NCT06956131

Brief Summary

The study aims to investigate the acute effects of different protein sources (i.e., casein, whey, soy) on metabolomic profiles (e.g., amino acids in the blood), along with other outcomes such as cognitive function, mood, and appetite. While the study does not directly aim to prevent, prognosticate, diagnose, or alleviate any disease, it may provide insights that could inform dietary recommendations and support disease prevention efforts in older adults.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress63%
May 2025Dec 2026

First Submitted

Initial submission to the registry

April 15, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

April 15, 2025

Last Update Submit

February 13, 2026

Conditions

AgingProtein Metabolism

Keywords

Older adultsMetabolomicsProtein intakeProtein metabolismAcutePostprandialCognitive functionMoodAppetite

Outcome Measures

Primary Outcomes (2)

  • Changes in metabolites found in plasma (plasma metabolomics)

    Untargeted metabolomics profiling of plasma will be conducted using ultra performance liquid chromatography-quadrupole time of flight-mass spectrometry (UPLC-QTOF-MS)

    Baseline, 15, 30, 60, 90, 120, 180, 240, 300 minutes

  • Changes in metabolites found in urine (urinary metabolomics)

    Untargeted metabolomics profiling of urine will be conducted using ultra performance liquid chromatography-quadrupole time of flight-mass spectrometry (UPLC-QTOF-MS)

    Baseline, 60, 120, 180, 240, 300 minutes

Secondary Outcomes (2)

  • Cognitive Function

    Baseline, 15, 60, 120, 180, 240, 300 minutes

  • Mood

    Baseline, 15, 60, 120, 180, 240, 300 minutes

Study Arms (4)

Casein Protein Drink

EXPERIMENTAL

30 g protein equivalent of casein protein isolate dissolved in \~250 mL of water

Dietary Supplement: Casein Protein Isolate Drink

Whey Protein Drink

EXPERIMENTAL

30 g protein equivalent of whey protein isolate dissolved in \~250 mL of water

Dietary Supplement: Whey Protein Isolate Drink

Soy Protein Drink

EXPERIMENTAL

30 g protein equivalent of soy protein isolate dissolved in \~250 mL of water

Dietary Supplement: Soy Protein Isolate Drink

Maltodextrin Drink

PLACEBO COMPARATOR

30 g carbohydrate equivalent of maltodextrin powder dissolved in \~250 mL of water

Dietary Supplement: Maltodextrin Drink

Interventions

Casein Protein Isolate DrinkDIETARY_SUPPLEMENT

30 g protein equivalent of casein protein isolate dissolved in \~250 mL of water

Casein Protein Drink
Whey Protein Isolate DrinkDIETARY_SUPPLEMENT

30 g protein equivalent of whey protein isolate dissolved in \~250 mL of water

Whey Protein Drink
Soy Protein Isolate DrinkDIETARY_SUPPLEMENT

30 g protein equivalent of soy protein isolate dissolved in \~250 mL of water

Soy Protein Drink
Maltodextrin DrinkDIETARY_SUPPLEMENT

30 g carbohydrate equivalent of maltodextrin powder dissolved in \~250 mL of water

Maltodextrin Drink

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-literate and able to give informed consent
  • Adults 60 to 80 years old (inclusive)
  • (If applicable) Postmenopausal
  • BMI of 18·5 to 30 kg/m2 (inclusive)

You may not qualify if:

  • Currently participating in another clinical study that involves altering the regular diet and/or involves consuming a dietary supplement or investigated food product as an intervention
  • Weight change \>3 kg in the past 3 months
  • Exercising vigorously over the past 3 months (i.e., engaging in high-intensity exercises for more than 3 hours a week, where high-intensity exercises leave one out of breath and unable to talk or sing during the workout)
  • Current smokers or have quit smoking for less than 5 years
  • Drinking \>2 alcoholic drinks per day (i.e., one drink is defined as either 150 ml of wine, 340 ml of beer/cider or 45 ml of distilled spirit)
  • If drinking ≤2 alcoholic drinks per day, not willing to stop consumption of alcoholic beverages two days before and on the day of the test visits (total 12 days)
  • Not willing to stop consumption of caffeinated beverages 10 to 12 hours before and on the day of the test visits (total 4 days)
  • Taking supplements containing omega-3, magnesium, gamma-aminobutyric acid (GABA), L-theanine, melatonin and/or 5-hydroxytryptophan for the past 3 months, and not willing to discontinue usage 3 months before and during the study duration
  • Currently on a specialised diet (e.g., vegetarian, vegan, weight loss diet)
  • Had serious food allergies in the past, or having intolerance, sensitivities or allergies to any of the following: milk/dairy products (e.g., casein, whey), starch/starch-derived products (e.g., rice, corn, wheat, potato), soy/soy-derived products, gluten, eggs, nuts, peanuts, fish and crustaceans.
  • Disease or impairment of the kidney and/or liver
  • Currently diagnosed with diabetes, sleep disorders, gastrointestinal issues (e.g., lactose intolerance, irritable bowel syndrome), gout and/or G6PD deficiency
  • History of diseases known to affect the central nervous system (e.g., heart disease, stroke, migraine headaches, multiple sclerosis, Parkinson's disease, mental illnesses)
  • Taking antibiotics 2 weeks prior to study participation
  • Taking medication known to interfere with cognitive function and mental wellbeing (e.g., benzodiazepines, antidepressants, other central nervous agents)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NUS, Department of Food Science and Technology, 1 Science Drive 3, Block S13, #03-07

Singapore, 117550, Singapore

Location

Related Publications (1)

  • Lanng SK, Oxfeldt M, Johansen FT, Risikesan J, Hansen M, Bertram HC. Acute changes in the metabolome following resistance exercise combined with intake of different protein sources (cricket, pea, whey). Metabolomics. 2023 Nov 24;19(12):98. doi: 10.1007/s11306-023-02064-0.

    PMID: 37999866BACKGROUND

Study Officials

  • Jung Eun Kim, Ph.D., R.D.

    National University of Singapore, Department of Food Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 15, 2025

First Posted

May 2, 2025

Study Start

May 20, 2025

Primary Completion

February 9, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 17, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Electronic copies of the data with identifiable participant information will be kept on NUS OneDrive with access limited only Dr Kim Jung Eun and her research staff. All data will be de-identified prior to statistical analyses.

Locations

SG(1)