Hospital Sant Joan de Deu
Barcelona, 08950, Spain
NCT Number: NCT04633044
Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Our previous results in humans demonstrate that lower breast milk betaine levels were associated with faster infant postnatal growth, a strong and potentially modifiable risk factor of future obesity. Betaine is a trimethylated derivative of glycine, which is present in multiple foods and occurs naturally in breast milk. In this study, we will perform a double-blind randomized placebo-controlled pilot clinical study, in which maternal diet will be supplemented with betaine for 3 months during breastfeeding; infant's growth and adiposity will be monitored until 12 months of age, and breast milk composition and gut microbiota analyzed. An additional follow-up visit will be conducted at 48 months of age to repeat microbiome analysis, determine adiposity, and perform cognitive development assessment.
This study is active but is not currently recruiting participants.
Notify Me20 year–42 year
Female
Interventional
Phase 1 / Phase 2
Barcelona, 08950, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
Time frame: Birth and 1 month
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 3 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 6 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 12 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: Birth and 48 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Time frame: 3, 12 and 48 months
Total body and abdominal fat mass measured by DXA scan
Time frame: 1 and 3 months
We will quantify betaine and related metabolites in maternal breast milk samples
Time frame: 1 and 3 months
We will quantify betaine and related metabolites in maternal plasma samples
Time frame: 1, 3, and 6, and 12 months
We will quantify betaine and related metabolites in infant urine samples
Time frame: 1, 3, 6, 12 and 48 months
DNA from infant fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Time frame: 1 and 3 months
DNA from maternal fecal samples will be sequenced to quantify abundance of the different bacterial groups.
Time frame: 1 and 3 months
DNA from breast milk samples will be sequenced to quantify abundance of the different bacterial groups.
Time frame: 1 and 3 months
Liquid chromatography coupled to mass spectrometry will be used to obtain a comprehensive metabolic profile of breast milk samples
Time frame: 1, 3, 6, and 12 months
Developmental progress will be evaluated with the parental reported ASQ-3 questionnaires
Time frame: 48 months
Respondents: Parents/caregivers
This evaluation is used to assist in the diagnosis of intellectual and developmental disabilities and measure the adaptive behaviors of individuals.
9 subdomains 3 domains and a overall ABCa. Motor Skills (77). Maladaptive Behavior (44) items. Total 502 items.
The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior (optional). The domain scores yield an adaptive behavior composite.
A scaled score typically tells us how well a child did on a specific sub-test, and a standard score typically tells us how well a child did on a broad domain (which is often made of sub-tests). Scaled Scores have a score range of 0 - 19 points, with an average score of 10 points.
Time frame: 48 months
Respondents: Parents/teachers. Information about a child's behaviour that is directly relevant to an understanding of that child's executive functioning.
63 items that measure various aspects of executive functioning: Inhibit, Shift, Emotional Control, Working Memory, and Plan/Organize.
A Likert-type scale with "never," "sometimes," and "often" options for rating behavior. The raw scores for the clinical scales and composite indexes are converted into standardized T-scores.
Higher scores on BRIEF-P clinical scales and composite indexes indicate greater difficulties with executive functions, while lower scores suggest fewer problems. Interpretation should consider clinical norms and the overall profile to assess the significance of the child's performance.
Time frame: 48 months
Respondents: childs, in direct interaction with the examiner. Is an individually administered, standardized assessment designed to evaluate the intelligence of young children.
The age range of the WPPSI-IV is divided into two age bands, ages 2:6-3:11 and ages 4:0-7:7.
WPPSI-IV (ages 2:6-3:11) can be interpreted at three levels: FSIQ (Full Scale Quotient), Primary Indexes (VCI=Verbal Comprehension Index, VSI=Visual Spatial Index, WMI=Working Memory Index), and Ancillary Indexes (VAI=Verbal Acquisition Index, NVI=Nonverbal Index, GAI=General Ability Index).
WPPSI-IV scores can be calculated manually or via software. Subtest raw scores convert to scaled scores (M=10, SD=3), which sum into composite scores (M=100, SD=15, e.g., FSIQ). Age-based percentiles are available. Practitioners can analyze discrepancies between composites and identify cognitive strengths and weaknesses.
Higher scaled or composite scores indicate better performance on that subtest or domain.
Time frame: 48 months
Respondents: Childs.
Age range: 2:0-99:11.
Copying geometric figures of increasing complexity to assess visual-motor integration. Helps assess the extent to which individuals can integrate their visual and motor abilities.
Poor performance on the Beery VMI is associated with difficulties in spatial organization of written text and maths. Some studies propose a cut-off below the 25th percentile to identify below-average motor performance. This treshold is higher than the 15th and 16th percentile cut-offs used in research to indicate severe difficulties with motor coordination affecting daily life.
Raw scores on the Beery VMI can range from 1 to 27, with a higher score reflecting a better performance. Raw scores can be converted into norm scores, which are adjusted for age.
Fundació Sant Joan de Déu
Other
Acronym: BetMilk
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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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