Effect of Phosphorus Supplementation on Body Weight
Primary Purpose
Body Weight
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phosphorus
Sponsored by
About this trial
This is an interventional basic science trial for Body Weight focused on measuring phosphorus intake
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
phosphorus
placebo
Arm Description
phosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner)
ingestion of placebo tablets with each meal ( breakfast, lunch, dinner)
Outcomes
Primary Outcome Measures
Body Weight
Secondary Outcome Measures
Waist Circumference
Appetite Score on the Visual Analog Scale
Full Information
NCT ID
NCT02329990
First Posted
December 30, 2014
Last Updated
January 7, 2016
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02329990
Brief Title
Effect of Phosphorus Supplementation on Body Weight
Official Title
Premeal Phosphorus Supplementation for Reducing Energy Intake and Body Weight
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
phosphorus intake
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phosphorus
Arm Type
Active Comparator
Arm Description
phosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
ingestion of placebo tablets with each meal ( breakfast, lunch, dinner)
Intervention Type
Dietary Supplement
Intervention Name(s)
phosphorus
Intervention Description
phosphorus supplement
Primary Outcome Measure Information:
Title
Body Weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Waist Circumference
Time Frame
3 months
Title
Appetite Score on the Visual Analog Scale
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Obeid, PhD
Organizational Affiliation
AUB
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26690287
Citation
Ayoub JJ, Samra MJ, Hlais SA, Bassil MS, Obeid OA. Effect of phosphorus supplementation on weight gain and waist circumference of overweight/obese adults: a randomized clinical trial. Nutr Diabetes. 2015 Dec 21;5(12):e189. doi: 10.1038/nutd.2015.38.
Results Reference
derived
Learn more about this trial
Effect of Phosphorus Supplementation on Body Weight
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