Older AdultsNCT06845995
Effects of a Synbiotic Supplement on Metabolic & Cognitive Outcomes Among Older Adults
A study testing Synbiotic supplement in people with Older Adults and Bioelectrical Impedance, run by Texas Tech University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Bioelectrical Impedance, Appetite Hormones
- What is being tested?
- Synbiotic supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2023to 9 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥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).
Who cannot join
- <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
Show all 9Show fewer
- Self-reported cognitive dysfunction
- Have heart pacemaker
- People with Type 1 diabetes and Type 2 diabetes taking insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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?
- Conditions
- Older Adults, Bioelectrical Impedance, Appetite Hormones, Metabolic Health, Body Composition Measurement, Cognitive Health
- Being tested
- Synbiotic supplement
- Keywords
- Synbiotic supplement, Vitamin D receptor variants, Body composition, Bone health, Metabolic outcomes, Muscle strength, Appetite hormons, Cognitive health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic supplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Daily placebo: The placebo will be one capsule daily and consists of Microcrystalline Cellulose, Hypromellose, Titanium Dioxide. |
| Intervention Group-Receive Synbiotic Supplement | Experimental | 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. Receives: Dietary Supplement: Synbiotic supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal samples (bacterial diversity)
To assess the differences in gut bacteria diversity after 3 months of supplementation with the synbiotic supplement using the 16S rRNA sequencing analysis method.
Measured: Baseline and at 3 months
Fecal samples (transcriptomics)
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.
Measured: Baseline and at 3 months
Serum Glucagon-like peptide-1 (GLP-1)
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.
Measured: Baseline and at 3 months
Serum Interleukin-1beta (IL-1beta)
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.
Measured: Baseline and at 3 months
Serum Noradrenaline/Norepinephrine
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.
Measured: Baseline and at 3 months
Serum Vitamin D
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.
Measured: Baseline and at 3 months
Serum Total Cholesterol
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.
Measured: Baseline and at 3 months
gut quality of life questionnaire
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.
Measured: Baseline and at 3 months
Serum Peptide YY (PYY)
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.
Measured: Baseline and at 3 months
Serum Ghrelin
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.
Measured: Baseline and at 3 months
Serum Leptin
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.
Measured: Baseline and at 3 months
Serum Insulin
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.
Measured: Baseline and at 3 months
Serum Glucagon
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.
Measured: Baseline and at 3 months
Serum Tumor Necrosis Factor Alpha (TNF-α)
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.
Measured: Baseline and at 3 months
Serum Interferon gamma (IFNG or IFN-γ)
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.
Measured: Baseline and at 3 months
Serum Interleukin-6 (IL-6)
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.
Measured: Baseline and at 3 months
Serum Interleukin-1 receptor (IL-1R)
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.
Measured: Baseline and at 3 months
Serum Interleukin-10 (IL-10)
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.
Measured: Baseline and at 3 months
Serum Dopamine
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.
Measured: Baseline and at 3 months
Serum Serotonin
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.
Measured: Baseline and at 3 months
Serum Brain-derived neurotrophic factor (BDNF)
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.
Measured: Baseline and at 3 months
Serum Precursor proneurotrophin isoform of BDNF (pro-BDNF)
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.
Measured: Baseline and at 3 months
Serum Cortisol
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.
Measured: Baseline and at 3 months
Serum Insulin-like growth factor-1 (IGF-1)
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.
Measured: Baseline and at 3 months
Serum LDL cholesterol
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.
Measured: Baseline and at 3 months
Serum Triglycerides
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.
Measured: Baseline and at 3 months
Serum Glucose
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.
Measured: Baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start21 May 2023
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Potential subjects will be informed of the study through a study being conducted at Nutrition and Metabolic Health Initiative and at local exercise centers for senior adults and independent living communities by flyers and social media, which will give interested subjects contact information. Once interested subjects communicate with the research team, a research personnel will begin screening process by phone or in-person to see if subject qualifies based on inclusion/exclusion criteria. A research team member will schedule an in-person appointment for subjects that qualify for the study. The research team will ask the subjects to sign a consent form in-person prior to the baseline appointment, Once the consent is signed, random assignment to the study group and data collection will begin.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon Galyean, Principal investigator, Texas Tech Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845995
- Sponsor's protocol ID
- IRB2021-1078
- Status last verified
- Oct 2024
- First submitted
- 23 Aug 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon request of corresponding author.
Publications
Amit-Romach E, Uni Z, Cheled S, Berkovich Z, Reifen R. Bacterial population and innate immunity-related genes in rat gastrointestinal tract are altered by vitamin A-deficient diet. J Nutr Biochem. 2009 Jan;20(1):70-7. doi: 10.1016/j.jnutbio.2008.01.002. Epub 2008 May 20.
PubMed 18495461Aron-Wisnewsky J, Prifti E, Belda E, Ichou F, Kayser BD, Dao MC, Verger EO, Hedjazi L, Bouillot JL, Chevallier JM, Pons N, Le Chatelier E, Levenez F, Ehrlich SD, Dore J, Zucker JD, Clement K. Major microbiota dysbiosis in severe obesity: fate after bariatric surgery. Gut. 2019 Jan;68(1):70-82. doi: 10.1136/gutjnl-2018-316103. Epub 2018 Jun 13.
PubMed 29899081Delzenne NM, Neyrinck AM, Backhed F, Cani PD. Targeting gut microbiota in obesity: effects of prebiotics and probiotics. Nat Rev Endocrinol. 2011 Aug 9;7(11):639-46. doi: 10.1038/nrendo.2011.126.
PubMed 21826100Delzenne NM, Neyrinck AM, Cani PD. Modulation of the gut microbiota by nutrients with prebiotic properties: consequences for host health in the context of obesity and metabolic syndrome. Microb Cell Fact. 2011 Aug 30;10 Suppl 1(Suppl 1):S10. doi: 10.1186/1475-2859-10-S1-S10. Epub 2011 Aug 30.
PubMed 21995448Fernandes R, Beserra BT, Mocellin MC, Kuntz MG, da Rosa JS, de Miranda RC, Schreiber CS, Frode TS, Nunes EA, Trindade EB. Effects of Prebiotic and Synbiotic Supplementation on Inflammatory Markers and Anthropometric Indices After Roux-en-Y Gastric Bypass: A Randomized, Triple-blind, Placebo-controlled Pilot Study. J Clin Gastroenterol. 2016 Mar;50(3):208-17. doi: 10.1097/MCG.0000000000000328.
PubMed 25909598Gill SR, Pop M, Deboy RT, Eckburg PB, Turnbaugh PJ, Samuel BS, Gordon JI, Relman DA, Fraser-Liggett CM, Nelson KE. Metagenomic analysis of the human distal gut microbiome. Science. 2006 Jun 2;312(5778):1355-9. doi: 10.1126/science.1124234.
PubMed 16741115Graessler J, Qin Y, Zhong H, Zhang J, Licinio J, Wong ML, Xu A, Chavakis T, Bornstein AB, Ehrhart-Bornstein M, Lamounier-Zepter V, Lohmann T, Wolf T, Bornstein SR. Metagenomic sequencing of the human gut microbiome before and after bariatric surgery in obese patients with type 2 diabetes: correlation with inflammatory and metabolic parameters. Pharmacogenomics J. 2013 Dec;13(6):514-22. doi: 10.1038/tpj.2012.43. Epub 2012 Oct 2.
PubMed 23032991Kong LC, Tap J, Aron-Wisnewsky J, Pelloux V, Basdevant A, Bouillot JL, Zucker JD, Dore J, Clement K. Gut microbiota after gastric bypass in human obesity: increased richness and associations of bacterial genera with adipose tissue genes. Am J Clin Nutr. 2013 Jul;98(1):16-24. doi: 10.3945/ajcn.113.058743. Epub 2013 May 29.
PubMed 23719559LeBlanc JG, Milani C, de Giori GS, Sesma F, van Sinderen D, Ventura M. Bacteria as vitamin suppliers to their host: a gut microbiota perspective. Curr Opin Biotechnol. 2013 Apr;24(2):160-8. doi: 10.1016/j.copbio.2012.08.005. Epub 2012 Aug 30.
PubMed 22940212Mondul AM, Weinstein SJ, Albanes D. Vitamins, metabolomics, and prostate cancer. World J Urol. 2017 Jun;35(6):883-893. doi: 10.1007/s00345-016-1878-3. Epub 2016 Jun 23.
PubMed 27339624Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Peat CM, Kleiman SC, Bulik CM, Carroll IM. The Intestinal Microbiome in Bariatric Surgery Patients. Eur Eat Disord Rev. 2015 Nov;23(6):496-503. doi: 10.1002/erv.2400. Epub 2015 Oct 1.
PubMed 26426680Rossi M, Amaretti A, Raimondi S. Folate production by probiotic bacteria. Nutrients. 2011 Jan;3(1):118-34. doi: 10.3390/nu3010118. Epub 2011 Jan 18.
PubMed 22254078Rowland I, Gibson G, Heinken A, Scott K, Swann J, Thiele I, Tuohy K. Gut microbiota functions: metabolism of nutrients and other food components. Eur J Nutr. 2018 Feb;57(1):1-24. doi: 10.1007/s00394-017-1445-8. Epub 2017 Apr 9.
PubMed 28393285Woodard GA, Encarnacion B, Downey JR, Peraza J, Chong K, Hernandez-Boussard T, Morton JM. Probiotics improve outcomes after Roux-en-Y gastric bypass surgery: a prospective randomized trial. J Gastrointest Surg. 2009 Jul;13(7):1198-204. doi: 10.1007/s11605-009-0891-x. Epub 2009 Apr 18.
PubMed 19381735
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Synbiotic Supplement on Metabolic & Cognitive Outcomes and Vitamin D Receptor Variants on Bone Health Among Adults
- ClinicalTrials.gov ID
- NCT06845995
- Acronym / sponsor ID
- IRB2021-1078
- Conditions
- Older Adults, Bioelectrical Impedance, Appetite Hormones, Metabolic Health, Body Composition Measurement, Cognitive Health
- Keywords
- Synbiotic supplement, Vitamin D receptor variants, Body composition, Bone health, Metabolic outcomes, Muscle strength, Appetite hormons, Cognitive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 21 May 2023 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Potential subjects will be informed of the study through a study being conducted at Nutrition and Metabolic Health Initiative and at local exercise centers for senior adults and independent living communities by flyers and social media, which will give interested subjects contact information. Once interested subjects communicate with the research team, a research personnel will begin screening process by phone or in-person to see if subject qualifies based on inclusion/exclusion criteria. A research team member will schedule an in-person appointment for subjects that qualify for the study. The research team will ask the subjects to sign a consent form in-person prior to the baseline appointment, Once the consent is signed, random assignment to the study group and data collection will begin.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Daily placebo: The placebo will be one capsule daily and consists of Microcrystalline Cellulose, Hypromellose, Titanium Dioxide. |
| Intervention Group-Receive Synbiotic Supplement | Experimental | Dietary Supplement: Synbiotic supplementDaily 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥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).
Key exclusion criteria (9 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic supplementDaily 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 | Dietary supplement | Intervention Group-Receive Synbiotic Supplement |
Primary outcome
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.
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 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 18495461Amit-Romach E, Uni Z, Cheled S, Berkovich Z, Reifen R. Bacterial population and innate immunity-related genes in rat gastrointestinal tract are altered by vitamin A-deficient diet. J Nutr Biochem. 2009 Jan;20(1):70-7. doi: 10.1016/j.jnutbio.2008.01.002. Epub 2008 May 20.
- Background: PubMed 29899081Aron-Wisnewsky J, Prifti E, Belda E, Ichou F, Kayser BD, Dao MC, Verger EO, Hedjazi L, Bouillot JL, Chevallier JM, Pons N, Le Chatelier E, Levenez F, Ehrlich SD, Dore J, Zucker JD, Clement K. Major microbiota dysbiosis in severe obesity: fate after bariatric surgery. Gut. 2019 Jan;68(1):70-82. doi: 10.1136/gutjnl-2018-316103. Epub 2018 Jun 13.
- Background: PubMed 21826100Delzenne NM, Neyrinck AM, Backhed F, Cani PD. Targeting gut microbiota in obesity: effects of prebiotics and probiotics. Nat Rev Endocrinol. 2011 Aug 9;7(11):639-46. doi: 10.1038/nrendo.2011.126.
- Background: PubMed 21995448Delzenne NM, Neyrinck AM, Cani PD. Modulation of the gut microbiota by nutrients with prebiotic properties: consequences for host health in the context of obesity and metabolic syndrome. Microb Cell Fact. 2011 Aug 30;10 Suppl 1(Suppl 1):S10. doi: 10.1186/1475-2859-10-S1-S10. Epub 2011 Aug 30.
- Background: PubMed 25909598Fernandes R, Beserra BT, Mocellin MC, Kuntz MG, da Rosa JS, de Miranda RC, Schreiber CS, Frode TS, Nunes EA, Trindade EB. Effects of Prebiotic and Synbiotic Supplementation on Inflammatory Markers and Anthropometric Indices After Roux-en-Y Gastric Bypass: A Randomized, Triple-blind, Placebo-controlled Pilot Study. J Clin Gastroenterol. 2016 Mar;50(3):208-17. doi: 10.1097/MCG.0000000000000328.
- Background: PubMed 16741115Gill SR, Pop M, Deboy RT, Eckburg PB, Turnbaugh PJ, Samuel BS, Gordon JI, Relman DA, Fraser-Liggett CM, Nelson KE. Metagenomic analysis of the human distal gut microbiome. Science. 2006 Jun 2;312(5778):1355-9. doi: 10.1126/science.1124234.
- Background: PubMed 23032991Graessler J, Qin Y, Zhong H, Zhang J, Licinio J, Wong ML, Xu A, Chavakis T, Bornstein AB, Ehrhart-Bornstein M, Lamounier-Zepter V, Lohmann T, Wolf T, Bornstein SR. Metagenomic sequencing of the human gut microbiome before and after bariatric surgery in obese patients with type 2 diabetes: correlation with inflammatory and metabolic parameters. Pharmacogenomics J. 2013 Dec;13(6):514-22. doi: 10.1038/tpj.2012.43. Epub 2012 Oct 2.
- Background: PubMed 23719559Kong LC, Tap J, Aron-Wisnewsky J, Pelloux V, Basdevant A, Bouillot JL, Zucker JD, Dore J, Clement K. Gut microbiota after gastric bypass in human obesity: increased richness and associations of bacterial genera with adipose tissue genes. Am J Clin Nutr. 2013 Jul;98(1):16-24. doi: 10.3945/ajcn.113.058743. Epub 2013 May 29.
- Background: PubMed 22940212LeBlanc JG, Milani C, de Giori GS, Sesma F, van Sinderen D, Ventura M. Bacteria as vitamin suppliers to their host: a gut microbiota perspective. Curr Opin Biotechnol. 2013 Apr;24(2):160-8. doi: 10.1016/j.copbio.2012.08.005. Epub 2012 Aug 30.
- Background: PubMed 27339624Mondul AM, Weinstein SJ, Albanes D. Vitamins, metabolomics, and prostate cancer. World J Urol. 2017 Jun;35(6):883-893. doi: 10.1007/s00345-016-1878-3. Epub 2016 Jun 23.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Background: PubMed 26426680Peat CM, Kleiman SC, Bulik CM, Carroll IM. The Intestinal Microbiome in Bariatric Surgery Patients. Eur Eat Disord Rev. 2015 Nov;23(6):496-503. doi: 10.1002/erv.2400. Epub 2015 Oct 1.
- Individual participant dataSharing planned: Yes. IPD will be available upon request of corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Galyean principal investigator
Texas Tech Nutritional Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic supplement in people with Older Adults and Bioelectrical Impedance, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal samples (bacterial diversity) (time frame: Baseline and at 3 months). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06845995, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.