Imbalance of Constituents of Food IntakeNCT02594787
The Effect of Phosphorus on Diet Induced Thermogenesis
A study testing Phosphorus in people with Imbalance of Constituents of Food Intake and Healthy, run by Lebanese American University.
Trial summary
The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite (using visual analogue scales) in lean and obese healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Imbalance of Constituents of Food Intake, Healthy
- What is being tested?
- Phosphorus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jan 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Sedentary lifestyle
- Stable weight for the past 3 months
- On a balanced diet
Who cannot join
- Underweight (BMI<18.5) or overweight/obese (BMI≥25)
- age <18 or > 30 years
- Inability to give valid consent
- Presence of a chronic or acute illness.
- Elevated physical activity level (assesses by the physical activity questionnaire)
- Heavy smokers (≥1 pack per day).
- Weight gain or loss of > 3% in the past 3 months
- History of kidney stones
About this study
The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite (using visual analogue scales) in lean and obese healthy subjects
- Conditions
- Imbalance of Constituents of Food Intake, Healthy
- Being tested
- Phosphorus, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhosphorusDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Phosphorus | Active comparator | Intervention (500 mg of potassium phosphate) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards Receives: Dietary Supplement: Phosphorus |
| Placebo | Placebo comparator | Placebo (cellulose) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Induced Thermogenesis
Diet Induced Thermogenesis will be measured using indirect calorimetry (VO2 consumption)
Measured: 180 minutes (measured every 30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMar 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imbalance of Constituents of Food IntakeStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Bassil, Lebanese American University
- Investigators
- Maya Bassil, PhD, Principal investigator, Lebanese American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594787
- Sponsor's protocol ID
- LAU.SOAS.MB1.2012.R1.11
- Status last verified
- Nov 2015
- First submitted
- 1 Nov 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phosphorus on Diet Induced Thermogenesis
- ClinicalTrials.gov ID
- NCT02594787
- Acronym / sponsor ID
- LAU.SOAS.MB1.2012.R1.11
- Conditions
- Imbalance of Constituents of Food Intake, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Nov 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.
The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite (using visual analogue scales) in lean and obese healthy subjects
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phosphorus | Active comparator | Dietary Supplement: PhosphorusIntervention (500 mg of potassium phosphate) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (cellulose) will be administered with 75 g glucose solution and diet induced thermogenesis will be measured afterwards |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Sedentary lifestyle
- Stable weight for the past 3 months
- On a balanced diet
Key exclusion criteria (8 listed)
- Underweight (BMI<18.5) or overweight/obese (BMI≥25)
- age <18 or > 30 years
- Inability to give valid consent
- Presence of a chronic or acute illness.
- Elevated physical activity level (assesses by the physical activity questionnaire)
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 |
|---|---|---|
| Phosphorus | Dietary supplement | Phosphorus |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Diet Induced Thermogenesis
Time frame: 180 minutes (measured every 30 min)
Diet Induced Thermogenesis will be measured using indirect calorimetry (VO2 consumption)
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 3 Nov 2015.
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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.
Maya Bassil, PhD principal investigator
Lebanese American University
Questions about this trial
What is this clinical trial studying?
A study testing Phosphorus in people with Imbalance of Constituents of Food Intake and Healthy, run by Lebanese American University.
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 4 inclusion and 8 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 3 Nov 2015. 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?
Diet Induced Thermogenesis (time frame: 180 minutes (measured every 30 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2015.