NCT01518088

Brief Summary

The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 21, 2016

Status Verified

January 1, 2012

Enrollment Period

1.8 years

First QC Date

January 20, 2012

Last Update Submit

April 20, 2016

Conditions

Focus of the Study is on Gut Health

Outcome Measures

Primary Outcomes (2)

  • Metabolizable energy

    Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy

    7 days, 3 times

  • Fermentability

    Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period

    One, eight-hr day, three times

Secondary Outcomes (2)

  • Fecal microbiota

    2 days, three times, and 7 days, three times

  • Blood glucose

    For eight hours, three times

Study Arms (3)

Low dose dietary fiber

EXPERIMENTAL
Dietary Supplement: Dietary Fiber

High dose dietary fiber

EXPERIMENTAL
Dietary Supplement: Dietary Fiber

No added fiber

PLACEBO COMPARATOR
Dietary Supplement: Dietary Fiber

Interventions

Dietary FiberDIETARY_SUPPLEMENT

Dietary fiber will be added to study foods

High dose dietary fiberLow dose dietary fiberNo added fiber

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index from 25 to 35 kg/m2.

You may not qualify if:

  • Pregnancy
  • Diabetes
  • Gastrointestinal disease
  • Regular use of pre- or probiotics
  • Recent use of antibiotics
  • High intake of dietary fiber

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nancy Keim, PhD

    ARS/USDA, University of California - Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 25, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 21, 2016

Record last verified: 2012-01

Locations

US(1)