Full Plate Diet Study

NCT ID: NCT03232970

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2018-07-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FPD group

This group will undergo three months of weekly lectures to incorporate more fiber in their diet.

Group Type EXPERIMENTAL

Full Plate Diet

Intervention Type OTHER

12 weekly sessions on how to incorporate more fiber in the diet.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Full Plate Diet

12 weekly sessions on how to incorporate more fiber in the diet.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ardmore Institute of Health

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Hildemar Dos Santos, MD, DrPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status

Countries

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United States

References

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Kim SJ, de Souza RJ, Choo VL, Ha V, Cozma AI, Chiavaroli L, Mirrahimi A, Blanco Mejia S, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Effects of dietary pulse consumption on body weight: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2016 May;103(5):1213-23. doi: 10.3945/ajcn.115.124677. Epub 2016 Mar 30.

Reference Type BACKGROUND
PMID: 27030531 (View on PubMed)

Other Identifiers

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5170138

Identifier Type: -

Identifier Source: org_study_id

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