NCT01075568

Brief Summary

To examine the satiety effect after eating of Okara.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 3, 2010

Status Verified

February 1, 2010

Enrollment Period

7 months

First QC Date

February 17, 2010

Last Update Submit

March 2, 2010

Conditions

Healthy People

Outcome Measures

Primary Outcomes (1)

  • To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.

Interventions

Nutrigal Okara - 100DIETARY_SUPPLEMENT

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • Age 20-65 years old
  • Written Informed Consent

You may not qualify if:

  • History of gastro-intestinal surgery
  • On medication that may influence gastric emptying, or medication for weight loss
  • Patient on PPI treatment, H2 Blockers or medication for weight loss
  • Known allergies to soy
  • Pregnancy or breast-feeding
  • Smoking
  • Athletes
  • Metabolic syndrome or diabetes mellitus
  • Family history of metabolic syndrome or diabetes mellitus
  • Weight loss \> 2 kg during two months before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Central Study Contacts

Nachum Vaisman, Prof'

CONTACT

009-972-3-6974807vaisman@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 25, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

March 3, 2010

Record last verified: 2010-02

Locations

IL(1)