- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329990
Effect of Phosphorus Supplementation on Body Weight
January 7, 2016 updated by: Omar Obeid, American University of Beirut Medical Center
Premeal Phosphorus Supplementation for Reducing Energy Intake and Body Weight
Phosphorus is a mineral that is naturally present in our foods and is required by our bodies for normal function.
It has been found that phosphorus supplementation taken before meals has the potential to reduce meal size.
However its long term effect has not been measured yet.
It is well accepted that changes in body weight require about 3 months.
Using body weight as the outcome, which is the ultimate outcome of weight loss approaches, would provide robust information on the role of phosphorus.
Study Overview
Detailed Description
A double-blind, randomised, placebo-controlled trial of 63 adults aged 18 to 45 years with a body mass index (BMI) of 25 kg/m2 or higher and normal kidney function at the American University of Beirut.
Participants were randomly assigned to the placebo or phosphorus group where daily placebo or phosphorus supplements were ingested with three main meals (breakfast, lunch, and dinner) for a period of 12 weeks.
Primary outcomes were changes in anthropometric measures, blood metabolites (including lipid profile, glucose, and insulin), and subjective appetite scores.
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI>25
- CR>1mg/dl for women; Cr >1.2 mg/dl for men
- GFR >60ml/min/1.73m2
Exclusion Criteria:
- BMI<25
- presence of any significant medical disease,
- pregnancy or lactation,
- regular administration of drugs that affect body weight, and
- weight loss of 3% or more within 3 months of study entry.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: phosphorus
phosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner)
|
phosphorus supplement
|
Placebo Comparator: placebo
ingestion of placebo tablets with each meal ( breakfast, lunch, dinner)
|
phosphorus supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Weight
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Waist Circumference
Time Frame: 3 months
|
3 months
|
Appetite Score on the Visual Analog Scale
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Omar Obeid, PhD, AUB
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.
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
June 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
December 30, 2014
First Submitted That Met QC Criteria
December 31, 2014
First Posted (Estimate)
January 1, 2015
Study Record Updates
Last Update Posted (Estimate)
January 8, 2016
Last Update Submitted That Met QC Criteria
January 7, 2016
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUT:00.11
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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