Effects of a Synbiotic Supplement on Metabolic & Cognitive Outcomes Among Older Adults

February 19, 2025 updated by: Texas Tech University

The Effects of a Synbiotic Supplement on Metabolic & Cognitive Outcomes and Vitamin D Receptor Variants on Bone Health Among Adults

The goal of this clinical trial is to investigate the effects of a prebiotic and probiotic supplement on metabolic, cognitive, and muscle health in older adults.

Participants in the study will be older adults who will receive a prebiotic and probiotic supplement containing different strains of Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus rhamnosus, and Lactobacillus gasseri. The study will collect data at baseline and after 3 months of supplementation to compare the effects on metabolic, cognitive, and muscle health. Additionally, genetic variants associated with vitamin D deficiency and muscle phenotypes will be identified in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective one of this research is to determine if there are significant differences in metabolic and muscle health including anthropometrics, biochemical, and muscle quality indices using a prebiotic and probiotic supplement containing different strains of Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus rhamnosus, and Lactobacillus gasseri in older adults.

There are many physiological changes that occur with aging, which include alterations in the gut microbiota. Gut dysbiosis has also been associated with aging as well as immunity and metabolic alterations such as cardiovascular disease, low-grade inflammation and frailty (Badal et al., 2020). Some studies have shown that probiotics can be a potential therapy to restore the balance of healthy human intestinal function and gut bacterial composition of the gut microbiota because they contain microorganisms naturally found in the human microfiora (Lee et al., 2020). The gut microbiota and its associations with aging are related to clinical and metabolic improvements (Badal et al., 2020). Probiotics and functional foods may have a beneficial effect on the gut by increasing the levels of bifidobacteria or modifying subpopulations of lactobacilli (Ale & Binetti, 2021). The gut microbiota is very important to human metabolism because of its' contribution of enzymes that are not encoded by the human genome, for example, the breakdown of polysaccharides, polyphenols, and synthesis of vitamins (Rowland et al., 2018). It is important to identify the effect that environmental factors, dietary factors (pre and probiotics, etc.), and their combined effect on metabolic and muscle health such as body composition, blood parameters, and muscle quality. Literature shows the benefits of synbiotic (pre and probiotic formula) on several cardiovascular risk factors including lipid and glycemic metabolic parameters in elderly patients (Cicero et al.,2021). However, the optimal timing for supplementation, duration of treatment, as well as the type and dose of the prebiotic and synbiotic to be used needs to be contemplated (Ale & Binetti., 2021).

• Objective two will be to identify variant genes associated with vitamin D deficiency and muscle phenotypes among older adults. Genetic variants for vitamin D deficiency have not been thoroughly studied in older adults. Significant associations have been identified between VDR polymorphism and muscle performance phenotypes although results were conflicting (Pratt et al., 2020). Several allelic variations have been described in the VDR gene, including restriction fragment length polymorphisms, such as Fok1 (C/T) (rs10735810/rs2228570) and Bsm1 (A/G) (rs1544410) (Berry & Hypponen, 2011). This will study the effect of genetic variations on the nutritional requirements of an individual and can provide some prediction to help with prevention as well as contribute to personalized dietary management (Crovesy & Rosado, 2019). It could also lead to improved clarification on the association between vitamin D status and patient outcomes following bariatric surgery (Berry & Hypponen, 2011; Davies et al., 2018).

Objective three will be to identify if there are significant differences in cognitive health including memory, attention, executive functioning, biochemical, and psychomotor skills indices using a prebiotic and probiotic supplement containing different strains of Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus rhamnosus, and Lactobacillus gasseri in older adults. There are many cognitive changes that occur with aging. Probiotics have been proposed to improve cognitive impairment via the gut-brain axis in patients and experimental animal models (Kim et al, 2021), (Asaoka et al, 2022), (Handajani et al, 2022). However, the beneficial role of synbiotics in brain function of healthy older adults remains unclear (Kim et al, 2021).

Objective one:

Based on 0- to 3-month data collection for baseline and post-intervention physiological outcomes: • What are the differences between basal and 3-month post synbiotic supplementation with regard to the following measurements (biological markers, gut QOL, genetic markers, anthropometric variables).

Based on 3-month supplementation of synbiotics from baseline to 3 months:

Does synbiotic supplementation for 3 months (from baseline to 3rd month) improve gut bacterial functions and gut quality of life in older adults compared to no supplementation?

  • If participant report improvement in gut quality of life, are these associated with other physiological indicators of metabolic health (i.e. biological markers, genetic markers, anthropometric variables)?
  • Is there an association between improved gut microbiota and gut quality of life and physiological indicators of metabolic health?
  • Are any associations observed between improved gut microbiota and biological markers, guts QOL, genetic markers, anthropometric variables?

Objective two:

  • What is the prevalence of Vitamin D Receptor (DR) genetic variants in this population?
  • Are VDR genetic variants associated with vitamin D deficiency and muscle quality (measured by serum levels, body composition and grip strength)?

Objective three:

Based on 0- to 3-month data collection for baseline and post-intervention physiological outcomes:

What are the differences between basal and 3-month post synbiotic supplementation with regard to the following measurements (biological markers, cognitive function tests, and psychomotor skills)?

Based on 3-month supplementation of synbiotics from baseline to 3 months:

If participant report improvement in gut quality of life, are these associated with other indicators of cognitive health (i.e. biological markers, cognitive function tests, and psychomotor skills)?

Is there an association between improved gut microbiota and gut quality of life and indicators of cognitive health?

Are any associations observed between improved gut microbiota and biological markers, cognitive function tests, and psychomotor skills?

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79401
        • Shannon Galyean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion screening:

  • ≥65 years of age
  • Male and female
  • Physically active as defined by participating in activity beyond baseline activities of daily living (dressing, bathing, toileting, continence, eating, and transferring).

Exclusion screening:

  • <65 years of age
  • Intake of nicotine, alcohol, and/or drugs such as amphetamines, cocaine, marijuana, and opiates
  • Intake of antibiotics or probiotics in the past 3 months
  • Intake of medications that might interfere with the study outcomes (e.g. bisphosphonates, steroids, calcitonin, thiazides, glucocorticoids)
  • Subjects with hypogonadism, hyperparathyroidism or acute or chronic inflammatory diseases including inflammatory bowel disease, infectious diseases, viral infection, cancer, transplant, renal disorders
  • Limited mobility
  • Self-reported cognitive dysfunction
  • Have heart pacemaker
  • People with Type 1 diabetes and Type 2 diabetes taking insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Daily placebo: The placebo will be one capsule daily and consists of Microcrystalline Cellulose, Hypromellose, Titanium Dioxide.
Experimental: Intervention Group-Receive Synbiotic Supplement
Daily synbiotic supplement: The synbiotic supplement (contains both probiotic and prebiotic) that will be used in this study is commercially available; Celebrate Balance. The probiotic will be one capsule daily and consists of lactobacillus acidophilus, Bifidobacterium longum, lactobacillus rhamnosus, and lactobacillus gasser at 28,5 Billion Colony-forming units (CFUs) at manufacture / 15 billion CFUs guaranteed at expiration.
Dietary supplement: Synbiotic supplement
Daily synbiotic supplement: The synbiotic supplement (contains both probiotic and prebiotic) that will be used in this study is commercially available; Celebrate Balance. The probiotic will be one capsule daily and consists of lactobacillus acidophilus, Bifidobacterium longum, lactobacillus rhamnosus, and lactobacillus gasser at 28,5 Billion CFUs at manufacture / 15 billion CFUs guaranteed at expiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal samples (bacterial diversity)
Time Frame: Baseline and at 3 months
To assess the differences in gut bacteria diversity after 3 months of supplementation with the synbiotic supplement using the 16S rRNA sequencing analysis method.
Baseline and at 3 months
Fecal samples (transcriptomics)
Time Frame: Baseline and at 3 months
To assess the gene expression patterns of microorganisms within the gut, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will utilize the NovaSeq 6000 sequencing system method.
Baseline and at 3 months
Serum Glucagon-like peptide-1 (GLP-1)
Time Frame: Baseline and at 3 months
To evaluate the levels of appetite hormones, including Glucagon-like peptide-1 (GLP-1) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Interleukin-1beta (IL-1beta)
Time Frame: Baseline and at 3 months
To evaluate the levels of cytokines, including Interleukin-1beta (IL-1beta) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Noradrenaline/Norepinephrine
Time Frame: Baseline and at 3 months
To evaluate the serum levels of Noradrenaline/Norepinephrine both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed with ELISA kits.
Baseline and at 3 months
Serum Vitamin D
Time Frame: Baseline and at 3 months
To evaluate the levels of vitamin D, within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed at a clinical pathology laboratory.
Baseline and at 3 months
Serum Total Cholesterol
Time Frame: Baseline and at 3 months
To evaluate the level of total cholesterol within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed at a clinical pathology laboratory.
Baseline and at 3 months
gut quality of life questionnaire
Time Frame: Baseline and at 3 months
To evaluate the quality of life levels related to gut condition, both at baseline and after three months of supplementation with the synbiotic supplement, the investigators will use the Gut Quality of Life Questionnaire. This is an 11-item questionnaire regarding GI symptoms with a score range of 0 - 44. The lower the score the more negative GI symptoms.
Baseline and at 3 months
Serum Peptide YY (PYY)
Time Frame: Baseline and at 3 months
To evaluate the levels of appetite hormones, including Peptide YY (PYY) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Ghrelin
Time Frame: Baseline and at 3 months
To evaluate the levels of appetite hormones, including ghrelin within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Leptin
Time Frame: Baseline and at 3 months
To evaluate the levels of appetite hormones, including leptin within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Insulin
Time Frame: Baseline and at 3 months
To evaluate the levels of appetite hormones, including insulin within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Glucagon
Time Frame: Baseline and at 3 months
To evaluate the levels of appetite hormones, including glucagon within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Tumor Necrosis Factor Alpha (TNF-α)
Time Frame: Baseline and at 3 months
To evaluate the levels of cytokines, including Tumor Necrosis Factor Alpha (TNF-α) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Interferon gamma (IFNG or IFN-γ)
Time Frame: Baseline and at 3 months
To evaluate the levels of cytokines, including Interferon gamma (IFNG or IFN-γ) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Interleukin-6 (IL-6)
Time Frame: Baseline and at 3 months
To evaluate the levels of cytokines, including Interleukin-6 (IL-6) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigatorswill employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Interleukin-1 receptor (IL-1R)
Time Frame: Baseline and at 3 months
To evaluate the levels of cytokines, including interleukin-1 receptor (IL-1R) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Interleukin-10 (IL-10)
Time Frame: Baseline and at 3 months
To evaluate the levels of cytokines, including Interleukin-10 (IL-10) within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement, the investigators will employ the Multiplex 96-well plate assay method.
Baseline and at 3 months
Serum Dopamine
Time Frame: Baseline and at 3 months
To evaluate the serum levels of dopamine both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed with ELISA kits.
Baseline and at 3 months
Serum Serotonin
Time Frame: Baseline and at 3 months
To evaluate the serum levels of serotonin both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed with ELISA kits.
Baseline and at 3 months
Serum Brain-derived neurotrophic factor (BDNF)
Time Frame: Baseline and at 3 months
To evaluate the serum levels of Brain-derived neurotrophic factor (BDNF) both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed with ELISA kits.
Baseline and at 3 months
Serum Precursor proneurotrophin isoform of BDNF (pro-BDNF)
Time Frame: Baseline and at 3 months
To evaluate the serum levels of precursor proneurotrophin isoform of BDNF (pro-BDNF) both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed with ELISA kits.
Baseline and at 3 months
Serum Cortisol
Time Frame: Baseline and at 3 months
To evaluate the serum levels of Cortisol both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed with ELISA kits.
Baseline and at 3 months
Serum Insulin-like growth factor-1 (IGF-1)
Time Frame: Baseline and at 3 months
To evaluate the serum levels of Insulin-like growth factor-1 (IGF-1) both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed with ELISA kits.
Baseline and at 3 months
Serum LDL cholesterol
Time Frame: Baseline and at 3 months
To evaluate the levels of LDL cholesterol within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed at a clinical pathology laboratory.
Baseline and at 3 months
Serum Triglycerides
Time Frame: Baseline and at 3 months
To evaluate the levels of triglycerides within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed at a clinical pathology laboratory.
Baseline and at 3 months
Serum Glucose
Time Frame: Baseline and at 3 months
To evaluate the levels of glucose within the serum, both at baseline and after a three-month supplementation with a synbiotic supplement. These will be analyzed at a clinical pathology laboratory.
Baseline and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University

Investigators

  • Principal Investigator: Shannon Galyean, Texas Tech Nutritional Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2023

Primary Completion (Actual)

July 9, 2024

Study Completion (Actual)

July 9, 2024

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB2021-1078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available upon request of corresponding author.

IPD Sharing Time Frame

after publication

IPD Sharing Access Criteria

IPD will be available upon request of corresponding author.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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