NCT02329990

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

December 30, 2014

Last Update Submit

January 7, 2016

Conditions

Body Weight

Keywords

phosphorus intake

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    3 months

Secondary Outcomes (2)

  • Waist Circumference

    3 months

  • Appetite Score on the Visual Analog Scale

    6 weeks

Study Arms (2)

phosphorus

ACTIVE COMPARATOR

phosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner)

Dietary Supplement: phosphorus

placebo

PLACEBO COMPARATOR

ingestion of placebo tablets with each meal ( breakfast, lunch, dinner)

Dietary Supplement: phosphorus

Interventions

phosphorusDIETARY_SUPPLEMENT

phosphorus supplement

phosphorusplacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\>25
  • CR\>1mg/dl for women; Cr \>1.2 mg/dl for men
  • GFR \>60ml/min/1.73m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26690287DERIVED

MeSH Terms

Conditions

Body Weight

Interventions

Phosphorus

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElementsInorganic Chemicals

Study Officials

  • Omar Obeid, PhD

    AUB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 1, 2015

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

January 8, 2016

Record last verified: 2015-01