Stanford, California 94305


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

47252


NCT ID:

NCT03690999


Secondary ID:


Study Acronym:

RAMP


Brief Title:

The RAMP Study - Rejuvenation of the Aging Microbiota With Prebiotics


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Justin Sonnenburg, PhD
Principal Investigator
Stanford University
Primary Contact:Diane Demis, BS
650-724-8310
ddemis@stanford.edu
Backup Contact:Jennifer Robinson, PhD
650-736-857
jlmorris@stanford.edu

Study Dates

Start Date:March 14, 2019
Completion Date:March 2020
Completion Type:Anticipated
Primary Completion Date:March 2020
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 2, 2019
First Received Date:September 17, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Fasting Insulin
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in fasting insulin at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Fasting Glucose
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in fasting glucose at 6 weeks.
Outcome Type:Secondary Outcome
Measure:HDL-cholesterol
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in HDL-cholesterol at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Triglycerides
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in triglycerides at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Total Cholesterol
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in total cholesterol at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Blood pressure
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in blood pressure at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Waist Circumference
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in waist circumference at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Weight
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from Baseline in weight at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Microbiota function
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 6 weeks.
Outcome Type:Secondary Outcome
Measure:Microbiota composition
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description: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 p
Outcome Type:Primary Outcome
Measure:Immune status and function
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description: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 c

Study Interventions

Intervention Type:Dietary Supplement
Name:Placebo
Description:Placebo product
Arm Name:Placebo group
Intervention Type:Dietary Supplement
Name:Prebiotic supplement
Description:Prebiotic supplement
Arm Name:Prebiotic Supplement, low dose

Study Arms

Study Arm Type:Experimental
Arm Name:Prebiotic Supplement, high dose
Study Arm Type:Experimental
Arm Name:Prebiotic Supplement, low dose
Study Arm Type:Placebo Comparator
Arm Name:Placebo group
Description:Placebo product

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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