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

NCT06845995 | Completed

• 1 other identifier: IRB2021-1078
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (27)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline and at 3 months

Study Arms (2)

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.

Dietary Supplement: Synbiotic supplement

Interventions

Synbiotic supplement DIETARY_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

Intervention Group-Receive Synbiotic Supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Shannon Galyean

Lubbock, Texas, 79401, United States

Location

Related Publications (23)

• 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.

  PMID: 18495461 BACKGROUND

• Aron-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.

  PMID: 29899081 BACKGROUND

• Delzenne 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.

  PMID: 21826100 BACKGROUND

• Delzenne 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.

  PMID: 21995448 BACKGROUND

• Fernandes 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.

  PMID: 25909598 BACKGROUND

• Gill 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.

  PMID: 16741115 BACKGROUND

• Graessler 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.

  PMID: 23032991 BACKGROUND

• Kong 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.

  PMID: 23719559 BACKGROUND

• LeBlanc 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.

  PMID: 22940212 BACKGROUND

• Mondul 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.

  PMID: 27339624 BACKGROUND

• Ogden 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.

  PMID: 24570244 BACKGROUND

• Peat 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.

  PMID: 26426680 BACKGROUND

• Rossi 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.

  PMID: 22254078 BACKGROUND

• Rowland 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.

  PMID: 28393285 BACKGROUND

• Woodard 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.

  PMID: 19381735 BACKGROUND

• Berry D, Hypponen E. Determinants of vitamin D status: focus on genetic variations. Curr Opin Nephrol Hypertens. 2011 Jul;20(4):331-6. doi: 10.1097/MNH.0b013e328346d6ba.

  PMID: 21654390 BACKGROUND

• Crovesy L, Rosado EL. Interaction between genes involved in energy intake regulation and diet in obesity. Nutrition. 2019 Nov-Dec;67-68:110547. doi: 10.1016/j.nut.2019.06.027. Epub 2019 Jul 2.

  PMID: 31472367 BACKGROUND

• Davies NM, Holmes MV, Davey Smith G. Reading Mendelian randomisation studies: a guide, glossary, and checklist for clinicians. BMJ. 2018 Jul 12;362:k601. doi: 10.1136/bmj.k601.

  PMID: 30002074 BACKGROUND

• English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018 Mar;14(3):259-263. doi: 10.1016/j.soard.2017.12.013. Epub 2017 Dec 16.

  PMID: 29370995 BACKGROUND

• Fallaize R, Macready AL, Butler LT, Ellis JA, Lovegrove JA. An insight into the public acceptance of nutrigenomic-based personalised nutrition. Nutr Res Rev. 2013 Jun;26(1):39-48. doi: 10.1017/S0954422413000024. Epub 2013 Apr 8.

  PMID: 23561449 BACKGROUND

• Gemmel K, Santry HP, Prachand VN, Alverdy JC. Vitamin D deficiency in preoperative bariatric surgery patients. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):54-9. doi: 10.1016/j.soard.2008.07.008. Epub 2008 Jul 24.

  PMID: 18848507 BACKGROUND

• Moize VL, Pi-Sunyer X, Mochari H, Vidal J. Nutritional pyramid for post-gastric bypass patients. Obes Surg. 2010 Aug;20(8):1133-41. doi: 10.1007/s11695-010-0160-9.

  PMID: 20401543 BACKGROUND

• Trovato GM. Behavior, nutrition and lifestyle in a comprehensive health and disease paradigm: skills and knowledge for a predictive, preventive and personalized medicine. EPMA J. 2012 Mar 22;3(1):8. doi: 10.1007/s13167-012-0141-2.

  PMID: 22738244 BACKGROUND

Study Officials

• Shannon Galyean

  Texas Tech Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if they are taking synbiotic or placebo pill once daily.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: February 25, 2025
• Study Start: May 21, 2023
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: February 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: after publication
• Access Criteria: IPD will be available upon request of corresponding author.

Locations

US (1)