Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD

Springfield College

Status: Unknown

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: Exercise; Dietary Supplement: Resistant starch; Behavioral: Starch

Study type: Interventional

Funder types: Other

Identifiers

NCT03689569

Prebiotic study

Details and patient eligibility

About

The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.

Full description

The primary aim of the proposed study is to determine whether the consumption of a prebiotic supplement (resistant starch) coupled with moderate intensity endurance training over 16 weeks leads to reductions in key inflammatory markers in stage 3-4 predialysis CKD patients and whether this reduction is associated with favorable changes in vascular function and indicators of stress and emotional reactivity.

The investigators hypothesize that supplementation with the prebiotic (resistant starch) will lead to normalization of the microbiome of our sample of patients with chronic kidney disease (CKD) and reduce key markers of inflammation. Reductions in these biomarkers will be associated with favorable changes in cardiovascular variables along with indices of stress and emotional reactivity. Moderate intensity aerobic training will have an additive anti-inflammatory effect along with the consumption of the resistant starch.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),
• ages of 30-75 years old,
• Must be capable of complying with and following the study protocol(diet and exercise)
• Must be capable of independently giving informed consent

Exclusion criteria

• kidney transplant
• currently in a structured exercise program
• on antibiotic therapy within the last month
• On a probiotic or prebiotic supplement within the last month
• a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion
• HIV positive
• gastric by-pass surgery
• clostridium difficile
• marijuana user
• lupus
• rheumatoid arthritis
• Hepatitis C
• Post-traumatic stress disorder
• deep vein thrombosis
• pancreatitis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Exercise

Experimental group

Description:

Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training.

Treatment:

Behavioral: Exercise

Resistant Starch

Experimental group

Description:

Resistant starch only: Patients randomized to this group will receive 30 g of resistant starch daily for 16 weeks. They will not be given an exercise training

Treatment:

Dietary Supplement: Resistant starch

Exercise & Resistant Starch

Experimental group

Description:

Exercise \& resistant starch: Patients assigned to this group will do 16 weeks of personal training and they will be supplemented with 30 g of resistant starch daily for the 16 week period

Treatment:

Behavioral: Exercise

Dietary Supplement: Resistant starch

Starch

Placebo Comparator group

Description:

Corn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks

Treatment:

Behavioral: Starch