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

Status

Completed

Conditions

Intervention / Treatment

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

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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