Full Plate Diet Study (FPDCT)

July 30, 2019 updated by: Hildemar Dos Santos, MD, DrPH, Loma Linda University

Full Plate Diet Clinical Trial

Comparison between two groups, experimental and control. Experimental will undergo lectures on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done before and after the 3-months long program. Comparisons will be made pre and post and with groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Full Plate Diet Clinical Trial is a study that will verify if the three months course is sufficient to change diet behavior of the participants. Forty participants will be recruited and then randomly assigned to one of two groups (20 in each group): The Experimental group will attend one weekly session with instructions on how to increase fiber intake; Control group will not have the intervention. The goal of the study is to see if the Full Plate Diet program will improve blood measures of metabolic diseases and weight.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any gender and age between 21-65 years

Exclusion Criteria:

  • BMI between 25 to 35,
  • no debilitating disease,
  • no previous participation in the FPD program,
  • no allergies to beans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FPD group
This group will undergo three months of weekly lectures to incorporate more fiber in their diet.
Other: Full Plate Diet
12 weekly sessions on how to incorporate more fiber in the diet.
No Intervention: FPD Control group
This group will receive all the assessments before, during and after the three months program period but will not attend the weekly lectures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: 3 months
weight and height will be combined to report BMI in kg/m^2
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Fat
Time Frame: 3 months
Body Fat % measured by InBody 520 BIA machine
3 months
Lipids
Time Frame: 3 months
Measure of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides
3 months
HbA1C
Time Frame: 3 months
Glycated Hemoglobin
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Collaborators

Ardmore Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Actual)

July 2, 2018

Study Completion (Actual)

July 2, 2018

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 27, 2017

First Posted (Actual)

July 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 5170138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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