NCT03232970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 26, 2017

Last Update Submit

July 30, 2019

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    weight and height will be combined to report BMI in kg/m\^2

    3 months

Secondary Outcomes (3)

  • Body Fat

    3 months

  • Lipids

    3 months

  • HbA1C

    3 months

Study Arms (2)

FPD group

EXPERIMENTAL

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

Other: Full Plate Diet

FPD Control group

NO INTERVENTION

This group will receive all the assessments before, during and after the three months program period but will not attend the weekly lectures.

Interventions

Full Plate DietOTHER

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

FPD group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any gender and age between 21-65 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Related Publications (1)

  • 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.

    PMID: 27030531BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

February 26, 2018

Primary Completion

July 2, 2018

Study Completion

July 2, 2018

Last Updated

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)