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Effect of Phosphorus Supplementation on Body Weight

Primary Purpose

Body Weight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phosphorus
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Body Weight focused on measuring phosphorus intake

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 30, 2014
    Last Updated
    January 7, 2016
    Sponsor
    American University of Beirut Medical Center
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    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

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    Effect of Phosphorus Supplementation on Body Weight

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