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MicrobiomeRAMPNCT03690999

The RAMP Study - Rejuvenation of the Aging Microbiota With Prebiotics

A study testing Prebiotic supplement in people with Microbiome and Immune Function, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Microbiome, Immune Function, Inflammation
What is being tested?
Prebiotic supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
1 siteUnited States
Study dates
14 Mar 2019to 14 Dec 2020
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 30Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Impact of a Prebiotic Supplement on Microbiome, Immune System, and Metabolic Status of Older Adults

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.

Read the 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.

Being tested
Placebo, Prebiotic supplement
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Placebo product

  • Prebiotic supplementDietary supplement

    Prebiotic supplement

Study groups in NCT03690999
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorPlacebo product
Receives: Dietary Supplement: Placebo
Prebiotic Supplement, low doseExperimentalNot described
Receives: Dietary Supplement: Prebiotic supplement
Prebiotic Supplement, high doseExperimentalNot described
Receives: Dietary Supplement: Prebiotic supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 weeks

Secondary outcomes (10)

  1. Microbiota composition

    Change from baseline in alpha diversity at 6 weeks. We will be using number of observed sequence variants ("species") determined by standard 16S rRNA amplicon sequencing (V3-V5 region followed by DADA2 to define error-corrected sequence variants) as our primary metric of alpha diversity. Higher alpha diversity is better. The units are the # of sequence variants.

    Measured: Baseline and 6 weeks

  2. Microbiota function

    Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 6 weeks.

    Measured: Baseline and 6 weeks

  3. Weight

    Change from Baseline in weight at 6 weeks.

    Measured: Baseline and 6 weeks

  4. Waist Circumference

    Change from Baseline in waist circumference at 6 weeks.

    Measured: Baseline and 6 weeks

  5. Blood pressure

    Change from Baseline in blood pressure at 6 weeks.

    Measured: Baseline and 6 weeks

  6. Total Cholesterol

    Change from Baseline in total cholesterol at 6 weeks.

    Measured: Baseline and 6 weeks

  7. Triglycerides

    Change from Baseline in triglycerides at 6 weeks.

    Measured: Baseline and 6 weeks

  8. HDL-cholesterol

    Change from Baseline in HDL-cholesterol at 6 weeks.

    Measured: Baseline and 6 weeks

  9. Fasting Glucose

    Change from Baseline in fasting glucose at 6 weeks.

    Measured: Baseline and 6 weeks

  10. Fasting Insulin

    Change from Baseline in fasting insulin at 6 weeks.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2018
  2. Study start14 Mar 2019
  3. Primary completion13 Nov 2020
  4. Study completion14 Dec 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690999
Sponsor's protocol ID
47252
Acronym
RAMP
Status last verified
Feb 2023
First submitted
17 Sep 2018
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40738103

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic supplement in people with Microbiome and Immune Function, run by Stanford 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 30 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 17 Feb 2023. 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. Some participants in this study may receive a placebo. 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?

Immune status and function (time frame: Baseline and 6 weeks). 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 NCT03690999, which also lists 1 linked publication.

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 17 Feb 2023.

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