The Role of Phosphorus in Diet Induced Thermogenesis (DIT) of Both Lean and Obese Subjects
PinDIT
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jul 2016
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedStudy Start
First participant enrolled
July 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedOctober 12, 2020
January 1, 2019
3.1 years
March 25, 2015
October 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
4 hours
Study Arms (5)
phosphorus alone
PLACEBO COMPARATOREffect of phosphorus (500mg) ingestion alone. No meal. Needed to determine the impact of phosphorus alone on DIT
high CHO meal alone
PLACEBO COMPARATORIngestion of placebo tablets with the high carbohydrate meal
High CHO meal plus phosphorus
ACTIVE COMPARATOREffect of phosphorus (500mg) tablets ingestion of DIT of the high carbohydrate meal
High protein meal plus phosphorus
ACTIVE COMPARATOREffect of phosphorus (500mg) tablets ingestion of DIT of the high protein meal
High protein meal alone
PLACEBO COMPARATORIngestion of placebo tablets with the high protein meal
Interventions
Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)
Eligibility Criteria
You may qualify if:
- lean subjects (BMI between 20 and 25);
- obese (BMI above 30) subjects
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American University of Beirut
Beirut, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar A Obeid, PhD
American University of Beirut Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
June 26, 2015
Study Start
July 30, 2016
Primary Completion
August 30, 2019
Study Completion
October 30, 2019
Last Updated
October 12, 2020
Record last verified: 2019-01