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Trial record 1 of 1 for:    NCT02329990
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Effect of Phosphorus Supplementation on Body Weight

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ClinicalTrials.gov Identifier: NCT02329990
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Omar Obeid, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Body Weight Dietary Supplement: phosphorus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Premeal Phosphorus Supplementation for Reducing Energy Intake and Body Weight
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Phosphorus

Arm Intervention/treatment
Active Comparator: phosphorus
phosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner)
Dietary Supplement: phosphorus
phosphorus supplement

Placebo Comparator: placebo
ingestion of placebo tablets with each meal ( breakfast, lunch, dinner)
Dietary Supplement: phosphorus
phosphorus supplement




Primary Outcome Measures :
  1. Body Weight [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Waist Circumference [ Time Frame: 3 months ]
  2. Appetite Score on the Visual Analog Scale [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329990


Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Omar Obeid, PhD AUB

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Omar Obeid, professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02329990     History of Changes
Other Study ID Numbers: NUT:00.11
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2015
Keywords provided by Omar Obeid, American University of Beirut Medical Center:
phosphorus intake
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms