NCT02346838

Brief Summary

Forty-eight prediabetic men and women (50-75 years of age) will participate in a 6-week feeding study in which they will randomized to receive either 10 g/day of inulin or placebo. All subjects will be fed an isocaloric diet (50% carbohydrate, 35% fat, 15% protein,) controlled for micronutrient content for 6 weeks to avoid the potential confound of individual differences in diet on gut microbiota. Measurements of intestinal permeability, insulin sensitivity, and skeletal muscle metabolic flexibility will be made prior to and following the controlled feeding period. Stool samples will be collected to assess gut microbial communities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

January 7, 2015

Last Update Submit

March 23, 2026

Conditions

Prediabetes

Keywords

Prediabetes, prebiotics, metabolic endotoxemia

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity.

    Insulin sensitivity will be assessed via a frequently sampled intravenous glucose tolerance test.

    Baseline, 6 weeks

Secondary Outcomes (3)

  • Change in metabolic flexibility.

    Baseline, 6 weeks

  • Change in endothelial function.

    Baseline, 6 weeks

  • Change in arterial stiffness.

    Baseline, 6 weeks

Study Arms (2)

Inulin

EXPERIMENTAL

Participants will receive 10 g of inulin powder each day for 6 weeks.

Dietary Supplement: Inulin

Placebo

PLACEBO COMPARATOR

Participants will receive 10 g of maltodextrin each day for 6 weeks.

Dietary Supplement: Placebo

Interventions

InulinDIETARY_SUPPLEMENT

The treatment will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.

Also known as: Prebiotic
Inulin
PlaceboDIETARY_SUPPLEMENT

The placebo will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.

Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women; postmenopausal women not taking hormone replacement therapy.
  • Fasting glucose between 5.6 - 6.9 mmol/L and/or a 2h plasma glucose between 7.8-11.1 mmol/L following a 75 g oral glucose tolerance test.
  • Weight stable for previous 6 months (+/- 2.0 kg).
  • Sedentary to recreationally active
  • Willing to be randomized to treatment or placebo.
  • Verbal and written informed consent.
  • No plans to gain/lose weight or change physical activity level.
  • Willing to pick up food daily, and consume foods provided for the 6-week controlled feeding period.

You may not qualify if:

  • BMI less than 25 kg/m2 or greater than 40 kg/m2 or body mass greater than 300 pounds due to limit of DEXA.
  • Diabetes or diabetes medications
  • Prebiotic or probiotic supplement or product consumption in prior 3 months.
  • Total cholesterol \> 6.2 mmol/L; triglycerides \> 4.5 mmol/L.
  • Blood pressure \> 140/90 mmHg or antihypertensive medications.
  • Diagnosed inflammatory disease (e.g. lupus, irritable bowel, periodontal disease, etc)
  • Fructo, galacto-, xylo-oligosaccharide intake \> 3 g/day.
  • Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease.
  • Smoking, alcohol consumption \> 2 servings /d for males and 1 serving/d for females, or taking medications (including but not limited to statins or other drugs with anti-inflammatory actions) or antioxidant vitamins or supplements.
  • Known allergy, hypersensitivity, or intolerance to inulin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Polytechnic and State University

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

InulinPrebiotics

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharidesDietary FiberPolysaccharides, BacterialFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Kevin P Davy, PhD

    Virginia Polytechnic and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kevin P. Davy, PhD

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 27, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

July 1, 2018

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)