Effect of Phosphorus Supplementation on Body Weight

Not Applicable

Completed

• Conditions: Body Weight
• Interventions: Dietary Supplement: phosphorus

• Registration Number: NCT02329990
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Study First Submitted: 2014-12-30
• Study First Submitted QC: 2014-12-31
• Status Verified: 2015-01
• Study First Posted: 2015-01-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	phosphorus	ingestion of placebo tablets with each meal ( breakfast, lunch, dinner)
phosphorus	phosphorus	phosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner)

Primary Outcome Measures

Name	Time	Method
Body Weight	3 months

Secondary Outcome Measures

Name	Time	Method
Waist Circumference	3 months
Appetite Score on the Visual Analog Scale	6 weeks