NCT00728065

Brief Summary

Salvia hispanic (Salba) is postulated to increase satiety. This study determines the optimal amount of Salba as well as whether liquid or solid enriched products will produce maximum satiety. The results can gauge the effectiveness of Salba in weight loss programs. The study has a randomized, double-blind crossover design which includes 10 test meals and capillary blood sampling to perform glucose and insulin analyses (to determine blood glucose response and blood insulin response).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

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

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

August 1, 2008

Last Update Submit

February 17, 2009

Conditions

Post Prandial Blood Glucose

Outcome Measures

Primary Outcomes (1)

  • Post prandial capillary blood glucose levels

    2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour

Secondary Outcomes (1)

  • Patient completed satiety questionnaire

    2 hour period, Every 15 minutes for first hour, every 30 minutes for second hour

Study Arms (10)

1

EXPERIMENTAL

White Bread (control)

Dietary Supplement: White Bread

2

EXPERIMENTAL

White Bread (control)

Dietary Supplement: White Bread

3

EXPERIMENTAL

White bread with 7.32 grams Salba hispanica

Dietary Supplement: White bread with added 7.32g Salvia hispanica

4

EXPERIMENTAL

White bread with 15.58 grams Salba hispanica

Dietary Supplement: White bread with added 15.58g Salvia hispanica

5

EXPERIMENTAL

White bread with 24 grams Salba hispanica

Dietary Supplement: White bread with added Salvia hispanica

6

EXPERIMENTAL

Rice Milk (control)

Dietary Supplement: Rice milk

7

EXPERIMENTAL

Rice Milk (control)

Dietary Supplement: Rice milk

8

EXPERIMENTAL

Rice Milk with 7.32 grams Salba hispanica

Dietary Supplement: Enriched rice milk containing 7.32g Salvia hispanica

9

EXPERIMENTAL

Rice Milk with 15.58 grams Salba hispanica

Dietary Supplement: Enriched rice milk containing 15.58g Salvia hispanica

10

EXPERIMENTAL

Rice Milk with 24 grams Salba hispanica

Dietary Supplement: Enriched rice milk containing 24g Salvia hispanica

Interventions

White BreadDIETARY_SUPPLEMENT

About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water

12
White bread with added 7.32g Salvia hispanicaDIETARY_SUPPLEMENT

About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water

3
White bread with added 15.58g Salvia hispanicaDIETARY_SUPPLEMENT

About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water

4
White bread with added Salvia hispanicaDIETARY_SUPPLEMENT

About 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water

5
Rice milkDIETARY_SUPPLEMENT

Rice milk containing 50g of available carbohydrates

67
Enriched rice milk containing 7.32g Salvia hispanicaDIETARY_SUPPLEMENT

Rice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica

8
Enriched rice milk containing 15.58g Salvia hispanicaDIETARY_SUPPLEMENT

Rice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica

9
Enriched rice milk containing 24g Salvia hispanicaDIETARY_SUPPLEMENT

Rice milk containing 50g of available carbohydrates with 24g added Salvia hispanica

10

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 20-35 kg/m2

You may not qualify if:

  • Endocrine disease (adrenal disorders, glucose homeostasis disorders, metabolic bone diseases, pituitary gland disorders, parathyroid gland disorders, thyroid disorders)
  • Pregnancy
  • Use of drugs that influence carbohydrate metabolism (e.g. systemic glucocorticoids, beta blockers, thiazide diuretics)
  • Use of fiber supplements
  • Substance abuse (including regular smoking)
  • Digestive or malabsorption disorders (malabsorption syndrome, Crohn's disease, stomach ulcer, duodenal ulcer or intestinal parasites)
  • Presence of any significant disease or condition, including emotional or psychiatric disorders, that, in the opinion of the investigator, is likely to alter the metabolic state or interfere with the subject's ability to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, M5C 2T2, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 5, 2008

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

February 1, 2009

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

CA(1)