The RAMP Study - Rejuvenation of the Aging Microbiota With Prebiotics

NCT03690999 | Completed

• 1 other identifier: 47252
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiome; Immune Function; Inflammation

Outcome Measures

Primary Outcomes (1)

• Immune status and function

  Change from baseline in Cytokine Response Score (CRS) at 6 weeks. The CRS is a single composite measure of cell-type specific activation of signaling pathways from ex vivo cytokine stimulation of blood samples. This provides a measure of immune response capacity which may be an indicator of immune fitness. The CRS will be calculated as described in Shen-Orr et al, Cell Systems, 2016. The CRS is the sum of 15 age-associated normalized cytokine responses identified in Shen-Orr et. al: In CD8+ T cells: IFNα pSTAT1, pSTAT3, pSTAT5; IL-6 pSTAT1, pSTAT3, pSTAT5; IFNγ pSTAT1; IL-21 pSTAT1; In CD4+ T cells: IFNα pSTAT5; IL-6 pSTAT5; In B cells: IFNα pSTAT1; in monocytes: IL-10 pSTAT3; IFNγ pSTAT3; IFNα pSTAT3; IL-6 pSTAT3. Each feature is calculated as the fold change of the protein in the stimulated condition relative to its level in the unstimulated condition. That value is then normalized to the feature's range: normalized = (x - xmin)/xmax. The 15 normalized values are summed for the CRS.

  Baseline and 6 weeks

Secondary Outcomes (10)

• Microbiota composition

  Baseline and 6 weeks

• Microbiota function

  Baseline and 6 weeks

• Weight

  Baseline and 6 weeks

• Waist Circumference

  Baseline and 6 weeks

• Blood pressure

  Baseline and 6 weeks

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Placebo product

Dietary Supplement: Placebo

Prebiotic Supplement, low dose

EXPERIMENTAL

Dietary Supplement: Prebiotic supplement

Prebiotic Supplement, high dose

EXPERIMENTAL

Dietary Supplement: Prebiotic supplement

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo product

Placebo group

Prebiotic supplement DIETARY_SUPPLEMENT

Prebiotic supplement

Prebiotic Supplement, high dose; Prebiotic Supplement, low dose

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Abbott: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 40738103 DERIVED

Related Links

• Study description

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin Sonnenburg, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Microbiology and Immunology

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: October 1, 2018
• Study Start: March 14, 2019
• Primary Completion: November 13, 2020
• Study Completion: December 14, 2020
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)