- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07921693
The Impact of Dietary Phosphorus on Postprandial Metabolic Responses and Markers of Metabolic Health (DPMPG)
The Effect of Dietary Phosphorus Manipulation on Postprandial Glycemia
To examine the effects of dietary phosphorus availability, including supplementation and restriction conditions, on postprandial glucose responses in healthy adults.
Study Overview
Status
Detailed Description
Two randomized, controlled, crossover experiments were conducted in healthy adults. Experiment 1 evaluated a refined carbohydrate test meal with phosphorus supplementation (~684 mg potassium phosphate) versus placebo. Experiment 2 assessed a dairy-based test meal under normal phosphorus availability versus reduced bioavailability using the phosphate-binding agent sevelamer carbonate. Each experiment followed a 10-day protocol comprising two intervention phases separated by a washout period. Within each phase, participants completed two identical test days per condition. Postprandial glucose was continuously monitored for 180 minutes. Primary outcomes included peak glucose, incremental glucose response (ΔBG), and incremental area under the curve (iAUC). Secondary outcomes included subjective appetite ratings assessed using validated visual analogue scale (VAS) questionnaires
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon
- American University of Beirut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Non diabetic
Exclusion Criteria:
- pregnancy or lactation
- diagnosis of diabetes
- recent weight loss (>3% within 3 months); psychiatric illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: refined low phosphorus carbohydrate meal
High-carbohydrate meal with low phosphorus content |
high-carbohydrate meal with 684 mg of phosphorus supplement |
|
Active Comparator: Full fat powdered milk meal
The meal or drink was composed of full-fat powdered milk meal which is naturally high in phosphorus |
Full fat dairy milk meal with 800 mg sevelamer carbonate (Renvela®) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postprandial glucose
Time Frame: 10 days
|
Monitoring glucose concentration |
10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite score
Time Frame: 180 minutes
|
changes in appetite scores between 0 -10 points |
180 minutes
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Hammoud RU, Jabbour MN, Tawil AN, Ghattas H, Obeid OA. Phosphorus Supplementation Mitigated Food Intake and Growth of Rats Fed a Low-Protein Diet. Curr Dev Nutr. 2017 Jul 27;1(8):e000943. doi: 10.3945/cdn.117.000943. eCollection 2017 Aug.
- Ragi ME, El Mallah C, Toufeili I, Obeid O. Concomitant lysine and phosphorus addition to a wheat gluten protein diet highly amplified growth measures of rats. Nutrition. 2019 Jul-Aug;63-64:69-74. doi: 10.1016/j.nut.2018.11.009. Epub 2018 Nov 30.
- El Khoury R, El Solh N, Olabi A, Toufeili I, Hlais S, Obeid O. Macromineral enrichment of white bread reduces postprandial glycaemia without altering sensory properties: a crossover study. East Mediterr Health J. 2020 Nov 11;26(11):1388-1395. doi: 10.26719/2020.26.11.1388.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BIO-2022-0015
- BIO-2022-0015 (Other Identifier: American University of Beirut)
- FMHS 392-1121 (Other Identifier: University of Nottingham)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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