NCT02621307

Brief Summary

The purpose of this study is to determine whether drinks containing Salvia hispanica L (Salba) or Flax lower postprandial blood glucose levels and improve appetite in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2010

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

July 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
Last Updated

December 3, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 27, 2015

Last Update Submit

December 1, 2015

Conditions

Hyperglycemia, Postprandial

Keywords

postprandial glycemiasubjective appetiteSalbaFlax

Outcome Measures

Primary Outcomes (1)

  • Change in Postprandial Blood Glucose

    At each visit, postprandial blood glucose will be measured via capillary blood samples, at 15, 30, 45, 60, 90, and 120 minutes after intake of test meals

    2 Hours

Secondary Outcomes (1)

  • Change in Subjective Satiety

    2 Hours

Study Arms (3)

Salba

EXPERIMENTAL

50g glucose 25g ground Salba (Salba Corporation Ltd, Buenos Aires, Argentina) 200ml water

Dietary Supplement: Salba

Flax

EXPERIMENTAL

50g glucose 31g ground Flax (Bob's Red Mill Natural Raw Whole Flaxseed) 200ml water

Dietary Supplement: Flax

Control

PLACEBO COMPARATOR

50g glucose 200ml water

Dietary Supplement: Control

Interventions

SalbaDIETARY_SUPPLEMENT
Also known as: Salvia hispanica L
Salba
FlaxDIETARY_SUPPLEMENT
Flax
ControlDIETARY_SUPPLEMENT
Also known as: Glucose
Control

Eligibility Criteria

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

You may qualify if:

  • BMI less than 35 kg/m\^2

You may not qualify if:

  • known history of liver or kidney disease, diabetes, hypertension, stroke, or myocardial infarctions, thyroid disease, gastrointestinal disease, or AIDS
  • subjects using medications or Natural Health Products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Linseed OilGlucose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesHexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist & Professor

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 3, 2015

Study Start

July 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 3, 2015

Record last verified: 2015-11

Locations

CA(1)