Effect of Phosphorus Supplementation on Body Weight

NCT ID: NCT02329990

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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phosphorus

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

Group Type ACTIVE_COMPARATOR

phosphorus

Intervention Type DIETARY_SUPPLEMENT

phosphorus supplement

placebo

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

Group Type PLACEBO_COMPARATOR

phosphorus

Intervention Type DIETARY_SUPPLEMENT

phosphorus supplement

Interventions

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phosphorus

phosphorus supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Omar Obeid

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Obeid, PhD

Role: PRINCIPAL_INVESTIGATOR

AUB

References

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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.

Reference Type DERIVED
PMID: 26690287 (View on PubMed)

Other Identifiers

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NUT:00.11

Identifier Type: -

Identifier Source: org_study_id

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