ObesityPinDITNCT02482142
The Role of Phosphorus in Diet Induced Thermogenesis (DIT) of Both Lean and Obese Subjects
A study testing Effect of phosphorus in people with Obesity, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The study aim at: Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high carbohydrate meal. Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Effect of phosphorus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteLebanon
- Study dates
- 30 Jul 2016to 30 Oct 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- lean subjects (BMI between 20 and 25);
- obese (BMI above 30) subjects
Who cannot join
- Pregnant and lactating women
- Subjects on regular use of medication that affects body weight
- weight loss of 3% or more in the preceding 3 months
- Subjects with kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Phosphorus in Diet Induced Thermogenesis of Both Lean and Obese Subjects
The study aim at:
Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high carbohydrate meal.
Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal.
Read the detailed description
Subject will be advice to take a weight maintenance diet which contains at least 250-300g of carbohydrate per day for the 3 days before each study day and also he/she will be asked to avoid any intense physical activity during the day before the day of the test. Overnight fasted subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. The he investigators will take the anthropometric measurements (weight, height, waist circumference) and determine blood glucose.
A crossover design study will be used in which each subject will undertake 2 or 3 sessions in a random order over 2 or 3 different days which are separated by a minimum of one week. The difference between the sessions is the ingestion of placebo ( 4 tablets) or phosphorus (4 tablets, each contain 125mgof phosphorus) tablets with the appropriate meal.
Specific Aim 1: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high carbohydrate meal (Table 1: Meal 1).
This will be divided into two experiments:
Experiment 1.1: The impact of phosphorus ingestion on DIT of lean subjects consuming high carbohydrate meal (16 subjects).
In this experiment, overnight fasted lean subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure resting energy expenditure (REE) for 30 min, ingest meal with the appropriate supplement and measure postprandial energy expenditure (PEE) for 4 hours (see figure 3). In this experiment, subject will undertake 3 sessions in a random order over 3 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tablets) alone. No meal. Needed to determine the impact of phosphorus alone on DIT Session 2: Ingestion of phosphorus tablets (4 tablets) with the high carbohydrate meal (table1: Meal 1).
Session 3: Ingestion of placebo tablets (4 tablets) with the high carbohydrate meal (table 1: Meal 1).
Experiment 1.2: The impact of phosphorus ingestion on DIT of lean subjects consuming high carbohydrate meal (16 subjects).
In this experiment, overnight fasted obese subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure resting REE for 30 min, ingest meal with the appropriate supplement and measure PEE for 4 hours (see figure 3). In this experiment, subject will undertake 3 sessions in a random order over 3 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tables) alone. No meal. Needed to determine the impact of phosphorus alone on DIT Session 2: Ingestion of phosphorus tablets (4 tables) with the high carbohydrate meal (Table 1:Meal 1).
Session 3: Ingestion of placebo tablets (4 tables) with the high carbohydrate meal (Table 1:Meal 1).
Specific Aim 2: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal (table 1: Meal 2).
This will be divided into two experiments:
Experiment 2.1: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal (16 subjects).
In this experiment, overnight fasted lean subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure REE for 30 min, ingest meal with the appropriate supplement and measure PEE for 4 hours (see figure 3). In this experiment, subject will undertake 2 sessions in a random order over 2 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tablets) with the high protein meal (table1: Meal 2).
Session 2: Ingestion of placebo tablets (4 tablets) with the high protein meal (table 1: Meal 2).
Experiment 2.2: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal (16 subjects).
In this experiment, overnight fasted obese subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure REE for 30 min, ingest meal with the appropriate supplement and measure PEE for 4 hours (see figure 3). Urine sample over the experimental period will be collected. In this experiment, subject will undertake 2 sessions in a random order over 2 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tablets) with the high protein meal (table1: Meal 2).
Session 2: Ingestion of placebo tablets (4 tablets) with the high protein meal (table 1: Meal 2).
- Conditions
- Obesity
- Being tested
- Effect of phosphorus
- Keywords
- phosphorus, lean, obese, energy expenditure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of phosphorusDietary supplement
Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)
| Study group | Role | What they receive |
|---|---|---|
| phosphorus alone | Placebo comparator | Effect of phosphorus (500mg) ingestion alone. No meal. Needed to determine the impact of phosphorus alone on DIT Receives: Dietary Supplement: Effect of phosphorus |
| high CHO meal alone | Placebo comparator | Ingestion of placebo tablets with the high carbohydrate meal Receives: Dietary Supplement: Effect of phosphorus |
| High CHO meal plus phosphorus | Active comparator | Effect of phosphorus (500mg) tablets ingestion of DIT of the high carbohydrate meal Receives: Dietary Supplement: Effect of phosphorus |
| High protein meal plus phosphorus | Active comparator | Effect of phosphorus (500mg) tablets ingestion of DIT of the high protein meal Receives: Dietary Supplement: Effect of phosphorus |
| High protein meal alone | Placebo comparator | Ingestion of placebo tablets with the high protein meal Receives: Dietary Supplement: Effect of phosphorus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial energy expenditure
Changes in area under the curve (AUC) of postprandial energy expenditure as measured by determining postprandial the volume oxygen consumption (VO2) and the volume of carbon dioxide production (VCO2)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start30 Jul 2016
- Primary completion30 Aug 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar A Obeid, PhD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482142
- Sponsor's protocol ID
- NUT.OO.22
- Acronym
- PinDIT
- Status last verified
- Jan 2019
- First submitted
- 25 Mar 2015
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Phosphorus in Diet Induced Thermogenesis of Both Lean and Obese Subjects
- ClinicalTrials.gov ID
- NCT02482142
- Acronym / sponsor ID
- PinDIT / NUT.OO.22
- Conditions
- Obesity
- Keywords
- phosphorus, lean, obese, energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2016 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 Jun 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 study aim at:
Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high carbohydrate meal.
Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal.
Detailed description
Subject will be advice to take a weight maintenance diet which contains at least 250-300g of carbohydrate per day for the 3 days before each study day and also he/she will be asked to avoid any intense physical activity during the day before the day of the test. Overnight fasted subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. The he investigators will take the anthropometric measurements (weight, height, waist circumference) and determine blood glucose.
A crossover design study will be used in which each subject will undertake 2 or 3 sessions in a random order over 2 or 3 different days which are separated by a minimum of one week. The difference between the sessions is the ingestion of placebo ( 4 tablets) or phosphorus (4 tablets, each contain 125mgof phosphorus) tablets with the appropriate meal.
Specific Aim 1: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high carbohydrate meal (Table 1: Meal 1).
This will be divided into two experiments:
Experiment 1.1: The impact of phosphorus ingestion on DIT of lean subjects consuming high carbohydrate meal (16 subjects).
In this experiment, overnight fasted lean subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure resting energy expenditure (REE) for 30 min, ingest meal with the appropriate supplement and measure postprandial energy expenditure (PEE) for 4 hours (see figure 3). In this experiment, subject will undertake 3 sessions in a random order over 3 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tablets) alone. No meal. Needed to determine the impact of phosphorus alone on DIT Session 2: Ingestion of phosphorus tablets (4 tablets) with the high carbohydrate meal (table1: Meal 1).
Session 3: Ingestion of placebo tablets (4 tablets) with the high carbohydrate meal (table 1: Meal 1).
Experiment 1.2: The impact of phosphorus ingestion on DIT of lean subjects consuming high carbohydrate meal (16 subjects).
In this experiment, overnight fasted obese subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure resting REE for 30 min, ingest meal with the appropriate supplement and measure PEE for 4 hours (see figure 3). In this experiment, subject will undertake 3 sessions in a random order over 3 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tables) alone. No meal. Needed to determine the impact of phosphorus alone on DIT Session 2: Ingestion of phosphorus tablets (4 tables) with the high carbohydrate meal (Table 1:Meal 1).
Session 3: Ingestion of placebo tablets (4 tables) with the high carbohydrate meal (Table 1:Meal 1).
Specific Aim 2: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal (table 1: Meal 2).
This will be divided into two experiments:
Experiment 2.1: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal (16 subjects).
In this experiment, overnight fasted lean subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure REE for 30 min, ingest meal with the appropriate supplement and measure PEE for 4 hours (see figure 3). In this experiment, subject will undertake 2 sessions in a random order over 2 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tablets) with the high protein meal (table1: Meal 2).
Session 2: Ingestion of placebo tablets (4 tablets) with the high protein meal (table 1: Meal 2).
Experiment 2.2: The impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal (16 subjects).
In this experiment, overnight fasted obese subjects (> 8 hours) will be requested to attend the testing room at around 8:00 am. Anthropometric measurements (weight, height, waist circumference) will be taken, rest for 30 min, measure REE for 30 min, ingest meal with the appropriate supplement and measure PEE for 4 hours (see figure 3). Urine sample over the experimental period will be collected. In this experiment, subject will undertake 2 sessions in a random order over 2 different days which are separated by a minimum of one week.
Session 1: Ingestion of phosphorus tablets (4 tablets) with the high protein meal (table1: Meal 2).
Session 2: Ingestion of placebo tablets (4 tablets) with the high protein meal (table 1: Meal 2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| phosphorus alone | Placebo comparator | Dietary Supplement: Effect of phosphorusEffect of phosphorus (500mg) ingestion alone. No meal. Needed to determine the impact of phosphorus alone on DIT |
| high CHO meal alone | Placebo comparator | Dietary Supplement: Effect of phosphorusIngestion of placebo tablets with the high carbohydrate meal |
| High CHO meal plus phosphorus | Active comparator | Dietary Supplement: Effect of phosphorusEffect of phosphorus (500mg) tablets ingestion of DIT of the high carbohydrate meal |
| High protein meal plus phosphorus | Active comparator | Dietary Supplement: Effect of phosphorusEffect of phosphorus (500mg) tablets ingestion of DIT of the high protein meal |
| High protein meal alone | Placebo comparator | Dietary Supplement: Effect of phosphorusIngestion of placebo tablets with the high protein meal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- lean subjects (BMI between 20 and 25);
- obese (BMI above 30) subjects
Key exclusion criteria (4 listed)
- Pregnant and lactating women
- Subjects on regular use of medication that affects body weight
- weight loss of 3% or more in the preceding 3 months
- Subjects with kidney disease
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 |
|---|---|---|
| Effect of phosphorusIngestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus) | Dietary supplement | High CHO meal plus phosphorus, High protein meal alone, High protein meal plus phosphorus, high CHO meal alone, phosphorus alone |
Primary outcome
Change in postprandial energy expenditure
Time frame: 4 hours
Changes in area under the curve (AUC) of postprandial energy expenditure as measured by determining postprandial the volume oxygen consumption (VO2) and the volume of carbon dioxide production (VCO2)
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 12 Oct 2020.
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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 A Obeid, PhD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of phosphorus in people with Obesity, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 inclusion and 4 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 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in postprandial energy expenditure (time frame: 4 hours). 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 12 Oct 2020.