The RAMP Study - Rejuvenation of the Aging Microbiota With Prebiotics

NCT ID: NCT03690999

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2020-12-14

Brief Summary

An individual's immune and metabolic status is coupled to consumed carbohydrates. Complex carbohydrates that are not digested by human enzymes may influence host biology by impacting microbiota composition and function, or act in a yet-unknown microbiota-independent manner. Prebiotics offer a promising safe route to influence host health, possibly via the microbiota. However, it remains largely unknown to what extent immune function and metabolism can be modulated by prebiotics.

Detailed Description

The objective of this study is to define the impact of a prebiotic supplement on microbiome, immune system, and metabolic status in older adults. This study will determine the degree to which a prebiotic supplement can 1) regulate immune status and function including reducing chronic, systemic inflammation as assessed by high dimensional immune profiling, 2) alter microbiota composition and function, 3) impact the microbiota metabolites-potential normalizers of metabolic and immune dysfunction, and 4) alter metabolic markers.

Conditions

Microbiome; Immune Function; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

Placebo product

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo product

Prebiotic Supplement, low dose

Group Type: EXPERIMENTAL

Prebiotic supplement

Intervention Type: DIETARY_SUPPLEMENT

Prebiotic supplement

Prebiotic Supplement, high dose

Group Type: EXPERIMENTAL

Prebiotic supplement

Intervention Type: DIETARY_SUPPLEMENT

Prebiotic supplement

Interventions

Placebo

Placebo product

Intervention Type: DIETARY_SUPPLEMENT

Prebiotic supplement

Prebiotic supplement

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 60 years old and older
• Otherwise, healthy subjects willing and able to provide blood as well as stool specimens
• Must be able to provide signed and dated informed consent and be willing to follow protocol

Exclusion Criteria

• Body Mass Index >= 40
• LDL-C > 190 mg/dL
• Systolic Blood Pressure >160 mmHg OR Diastolic Blood Pressure > 90 mmHg
• Use of any of the following drugs/supplements within the last 2 months:

• systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
• corticosteroids (intravenous, intramuscular, oral, nasal or inhaled)
• cytokines
• methotrexate or immunosuppressive cytotoxic agents
• metformin
• proton pump inhibitors (PPIs)
• Regular use of any of the following medications:

• regular dose aspirin (>81mg/day)
• opiate pain medication
• Use of large doses of commercial probiotics consumed (greater than or equal to 10-8 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
• Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Examples include flu or gastroenteritis. Defer sampling until subject recover.
• Chronic, clinically significant, unstable (unresolved, requiring on-going changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history. Type 2 diabetes, type 1 diabetes, and dialysis will be excluded.
• History of active uncontrolled gastrointestinal disorders or diseases including:

• inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
• irritable bowel syndrome (IBS) (moderate-severe);
• persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).
• History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
• Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
• Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or > 14 drinks/week.
• Positive test for HIV, HBV or HCV.
• Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.
• Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
• Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products.
• Any confirmed or suspected autoimmune disease. Examples include multiple sclerosis and Graves disease.
• Veganism.
• Dairy allergies.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Justin L. Sonnenburg

Associate Professor of Microbiology and Immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justin Sonnenburg, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

Carter MM, Demis D, Perelman D, St Onge M, Petlura C, Cunanan K, Mathi K, Maecker HT, Chow JM, Robinson JL, Sabag-Daigle A, Sonnenburg ED, Buck RH, Gardner CD, Sonnenburg JL. A human milk oligosaccharide alters the microbiome, circulating hormones, and metabolites in a randomized controlled trial of older adults. Cell Rep Med. 2025 Aug 19;6(8):102256. doi: 10.1016/j.xcrm.2025.102256. Epub 2025 Jul 29.

Reference Type: DERIVED

PMID: 40738103 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Related Links

https://med.stanford.edu/nutrition/research/completed-studies/RAMPStudy.html

Study description

Other Identifiers

47252

Identifier Type: -

Identifier Source: org_study_id