Bioavailability of phosphorus after oral intake of hypoallergenic infant formula with additional phosphate sources in healthy adult volunteers with a neutral stomach pH.

Bioavailability of phosphorus after oral intake of hypoallergenic infant formula with additional phosphate sources in healthy adult volunteers with a neutral stomach pH. - UP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46664

Enrollment

Registered

2017-11-15

Start date

2018-02-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cows milk allergy

Interventions

In this study two study products will be investigated: - Product A: New hypoallergenic infant formula in one serving - Product B: Current hypoallergenic infant formula in one serving

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age * 18 and * 40 years - Non-Asian race* - Body Mass Index (BMI) * 18.5 and * 24.9 kg/m2 - Willingness and ability to comply with the protocol - Willingness to use a method of birth control during participation in the study (women only) - Written informed consent - Judged by the investigator to be in good health;*Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.

Exclusion criteria

Exclusion criteria: - Any medical condition that interferes significantly with digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, diaphraghma hernia or diaphraghma surgery, gastric ulcer, gastritis, (gastro)enteritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery) - Known renal or hepatic failure or known thyroid dysfunction - Any known food allergy and/or food intolerance - Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment - Serum 25(OH)D of

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter in this study is the serum P AUC 0-360 [mmol/L*min] (product A compared to product B).	—

Secondary

Measure	Time frame
The secondary outcome parameters in this study are comparisons of product A and B on: - Serum P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], Tmax [min] - Serum Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC0-360 [mmol/Lmin], iAUC0-360 [mmol/Lmin], Tmax [min] - Serum creatinine [µmol/L] (product A - B), Cmax, AUC0-360 [µmol/Lmin], Tmax [min] - Serum iPTH [pmol/L] (product A - B), Cmax, AUC0-360 [pmol/Lmin], Tmax [min] - Serum AP [U/L] (product A - B), Cmax, AUC0-360 [U/Lmin], Tmax [min] - Urinary P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC0-370 [mmol/Lmin], iAUC0-370 [mmol/Lmin] and Tmax [min] - Urinary Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC0-370 [mmol/Lmin], iAUC0-370 [mmol/Lmin] and Tmax [min] - Urinary creatinine [mmol/L] (product A - B), Cmax, AUC0-370 [mmol/Lmin] and Tmax [min]	—

Measure

Time frame

The secondary outcome parameters in this study are comparisons of product A and B on: - Serum P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], Tmax [min] - Serum Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC0-360 [mmol/L*min], iAUC0-360 [mmol/L*min], Tmax [min] - Serum creatinine [µmol/L] (product A - B), Cmax, AUC0-360 [µmol/L*min], Tmax [min] - Serum iPTH [pmol/L] (product A - B), Cmax, AUC0-360 [pmol/L*min], Tmax [min] - Serum AP [U/L] (product A - B), Cmax, AUC0-360 [U/L*min], Tmax [min] - Urinary P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC0-370 [mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min] - Urinary Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC0-370 [mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min] - Urinary creatinine [mmol/L] (product A - B), Cmax, AUC0-370 [mmol/L*min] and Tmax [min]

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)