Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2020-01-23
2021-11-30
Brief Summary
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Detailed Description
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The study is a balanced incomplete crossover design. Participants (children between 8 and 12 years old) have to be two periods of two days in the study. They will be randomized in 6 arms, receiving either water, 1 serving of a small breakfast (Breakfast 1) or 2 servings of the small breakfast (Breakfast 2).
An Interim Analysis after 9 completed subjects will be performed in order to calculate the total number of subjects needed to adequately power the Primary Endpoint.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Breakfast 1 - Breakfast 2
Participants will receive Breakfast 1 then Breakfast 2.
Breakfast 1
Participant will receive Breakfast 1
Breakfast 2
Participant will receive Breakfast 2
Breakfast 1 - water
Participants will receive Breakfast 1, then water.
Breakfast 1
Participant will receive Breakfast 1
Water
Participant will receive water
Breakfast 2 - water
Participants will receive Breakfast 2, then water.
Breakfast 2
Participant will receive Breakfast 2
Water
Participant will receive water
Breakfast 2 - Breakfast 1
Participants will receive 2 servings, then 1 serving of the study product.
Breakfast 1
Participant will receive Breakfast 1
Breakfast 2
Participant will receive Breakfast 2
Water - Breakfast 1
Participants will receive water, then Breakfast 1.
Breakfast 1
Participant will receive Breakfast 1
Water
Participant will receive water
Water - Breakfast 2
Participants will receive water, then Breakfast 2.
Breakfast 2
Participant will receive Breakfast 2
Water
Participant will receive water
Interventions
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Breakfast 1
Participant will receive Breakfast 1
Breakfast 2
Participant will receive Breakfast 2
Water
Participant will receive water
Eligibility Criteria
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Inclusion Criteria
2. Clinically healthy body weight (5 to 85th rounded percentile from UK)
3. In good health as determined by health screening questionnaires
4. English proficiency as per investigator judgment
5. Informed consent signed by parent(s), or legal representative if applicable and signed child assent according to local legislation
Exclusion Criteria
2. Any type of self-reported food allergies
3. Lactose intolerance
4. Claustrophobic
5. Diagnosis of Diabetes Mellitus
6. Diagnosed acute or chronic medical conditions that could impact study outcomes (asthma)
7. Ongoing diseases or intake of any prescribed or over the counter drugs
8. Participants or participants' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol (including a consumption of 200 ml study drink)
9. Currently participating or having participated in another clinical trial within 12 weeks prior to trial start.
8 Years
12 Years
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Liz Simpson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham Medical School
Locations
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University of Nottingham Medical School
Nottingham, , United Kingdom
Countries
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References
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Horstman AM, Bawden SJ, Spicer A, Darwish N, Goyer A, Egli L, Rupp N, Minehira K, Gowland P, Breuille D, Macdonald IA, Simpson EJ. Liver glycogen stores via 13C magnetic resonance spectroscopy in healthy children: randomized, controlled study. Am J Clin Nutr. 2023 Apr;117(4):709-716. doi: 10.1016/j.ajcnut.2023.01.014. Epub 2023 Jan 20.
Other Identifiers
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1906NRC
Identifier Type: -
Identifier Source: org_study_id
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