Health TrialsbyHealthPanel

Gut, Immune, and Vascular Health in Metabolically Healthy Obesity

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

About this trial

The investigators seek to better understand how a single high-fat meal impacts gut, immune, and vascular outcomes in individuals with "metabolically healthy obesity" (obesity and largely normal cardiometabolic profile) and "metabolically healthy normal-weight individuals." Second, the investigators seek to understand how a prebiotic fiber (inulin) impacts gut, immune, and vascular outcomes in individuals with "metabolically healthy obesity."

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-55 years old.

BMI is 18.5-24.9 kg/m2 or >30kg/m2 (part 1). BMI > 30 kg/m2 (part 2)

Not pregnant or expecting to become pregnant (females only).

Not postmenopausal (females only).

Disqualifiers

Not 18-55 years old.

BMI is not 18.5-24.9 kg/m2 or >30kg/m2 (part 1). BMI is not > 30 kg/m2 (part 2)

Pregnant or expecting to become pregnant (females only).

Postmenopausal (females only).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inulin Supplementation

    Dietary supplement

    Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).

  • Maltodextrin (Placebo)

    Dietary supplement

    Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).

  • High-fat meal

    Other intervention

    All participants in part 1 (both metabolically healthy normal weight and metabolically healthy obesity) will consume a high-fat meal designed to invoke changes in gut, immune, and vascular parameters.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Metabolically Healthy Obesity GroupExperimental treatment 3 interventions
Group B: Metabolically Healthy Normal Weight GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum lipopolysaccharide binding protein

Part 1: The investigators will measure lipopolysaccharide binding protein at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure lipopolysaccharide binding protein at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years
2

Serum interleukin-6

Part 1: The investigators will measure interleukin-6 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure interleukin-6 at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years.
3

Flow-mediated dilation

Part 1: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure flow-mediated dilation at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years
4

Serum C reactive protein

Part 2: The investigators will measure C reactive protein at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years

Secondary outcomes

1

Augmentation Index

Part 1: The investigators will measure augmentation index at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure augmentation index at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years
2

Pulse-wave velocity

Part 1: The investigators will measure pulse-wave velocity at baseline and 2-, 4-, 6-hours after the meal. Part 2: The investigators will measure pulse wave velocity at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years
3

Serum soluble CD14

Part 1: The investigators will measure serum soluble CD14 at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure serum soluble sCD14 at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years
4

Serum IL-1 beta

Part 1: The investigators will measure serum IL-1 beta at baseline and , 1-, 2-, 3-, 4-, 5-, and 6-hours after the meal. Part 2: The investigators will measure serum IL-1beta at baseline and 2-, 4-, and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years

Other outcomes

1

Body fat percent

Part 1: The investigators will measure body fat percent using Dual-Energy X-ray Absorptiometry. Part 2: The investigators will measure body fat percent using Dual-Energy X-ray Absorptiometry at baseline and 6-weeks post intervention.

Time frame
Through study completion, up to 2 years.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ball State University

Lead sponsor

Source ClinicalTrials.gov
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