotherapeutic agents

Sponsors & Collaborators

• University of Massachusetts, Lowell: lead
• University of Massachusetts, Worcester: collaborator
• The Lawrence Senior Center: collaborator
• Danone Institute International: collaborator
• American Society for Nutrition: collaborator
• The International Osteoporosis Foundation: collaborator

Study Sites (1)

Lawrence Senior Center

Lawrence, Massachusetts, 01840, United States

Location

Related Publications (1)

• McGrail L, Vargas-Robles D, Correa MR, Merrill LC, Noel SE, Velez M, Maldonado-Contreras A, Mangano KM. Daily yogurt consumption does not affect bone turnover markers in men and postmenopausal women of Caribbean Latino descent: a randomized controlled trial. BMC Nutr. 2024 Jan 11;10(1):12. doi: 10.1186/s40795-023-00800-2.

  PMID: 38212847 DERIVED

MeSH Terms

Conditions

Osteoporosis; Inflammation

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kelsey M Mangano, PhD

  University of Massachusetts, Lowell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 28, 2022
• Study Start: March 28, 2019
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)