Bioavailability of phosphorus after oral intake of two hypoallergenic infant formulas in healthy adult volunteers with a neutral stomach pH

Bioavailability of phosphorus after oral intake of two hypoallergenic infant formulas in healthy adult volunteers with a neutral stomach pH - UP2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46087

Enrollment

Registered

2018-10-01

Start date

2018-11-06

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

Cow's milk allergy

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age * 18 and * 40 years - Body Mass Index (BMI) * 18.5 and * 24.9 kg/m2 - Non-Asian race* - Willingness and ability to comply with the protocol - Willingness to use a method of birth control during participation in the study (only women) - Written informed consent - Judged by the investigator to be in good health;*(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, celiac disease. diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, (gastro)enteritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator. - Known renal or hepatic failure or known thyroid dysfunction - Known food allergy and/or food intolerance for: cow*s milk, lactose, peanuts, nuts, wheat, soy, potato, carrot, onion, tomato, corn, apple and/or orange - 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 in this study is the serum P AUC0-360 [mmol/L*min] (product A versus 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] Cmin [mmol/L] and Tmin [min] - Urinary P [mmol/L] Cmax [mmol/L], AUC70-370 [mmol/Lmin] and Tmax [min] - Serum Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC0-360 [mmol/Lmin], iAUC0-360 [mmol/Lmin] and Tmax [min] - Urinary Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC70-370 [mmol/Lmin], iAUC70-370 [mmol/L*min] 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] Cmin [mmol/L] and Tmin [min] - Urinary P [mmol/L] Cmax [mmol/L], AUC70-370 [mmol/L*min] and Tmax [min] - Serum Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC0-360 [mmol/L*min], iAUC0-360 [mmol/L*min] and Tmax [min] - Urinary Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC70-370 [mmol/L*min], iAUC70-370 [mmol/L*min] and Tmax [min]

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)