Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBall State University

About this trial

Based on prior research, the investigators are interested in whether an intervention targeting gut health (supplemental fiber for 9 weeks total) will improve vascular health in individuals with obesity. Additionally, the investigators are interested in if this response differs based on whether individuals with obesity have very few heart disease risk factors or several heart disease risk factors.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants are 18-55 years old.

Participants BMI is ≥30 kg/m2 - this BMI requirement is due to our research aims.

Participants have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.

Participants are not pregnant or expecting to become pregnant (females only). •Participants are not postmenopausal (females only).

Disqualifiers

Participants are not 18-55 years old.

Participants BMI is not ≥30 kg/m2 - this BMI requirement is due to our research aims.

Participants do not have either 0-1 or 2+ of the following risk factors outside of the normal reference ranges: blood pressure, blood sugar, triglycerides, and HDL-cholesterol.

Participants are pregnant or expecting to become pregnant (females only).

Trial design

Design model

Single group

Treatments tested in this trial

  • inulin

    Dietary supplement

    6g inulin from chicory root per day for one week and 12g inulin per day for eight weeks dissolved into cool or room temperature liquid

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Inulin SupplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum Soluble Cluster of Differentiation 14 (sCD14)

The investigators will measure fasting sCD14 at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.
2

Serum Lipopolysaccharide Binding Protein (LBP)

The investigators will measure fasting LBP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.
3

Serum C-Reactive Protein (CRP)

The investigators will measure fasting CRP at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.
4

Heart Rate Variability (HRV)

The investigators will measure HRV at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.

Secondary outcomes

1

Blood Pressure

The investigators will measure peripheral, central, and ambulatory blood pressure at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.
2

Glucose

The investigators will measure fasting glucose at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.
3

High-Density Lipoprotein Cholesterol (HDL-C)

The investigators will measure fasting HDL-C at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.
4

Triglycerides

The investigators will measure fasting triglycerides at each visit. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.

Other outcomes

1

Body Composition

The investigators will measure body composition using bioelectrical impedance and waist circumference at each visit, and dual-energy X-ray absorptiometry at the baseline and final visits. These measurements will take place immediately and a complete dataset will be compiled upon study completion.

Time frame
Through study completion, up to 1.5 years.

Sponsors and contacts

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