NCT02045342

Brief Summary

This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

January 22, 2014

Last Update Submit

January 23, 2014

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

  • Oxygen Consumption

    Four 10 minute measures throughout 90 min protocol (1 day).

Secondary Outcomes (2)

  • Appetite ratings

    Four appetite ratings throughout 90 min protocol (1 day).

  • Cognitive function

    2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).

Study Arms (2)

Carbohydrate drink

EXPERIMENTAL

Ingest 500ml (1g/kg) prior to metabolic measures.

Other: Carbohydrate drinkOther: Placebo

Placebo

PLACEBO COMPARATOR

Ingest 500ml of placebo prior to metabolic measures.

Other: Carbohydrate drinkOther: Placebo

Interventions

Carbohydrate drinkOTHER

Ingest 500ml (1g/kg) prior to metabolic measures.

Carbohydrate drinkPlacebo
PlaceboOTHER

Ingest 500ml of placebo prior to metabolic measures.

Carbohydrate drinkPlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, 18 to 35 year old man or woman.

You may not qualify if:

  • smoker
  • pregnancy
  • taking part in other research.
  • followed a weight loss diet in the previous 6 months.
  • history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
  • neurological or psychiatric condition that may cause cognitive dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Research Laboratory, Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Peter Lemon, PhD

CONTACT

519 661 2111plemon@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

CA(1)