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Almased Multi-Center Diabetes Intervention Trial

NCT01702012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-01-31

No results posted yet for this study

Summary

A 12 month multi-center randomization controlled study. Participants will be randomized to either a lifestyle education program or a meal replacement regimen with Almased, after an initial examination of eligibility criteria.

Primary outcome-HbA1c

Conditions

Interventions

DIETARY_SUPPLEMENT

Almased Meal Replacement Powder

Commercially available meal replacement product that contains soy protein, honey, yogurt, and amino acids. Participants assigned to this arm will receive the Almased meal replacement product and will be asked to replace one meal per day during the first 6 month. During the second 6 months, they will be allowed to choose to continue using the Almased as a meal replacement or to use it as a supplement prior to meals.

BEHAVIORAL

Group-Based Lifestyle Intervention

Sponsors & Collaborators

  • University of Freiburg

    collaborator OTHER

  • University of Campinas, Brazil

    collaborator OTHER

  • London Metropolitan University

    collaborator OTHER

  • University of Mysore

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Mara Z Vitolins, DrPH MPH RD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702012 on ClinicalTrials.gov