Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
11 April 2016 |
Main ID: |
NCT02278757 |
Date of registration:
|
27/10/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Effect of Two Diets With Different Content of Protein on Weight Loss in Adults With Metabolic Syndrome
DPMS |
Scientific title:
|
Effect of Enriched Meal Replacements Protein on Weight Loss in Adults With Metabolic Syndrome |
Date of first enrolment:
|
January 2014 |
Target sample size:
|
118 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02278757 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Mexico
| | | | | | | |
Contacts
|
Name:
|
Simon Barquera, PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Mexican Institute of Public Health |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adults with metabolic syndrome
Exclusion Criteria:
- Bariatric surgery for weight loss
- Smoking
- Use of alcohol or drugs
- Psychiatric disorders
- Anti-obesity medication
- Soy protein intolerance
- Women not using birth control methods
- Not pregnant or lactating
- Body weight gain or loss greater than two percent three months prior to the start of
the study
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Metabolic Syndrome X
|
Weight Loss
|
Intervention(s)
|
Other: High protein diet
|
Other: Low protein diet
|
Primary Outcome(s)
|
Changes in body weight (weight loss)
[Time Frame: Six months]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|