NCT03716479

Brief Summary

This study will provide needed insight on the satiety and blood glucose and l effects of the soluble fiber gum acacia at 20g and 40g doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

August 29, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

August 29, 2018

Last Update Submit

October 3, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood glucose levels

    Blood will be taken via finger stick

    0, 30, 60, 120, 180, and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment

  • Appetite Sensation

    Subjective visual analog scale (VAS) will be utilized to assess hunger, fullness and desire to eat

    15, 30, 45, 60, 90, 120, 180 and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment

Study Arms (3)

0 fiber

EXPERIMENTAL

0 grams fiber added to orange juice

Other: Placebo/Control

low fiber

EXPERIMENTAL

20 grams of acacia gum added to orange juice

Other: Low Fiber

high fiber

EXPERIMENTAL

40 grams of acacia gum added to orange juice

Other: High Fiber

Interventions

20 g of acacia gum will be added to orange juice

low fiber

40 g of acacia gum will be added to orange juice

high fiber

No acacia gum will be added to orange juice.

0 fiber

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • distaste for bagels and cream cheese, orange juice or cheese pizza;
  • current smoker;
  • restrained eating habits;
  • recent weight change;
  • any history of disease or significant past medical history;
  • are vegetarian;
  • do not normally eat breakfast or lunch;
  • pregnant or lactating;
  • irregular menstrual cycles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science and Nutrition

Saint Paul, Minnesota, 55108, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
fiber will be mixed into orange juice
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: subjects will consume 0, and 2 doses of acacia gum
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

October 23, 2018

Study Start

October 9, 2018

Primary Completion

August 31, 2019

Study Completion

September 1, 2019

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations