NCT04596969

Brief Summary

This study examines the effect of soluble fiber dextrin on food intake, appetite, and physiological markers of appetite. Adults aged 18-45 years with a BMI were recruited for this study. Participants were given two doses of SFD in the morning and appetite, food intake and physiological markers of appetite were measured over 10 years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

January 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

October 15, 2020

Last Update Submit

October 15, 2020

Conditions

Appetitive Behavior

Outcome Measures

Primary Outcomes (1)

  • Food intake

    Food intake measured at lunch and evening meal.

    10 hours

Secondary Outcomes (5)

  • Appetite

    10 hours

  • CCK

    10 hours

  • GLP-1

    10 hours

  • PYY3-36

    10 hours

  • Breath Hydrogen

    10 hours

Study Arms (5)

SFD Tapioca 20g

EXPERIMENTAL

20g soluble fiber dextrin derived from tapioca

Other: Soluble Fiber Dextrin

SFD Tapioca 40g

EXPERIMENTAL

40g soluble fiber dextrin derived from tapioca

Other: Soluble Fiber Dextrin

SFD corn 20g

EXPERIMENTAL

40g soluble fiber dextrin derived from corn

Other: Soluble Fiber Dextrin

SFD corn 40g

EXPERIMENTAL
Other: Soluble Fiber Dextrin

Control

PLACEBO COMPARATOR

Maltodextrin

Other: Soluble Fiber Dextrin

Interventions

Soluble Fiber DextrinOTHER

Ingredient based on resistant starch

ControlSFD Tapioca 20gSFD Tapioca 40gSFD corn 20gSFD corn 40g

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 19.9 - 29.9 Aged 18-45 Find the study foods to be palatable

You may not qualify if:

  • Weight change \> 3kg in the past three months Do not regularly consume snacks Presence or history of GI disorders Restrained eater Used medication that influences appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Material was provided in coded plain packaging. Participants and researchers were unaware of what was being received.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Human subjects
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

October 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share