Body WeightNCT02329990
Effect of Phosphorus Supplementation on Body Weight
A study testing phosphorus in people with Body Weight, run by American University of Beirut Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- phosphorus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI>25
- CR>1mg/dl for women; Cr >1.2 mg/dl for men
- GFR >60ml/min/1.73m2
Who cannot join
- 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.
About this study
Official title: Premeal Phosphorus Supplementation for Reducing Energy Intake and Body Weight
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.
Read the 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.
- Conditions
- Body Weight
- Being tested
- phosphorus
- Keywords
- phosphorus intake
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phosphorusDietary supplement
phosphorus supplement
| Study group | Role | What they receive |
|---|---|---|
| phosphorus | Active comparator | phosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner) Receives: Dietary Supplement: phosphorus |
| placebo | Placebo comparator | ingestion of placebo tablets with each meal ( breakfast, lunch, dinner) Receives: Dietary Supplement: phosphorus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Measured: 3 months
Secondary outcomes (2)
Waist Circumference
Measured: 3 months
Appetite Score on the Visual Analog Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Obeid, American University of Beirut Medical Center
- Investigators
- Omar Obeid, PhD, Principal investigator, AUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329990
- Sponsor's protocol ID
- NUT:00.11
- Status last verified
- Jan 2015
- First submitted
- 30 Dec 2014
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26690287
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premeal Phosphorus Supplementation for Reducing Energy Intake and Body Weight
- ClinicalTrials.gov ID
- NCT02329990
- Acronym / sponsor ID
- NUT:00.11
- Conditions
- Body Weight
- Keywords
- phosphorus intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phosphorus | Active comparator | Dietary Supplement: phosphorusphosphorus ingestion (375mg) with each main meal ( breakfast, lunch, dinner) |
| placebo | Placebo comparator | Dietary Supplement: phosphorusingestion of placebo tablets with each meal ( breakfast, lunch, dinner) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI>25
- CR>1mg/dl for women; Cr >1.2 mg/dl for men
- GFR >60ml/min/1.73m2
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phosphorusphosphorus supplement | Dietary supplement | phosphorus, placebo |
Primary outcome
Body Weight
Time frame: 3 months
2 secondary outcomes
Waist Circumference
Time frame: 3 months
Appetite Score on the Visual Analog Scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Derived from this study: PubMed 26690287Ayoub 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Obeid, PhD principal investigator
AUB
Questions about this trial
What is this clinical trial studying?
A study testing phosphorus in people with Body Weight, run by American University of Beirut Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.