- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04076176
The Effects of CGMP in Children and Adults With PKU (ELEMENT)
The Effects Of Casein Glycomacropeptide On Metabolic Control And General Health Status In Children And Adults With PKU: A Randomised Crossover Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a randomised controlled trial with a crossover design conducted at several international study centres.
The study population is early and continuously treated patients with PKU that are adhering to their prescribed diet.
The participants will be given both a CGMP based protein substitute and a free AA based protein substitute as their main protein source on two different 12-week periods in a crossover design. The two periods will be separated by a 4 week wash out period.
The protein substitutes will be consumed daily together with the patient's regular low protein diet during the intervention periods.
Primary Objective The primary objective of the study is to investigate the effects of a CGMP based formula compared to an AA based formula upon mean plasma Phe levels after 12 weeks of daily intake in patients with PKU.
Secondary Objectives The secondary objectives of the study are to investigate if a CGMP based formula compared to an AA based formula in PKU patients provides any long-term health benefits concerning gut health, inflammation, oxidative stress and product acceptability.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kobenhavn, Denmark, 2100
- Rigshospitalet
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-
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Avon
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Bristol, Avon, United Kingdom, BS2 8BJ
- Bristol Royal Hospital for Children
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West Midlands
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Birmingham, West Midlands, United Kingdom, B4 6NH
- Birmingham Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PKU patient diagnosed on newborn screening (NBS).
- > 50% of protein intake from protein substitutes.
- (CHILDREN) Dietary intake of ≤ 1000 mg Phe from natural protein or ≤20 g natural protein inclusive of fruit and vegetables per day.
- (ADULTS) Dietary intake of ≤ 1500 mg Phe from natural protein or ≤ 30 g natural protein inclusive of fruit and vegetables per day.
- (CHILDREN) Three out of the last four consecutive Phe measurements within the target range (≤360 µmol/L in patients aged 4-12 years).
- (ADULTS) Two out of the last four consecutive Phe measurements within the target range (≤600 µmol/L for adults).
- Male or female aged 4-12 years or 18 years and over.
- Early and continuously treated. Adherent to their prescribed PKU diet consisting of a protein-restricted diet and free AA based protein substitute.
- Otherwise in good general health as evidenced by medical history.
- Able to provide written informed consent (patient or parent/guardian).
- Able to comply with the study protocol and take study product according to the opinion of the PI.
- Protein substitute intake provided by L-amino acid supplements only.
- (ADULTS) No studies have been done in pregnant women. To ensure patients safety, female patients of childbearing potential must have a negative pregnancy test prior to completing the screening procedures.
- (ADULTS) All female patients of childbearing potential and sexually mature males should be willing to use a medically accepted method of contraception throughout the study.
- Successful 3-day PKU Sphere taste test.
Exclusion Criteria:
- Concomitant diseases / disorders such as but not limited to renal or gut disease / disorders and diabetes.
- Currently or previously treated with tetrahydrobiopterin (BH4), pegylated recombinant phenylalanine ammonia lyase (PEG PAL), large neutral amino acids.
- Previous intake of CGMP for more than four consecutive weeks.
- Having a current infection.
- Known soya, milk or fish allergies / intolerance.
- Patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.
- Where applicable, patients not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: L-amino Acids
The specific amount and timing of L-amino acid consumption will be at the instruction of a dietitian following a review of the individual patient's dietary needs. Consumption period: 12 weeks. |
Patient may choose from a list of products, specified in the protocol, that are nutritionally comparable to PKU Sphere.
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Experimental: PKU Sphere
The specific amount and timing of PKU sphere consumption will be at the instruction of a dietitian following a review of the individual patient's dietary needs. Consumption period: 12 weeks. |
PKU sphere is a powdered, low phenylalanine protein substitute, containing a balanced mix of casein glycomacropeptide (CGMP) isolate, essential and non-essential amino acids, carbohydrate, vitamins, minerals, trace elements and the omega-3 long chain polyunsaturated fatty acid (LCP); docosahexaenoic acid.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in overnight fasting plasma Phe
Time Frame: Measured at days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5)
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Overnight fasting plasma phenylalanine level (μmol/l)
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Measured at days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5)
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Change in overnight fasting plasma Tyr
Time Frame: Measured at days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5)
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Overnight fasting plasma tyrosine level (μmol/l)
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Measured at days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5)
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Change in overnight fasting blood Phe
Time Frame: Measured twice per week up to 32 weeks
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Overnight fasting blood phenylalanine level (μmol/l) using blood spots
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Measured twice per week up to 32 weeks
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Change in overnight fasting blood Tyr
Time Frame: Measured twice per week up to 32 weeks
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Overnight fasting blood tyrosine level (μmol/l) using blood spots
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Measured twice per week up to 32 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gut health: PedsQL Gastrointestinal Symptoms Scales, Version 3.0
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Five point frequency scale for each question: Never (0), Almost Never (1), Sometimes (2), Often (3), Almost Always (4).
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in gut health: Stool pH for reducing sugars
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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From stool sample.
To rule out carbohydrate intolerance as a cause of any irritable bowel syndrome symptoms
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in gut health: Stool calprotectin
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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From stool sample
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in gut health: Short chain fatty acids
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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From stool sample
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in gut health: Immunoglobulin A
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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From stool sample
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in gut health: Bristol stool form scale
Time Frame: Completed for 7 days prior to days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Bristol stool form scale:
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Completed for 7 days prior to days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in gut health: 3 day weighed diet diary
Time Frame: Completed for 3 days prior to days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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3 day weighed diet diary
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Completed for 3 days prior to days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in anthropometric measurements: weight
Time Frame: Days -31 (visit 1), 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Weight (kg)
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Days -31 (visit 1), 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in anthropometric measurements: height
Time Frame: Days -31 (visit 1), 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Height (cm)
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Days -31 (visit 1), 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Albumin
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Pre-albumin
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Transferrin
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Retinol-binding protein
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Glucose
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Haemoglobin A1C
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in IGF-1
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in C-peptide
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Short chain fatty acids
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change insulin production
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in alanine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in arginine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in asparagine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in citrulline
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in cystine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in glutamate
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
|
Total plasma amino acids following overnight fasting
|
Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in glutamine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in glycine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
|
Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in histidine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in isoleucine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in leucine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in lysine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in methionine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in proline
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in ornithine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in phenylalanine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
|
Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in serine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
|
Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in taurine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in threonine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in tryptophan
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
|
Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in tyrosine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in valine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Total plasma amino acids following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in renal biomarkers: Serum cystatin C
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Blood sample following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in renal biomarkers: Serum creatinine
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Blood sample following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in renal biomarkers: Blood urea nitrogen
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Blood sample following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Adiponectin
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting.
An anti-inflammatory marker and related with both adipose tissue and insulin sensitivity
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in C-reactive protein (high sensitivity measurement)
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Serum myeloid-related protein
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Soluble Interleukin 2 Receptor
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in Inflammatory cytokine panel
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in oxidative stress: White cells glutathione (GSH)
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in oxidative stress: Plasma thiobarbituric acid-reactive species (TBAR)
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in oxidative stress:Total antioxidant reactivity (TAR)
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Following overnight fasting
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5).
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Change in patient opinion of acceptability of the product
Time Frame: Days 84 (visit 3) and 196 (visit 5)
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Product acceptability Likert scale:
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Days 84 (visit 3) and 196 (visit 5)
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Change in hunger
Time Frame: Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5)
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Measuring hunger in primary school children Likert scale:
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Days 0 (visit 2), 84 (visit 3), 112 (visit 4) and 196 (visit 5)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anita MacDonald, Birmingham Women's and Children's NHS Foundation Trust
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCT-CGMP-2017-05-23
- 239520 (Other Identifier: IRAS)
- 19/NW/0032 (Other Identifier: HRA)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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