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OpenTrials
Active, Not Recruiting

NCT Number: NCT06956131

Metabolite Changes Following Consumption Of Different Protein Drinks In Singapore Older Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Singapore, 117550

About this study

This study will be a double-blind, randomised, placebo-controlled trial using a crossover study design. 25 older adults (aged 60 to 80) will be recruited and assigned to consume 4 different test drinks in a random order on 4 different visits. This study aims to investigate whether higher protein consumption of different sources will influence postprandial plasma and urinary metabolomic profiles, cognition, mood and appetite. The study will comprise 1 screening visit and 4 test visits separated separated by a minimum washout period of >7 days

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • Taking anti-hypertensive or cholesterol-lowering drugs for less than 3 years unless medically declared by an official doctor to be in stable condition
  • Poor peripheral venous access based on past experiences with blood drawing

Treatment and study plan

Casein Protein Isolate Drink

Dietary Supplement

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

Whey Protein Isolate Drink

Dietary Supplement

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

Soy Protein Isolate Drink

Dietary Supplement

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

Maltodextrin Drink

Dietary Supplement

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

Primary outcomes

  1. Changes in metabolites found in plasma (plasma metabolomics)

    Time frame: Baseline, 15, 30, 60, 90, 120, 180, 240, 300 minutes

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

  2. Changes in metabolites found in urine (urinary metabolomics)

    Time frame: Baseline, 60, 120, 180, 240, 300 minutes

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

Secondary outcomes

  1. Cognitive Function

    Time frame: Baseline, 15, 60, 120, 180, 240, 300 minutes

    The Computerised Mental Performance Assessment System (COMPASS) will be administered via a laptop. The COMPASS tests consist of 5 consecutive tests, including Digit Vigilance, Stroop, Rapid Visual Information Processing, Computerised Corsi Blocks Lite, Alphabetic Working Memory and Serial Subtraction, where the correctness and reaction time will be recorded. The test is expected to take around 15 minutes.

  2. Mood

    Time frame: Baseline, 15, 60, 120, 180, 240, 300 minutes

    The Profile of Mood States (POMS) questionnaire will be administered, which contains various words that describe feelings. Participants will indicate, for each word, how they currently feel on scale of 0 (Not at all) to 4 (Extremely).

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • Bezos Earth Fund

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 2, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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