The Effects of a Synbiotic Supplement on Metabolic & Cognitive Outcomes and Vitamin D Receptor Variants on Bone Health Among Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Texas Tech University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Fecal samples (bacterial diversity)
Study Overview
Brief Summary
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants will not know if they are taking synbiotic or placebo pill once daily.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Control Group
Daily placebo: The placebo will be one capsule daily and consists of Microcrystalline Cellulose, Hypromellose, Titanium Dioxide.
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.
Intervention: Synbiotic supplement (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported