Traditional Asian Diet and Gut Microbiome and Metabolome in Healthy Volunteers and Pregnancy on Infant's Allergy Development

NCT04885959 | Enrolling By Invitation DMC

• 1 other identifier: USM/JEPeM/20120611
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The research aims to elucidate a specially-designed personalized diet based on Traditional Asian Diet and its efficacy in increasing the gut colonization of Prevotella sp. and butyrate levels in pregnant mothers and the benefits in reducing infant's food allergy development.

Conditions

Pregnancy; Food Hypersensitivity; Healthy

Outcome Measures

Primary Outcomes (4)

• Maternal gut microbiome composition before and after intervention

  Maternal stool samples will be collected at three pre-determined intervals (baseline (week 16), week-28 and week-36 gestation. The gut microbiota composition will be examined using the 16s rRNA sequencing. The alpha (Shannon, Simpson and Evenness Indices) and beta diversity of the gut microbiota will be compared within and between groups.

  20 weeks

• Maternal stool metabolome concentration of short chain fatty acids (SCFA) before and after intervention

  Maternal stool samples will be collected at three pre-determined intervals (baseline (week 16), week-28 and week-36 gestation. The changes in stool SCFA concentration in (umol/g) will analyzed using the gas chromatography - mass spectrometry (GC-MS). The concentration (umol/g) be compared within and between groups.

  20 weeks

• Incidence of allergy development in the delivered infants and its correlation with maternal gut microbiome during pregnancy.

  Symptoms perceived by parents/caregivers will be asked during postnatal follow-ups at day day-28, 3, 6 and 12 months of age using a validated questionnaire, the Comprehensive Early Childhood Allergy Questionnaire (CECAQ) (Minasyan A. et al.,2015). The results are then correlated with the maternal gut microbiome composition during pregnancy which was first being examined through the 16S rRNA sequencing analysis.

  12 months

• Incidence of allergy development in the delivered infants and its correlation with maternal stool metabolome during pregnancy.

  Symptoms perceived by parents/caregivers will be asked during postnatal follow-ups at day day-28, 3, 6 and 12 months of age using a validated questionnaire, the Comprehensive Early Childhood Allergy Questionnaire (CECAQ) (Minasyan A. et al.,2015). The results are then correlated with the maternal gut microbiome composition during pregnancy which was first being examined through the 16S rRNA sequencing analysis.

  12 months

Secondary Outcomes (4)

• Infant's gut microbiome composition at neonatal age and its correlation with allergy development

  12 months

• Infant's stool metabolome of the short-chain fatty acids (SCFA) concentration during neonatal age and its correlation with allergy development

  12 months

• Infant's immune functions and allergy development

  12 months

• Infant's gut barrier and allergy development

  12 months

Other Outcomes (2)

• The changes on gut microbiome composition in healthy volunteers before and after 4 weeks dietary intervention.

  4 weeks

• The changes on stool metabolome of shiort chain fatty cids (SCFA) composition in healthy volunteers before and after 4 weeks dietary intervention.

  4 weeks

Study Arms (2)

Usual diet

NO INTERVENTION

In the pilot study among healthy volunteers, participant need to maintain their habitual diet for 4 weeks. Meanwhile, in the large-scale study among pregnant women, participants are subjected to receive general dietary advice for healthy pregnancy from attended nurses or physician during their antenatal visits.

Traditional Asian Diet

EXPERIMENTAL

Participants will receive dietary intervention on a traditional Asian diet which diet consists of high fiber, moderate protein, and low fat and with the inclusion of local probiotics and prebiotics food sources which are known to enhance gut health by fostering the gut colonization of beneficial bacteria and promoting the production of SCFA. During the pilot phase the diet is given for four weeks. Meanwhile, the intervention among pregnant mothers, the intervention is given for 20 weeks considering the nature of the availability of pregnant mothers being recruited where most of them (low risk pregnancy) were given their first clinic appointment at 16 weeks of gestational age.

Behavioral: Traditional Asian Diet

Interventions

Traditional Asian Diet BEHAVIORAL

The personalized traditional Asian diet will be formulated based on dietary components of a typical Asian diet characterized by high intake of fruits and vegetables, whole grains, legumes, nuts, seeds, soy foods and herbs and spices; moderate intake of fish, poultry, eggs, healthy cooking oils, yogurt or functional foods and low intake of meats and sweets (Ismail et al., 2020). The diet design also considering the recommendation of personalized dietary approach by including the element of individual preferences, requirement, cultural preferences, affordability and foods availability to facilitate the adherence and response to the diet.

Traditional Asian Diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Malaysian and of the Malay ethnicity
• Living in Kelantan for at least 5 years
• Age 18 to 40 years
• The lower limit of ≥16th weeks and the upper limit of \<20th week of gestation during enrollment to allow at least 20 weeks of dietary intervention prior to delivery. The gestational age was based on the last menstrual period (LMP) or early ultrasound examination
• Singleton pregnancy
• History of personal and family history of allergy (presence of reported or doctor-diagnosed allergic disease including asthma, eczema, food allergy, or allergy rhinitis) in participants, their partners or in their previous child or pregnancy.
• In attendance of antenatal clinic at Hospital USM or Klinik Kesihatan (Kota Bharu/Kubang Kerian/Pengkalan Chepa)
• Living area within 10 km radius of Kota Bharu, Kelantan
• Consent to participate

You may not qualify if:

• Significant present or having past medical history of chronic disease for example bowel, cancer disease, systemic lupus erythematosus (SLE), chronic kidney disease, heart failure, stroke, haematological malignancy, and chronic obstructive pulmonary disease.
• Significant psychiatric history including major depression and other psychotic disorders.
• Significant present or past surgical history including bowel surgeries
• Significant presence of doctor-diagnosed short intestinal bacteria overgrowth (SIBO).
• Taking any medications which may disturb the gut microbiota or intestinal function, for example, antibiotics for the past 3 months, immunosuppressive drugs, opiates, anticoagulants and etc.
• Those who plan to move out from Kelantan after delivery which may affect the follow-up.
• Those who follow a vegetarian diet will also be excluded from participating.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (1)

• Sahran NF, Chong CW, Ismail IH, Taib F, Hoo PS, Palanisamy UD, Sundralingam U, Teh CSJ, Kong ZX, Ayub Q, Yoke Ling F, Hazlan SNH, Azlan M, Abdul Razak S, Tengku Din TADA, Abdullah N, Tagiling N, Tee V, Ehab Ayad M, Zheng FM, El-Omar E, Lee YY. Effects of Traditional Asian Diet on dietary fibre requirement, gut microbiome composition, and faecal and urine metabolomes in healthy Asian women: a pilot study. Benef Microbes. 2025 Apr 22:1-14. doi: 10.1163/18762891-bja00074. Online ahead of print.

  PMID: 40312033 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• NUR-FAZIMAH SAHRAN

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: September 1, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)