Fermented Food - Achars (fermented Pickles) in Pakistan

NCT06748313 | Completed DMC

• 1 other identifier: 51952
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

The highest burden of malnutrition in the world is in South Asia and Africa. Over the last ten years, our work on Environmental Enteric Dysfunction in Matiari, a poor rural district in the Sind province of Pakistan, shows that the most critical driver of childhood stunting is anthropometry at birth. Birth anthropometry is primarily influenced by maternal health and nutrition. Fermented foods are an indigenous yet underutilized resource that could improve gut health, reduce inflammation, and promote a healthy microbiome in women. The most common plant-based fermented food used in rural Sind is the achar, a local variety of fermented pickles made from many different vegetables and fruits. Achar has been used over centuries in this area. Traditional folklore dictates that achar is good for pregnancy. Craving for achar is a sign of early pregnancy in this culture. Achars are considered antiemetics and are believed to help relieve gastric issues in early pregnancy. The medical benefits of pickles/achars are fairly well recognized. Major microbes involved in the fermentation of Achar are LAB (Lactic Acid Bacteria), bacillus, and micrococcus species, which are directly or indirectly responsible for multiple health benefits. However, a clinical trial has not been conducted to determine the impact of regular use of achar on the health of women of childbearing age in a real-life setting. The investigator hypothesizes that traditional, fermented achar use reduces gut and systemic inflammation and drives a healthy microbiome in women of reproductive age in Matiari, rural Sindh, Pakistan. If our trial confirms this hypothesis, then at-scale use of the best achars can be advocated in this community as an Indigenous and culturally appropriate intervention.

Conditions

Maternal Health; Gut Health

Keywords

women of reproductive age; pregnant women; malnourished children; pakistan; microbiome; Fermented Foods; Fermented Achar; Fermented Pickle; Fermented Pickle - Achar

Outcome Measures

Primary Outcomes (1)

• Stool inflammatory biomarkers

  Change from baseline in myeloperoxidase (MPO)and lipocalin (LCN-2) at 8 weeks measured using ELISA in ng/ml

  Baseline and 8 weeks

Secondary Outcomes (2)

• C-reactive protein (CRP)

  Baseline and 8 weeks

• Microbiota composition

  Baseline and 8 and 12 weeks

Study Arms (7)

G1= Mango Pickle (Water-Based)

EXPERIMENTAL

This group will use 50 grams of Mango Pickle (Water-Based) daily as an intervention.

Other: Mango Pickle (Water-Based)

G2= Mango Pickle (Oil Based)

EXPERIMENTAL

This group will use 50 grams of Mango Pickle (oil-based) daily as an intervention.

Other: Mango Pickle (Oil Based)

G3= Carrot Pickle (Water-Based)

EXPERIMENTAL

This group will use 50 grams of Carrot Pickle (Water-Based) daily as an intervention.

Other: Carrot Pickle (Water-Based)

G4= Radish Pickle (Water-Based)

EXPERIMENTAL

This group will use 50 grams of Radish Pickle (Water-Based) daily as an intervention.

Other: Radish Pickle (Water-Based)

G5= Onion Pickle (Water-Based)

EXPERIMENTAL

This group will use 50 grams of Onion Pickle (Water-Based) daily as an intervention.

Other: Onion Pickle (Water-Based)

G6= Lemon & Chili Pickle (Water-Based)

EXPERIMENTAL

This group will use 50 grams of Lemon \& Chili Pickle (Water-Based) daily as an intervention.

Other: Lemon & Chili Pickle (Water-Based)

Control (non-fermented vegetables or fruits)

NO INTERVENTION

This group will serve as "Control" (non-fermented vegetables or fruits).

Interventions

Mango Pickle (Water-Based) OTHER

The ingredients used in Mango Pickle (Water-based) are Raw mangoes, Carrots, Lemon, Green chili, Gum Berry (Lasora), Grewia asiatica (Phalsa), Sea salt, Fenugreek seeds whole, Fenugreek mashed, Fennel seeds, Chili flakes, Coriander seeds, Turmeric powder, Cumin, Black seeds, Bay leaves, Mashed garlic, Mustard oil, Vinegar, and Water. The pickle's fermentation process will be completed in 6-7 days, and it will be ready to use.

Also known as: Mango Achar

G1= Mango Pickle (Water-Based)

Mango Pickle (Oil Based) OTHER

The ingredients used in Mango Pickle (Oil-based) are Raw mangoes, Carrots, Lemon, Green chili, Gum Berry (Lasora), Grewia asiatica (Phalsa), Sea salt, Fenugreek seeds whole, Fenugreek mashed, Fennel seeds, Chili flakes, Coriander seeds, Turmeric powder, Cumin, Black seeds, Bay leaves, Vinegar, Mashed garlic, and Mustard oil. The pickle's fermentation process will be completed in 6-7 days, and it will be ready to use.

Also known as: Mango Achar

G2= Mango Pickle (Oil Based)

Carrot Pickle (Water-Based) OTHER

The ingredients used in Carrot Pickle (Water-Based) are Carrots, Spring garlic, Turmeric, water, mashed mustard seeds, chili powder, salt, and Mustard oil. The pickle's fermentation process will be completed in 2-3 days, and it will be ready to use.

Also known as: Carrot Achar

G3= Carrot Pickle (Water-Based)

Radish Pickle (Water-Based) OTHER

The ingredients used in Radish Pickle (Water-Based) are Radish, Spring garlic, Turmeric, water, mashed mustard seeds, chili powder, salt, and Mustard oil. The pickle's fermentation process will be completed in 2-3 days, and it will be ready to use.

Also known as: Radish Achar

G4= Radish Pickle (Water-Based)

Onion Pickle (Water-Based) OTHER

The ingredients used in Onion Pickle (Water-Based) are Onion, Vinegar, Turmeric, water, mashed mustard seeds, chili powder, salt, and Mustard oil. The pickle's fermentation process will be completed in 3-4 days, and it will be ready to use.

Also known as: Onion Achar

G5= Onion Pickle (Water-Based)

Lemon & Chili Pickle (Water-Based) OTHER

The ingredients used in Lemon \& Chili Pickle (Water-Based) are Lemon, Green Chili, Turmeric, Vinegar, water, and salt. The pickle's fermentation process will be completed in 2-3 days, and it will be ready to use.

Also known as: Lemon Achar

G6= Lemon & Chili Pickle (Water-Based)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women of reproductive age group (18-49 years) residing in the study area and should provide informed consent for study participation.

You may not qualify if:

• Antibiotics or probiotics or laxatives use in the past two weeks.
• Current diarrheal illness.
• Regular (\>= two times a week) use of achars before enrollment.
• Any Gastrointestinal illness such as chronic constipation, Irritable bowel syndrome, Gastroesophageal Reflux Disease (GERD), peptic ulcer disease, Gluten Sensitivity and Celiac Disease, Inflammatory Bowel Disease, or history of laparoscopic surgery in GI tract or cholecystectomy.
• Known case of hypertension.

Sponsors & Collaborators

• Aga Khan University: lead
• Bill and Melinda Gates Foundation: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Mother and Child Health Research and Training Center

Matiari, Sindh, 71000, Pakistan

Location

Study Officials

• Asad Ali, MPH

  Aga Khan University Hospital, Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 27, 2024
• Study Start: December 29, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 24 months of study completion
• Access Criteria: The Trial Management Group will review data access requests. Requestors will be required to sign a Data Access Agreement.

Locations

PA (1)