Full Plate Diet Study

Diet Modification Clinical Trial

— FPDCT  

Official title:

Full Plate Diet Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232970
• Other study ID #: 5170138
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: July 2, 2018

Study information

• Verified date: July 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification

Intervention

Other:
• Full Plate Diet
12 weekly sessions on how to incorporate more fiber in the diet.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Ardmore Institute of Health

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2	3 months
Secondary	Body Fat	Body Fat % measured by InBody 520 BIA machine	3 months
Secondary	Lipids	Measure of Total Cholesterol, HDL Cholesterol, LDL Cholesterol, and Triglycerides	3 months
Secondary	HbA1C	Glycated Hemoglobin	3 months