Effect of Phosphorus Supplementation on Body Weight

Body Weight Clinical Trial

Official title:

Premeal Phosphorus Supplementation for Reducing Energy Intake and Body Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329990
• Other study ID #: NUT:00.11
• Status: Completed
• Phase: N/A
• First received: December 30, 2014
• Last updated: January 7, 2016
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Weight

Intervention

Dietary Supplement:
• phosphorus
phosphorus supplement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight		3 months	No
Secondary	Waist Circumference		3 months	No
Secondary	Appetite Score on the Visual Analog Scale		6 weeks	No