NCT01469312

Brief Summary

The objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

April 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

1.5 years

First QC Date

November 3, 2011

Last Update Submit

November 9, 2011

Conditions

Blood Glucose ConcentrationType 2 DiabetesMetabolic Syndrome

Keywords

Low Biologically Available Glucose Diet (LoBAG diet)DiabetesGlycemic Index

Outcome Measures

Primary Outcomes (1)

  • Change in Blood Glucose

    Blood glucose will be determined by finger stick.

    0, 30, 60, 90, 120, and 180 minutes after ingestion

Study Arms (2)

Control

PLACEBO COMPARATOR

The control arm consists of the traditional pasta.

Other: modified pasta

Modified pasta

ACTIVE COMPARATOR

Dreamfields, Miracle Noodles

Other: modified pasta

Interventions

modified pastaOTHER

50 grams carbohydrate as a single breakfast meal

Also known as: Dreamfields Pasta, Miracle Noodles
ControlModified pasta

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal blood glucose concentration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

  • Nuttall FQ, Schweim K, Hoover H, Gannon MC. Effect of the LoBAG30 diet on blood glucose control in people with type 2 diabetes. Br J Nutr. 2008 Mar;99(3):511-9. doi: 10.1017/S0007114507819155. Epub 2007 Sep 10.

    PMID: 17868489BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic SyndromeDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Frank Q Nuttall, M.D., Ph.D.

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Mary C Gannon, Ph.D.

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Section of Endocrinology, Metabolism & Nutrition, Professor of Medicine

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 10, 2011

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

US(1)