NCT02482142

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 30, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

October 12, 2020

Status Verified

January 1, 2019

Enrollment Period

3.1 years

First QC Date

March 25, 2015

Last Update Submit

October 9, 2020

Conditions

Keywords

phosphorusleanobeseenergy expenditure

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 COMPARATOR

Effect of phosphorus (500mg) ingestion alone. No meal. Needed to determine the impact of phosphorus alone on DIT

Dietary Supplement: Effect of phosphorus

high CHO meal alone

PLACEBO COMPARATOR

Ingestion of placebo tablets with the high carbohydrate meal

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

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

Dietary Supplement: Effect of phosphorus

High protein meal alone

PLACEBO COMPARATOR

Ingestion of placebo tablets with the high protein meal

Dietary Supplement: Effect of phosphorus

Interventions

Effect of phosphorusDIETARY_SUPPLEMENT

Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)

High CHO meal plus phosphorusHigh protein meal aloneHigh protein meal plus phosphorushigh CHO meal alonephosphorus alone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Omar A Obeid, PhD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations