PinDIT: The Role of Phosphorus in Diet Induced Thermogenesis (DIT) of Both Lean and Obese Subjects

Sponsor
American University of Beirut Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02482142
Collaborator
(none)
64
1
5
39
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Effect of phosphorus
N/A

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

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Role of Phosphorus in Diet Induced Thermogenesis of Both Lean and Obese Subjects
Actual Study Start Date :
Jul 30, 2016
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Oct 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: phosphorus alone

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

Dietary Supplement: Effect of phosphorus
Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)

Placebo Comparator: high CHO meal alone

Ingestion of placebo tablets with the high carbohydrate meal

Dietary Supplement: Effect of phosphorus
Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)

Active Comparator: High CHO meal plus phosphorus

Effect of phosphorus (500mg) tablets ingestion of DIT of the high carbohydrate meal

Dietary Supplement: Effect of phosphorus
Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)

Active Comparator: High protein meal plus phosphorus

Effect of phosphorus (500mg) tablets ingestion of DIT of the high protein meal

Dietary Supplement: Effect of phosphorus
Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)

Placebo Comparator: High protein meal alone

Ingestion of placebo tablets with the high protein meal

Dietary Supplement: Effect of phosphorus
Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)

Outcome Measures

Primary Outcome Measures

  1. Change in postprandial energy expenditure [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • lean subjects (BMI between 20 and 25);

  • obese (BMI above 30) subjects

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 American University of Beirut Beirut Lebanon

Sponsors and Collaborators

  • American University of Beirut Medical Center

Investigators

  • Principal Investigator: Omar A Obeid, PhD, American University of Beirut Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT02482142
Other Study ID Numbers:
  • NUT.OO.22
First Posted:
Jun 26, 2015
Last Update Posted:
Oct 12, 2020
Last Verified:
Jan 1, 2019
Keywords provided by American University of Beirut Medical Center

Study Results

No Results Posted as of Oct 12, 2020