Fermented Food - Achars (fermented Pickles) in Pakistan

NCT ID: NCT06748313

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-29
• Study Completion Date: 2022-10-10

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.

Detailed Description

The investigator recruited 210 women of reproductive age (18-45 years), including pregnant women. These women were divided into seven groups. Six groups were randomly assigned as "Test," and one group served as "Control" (non-fermented vegetables or fruits). Different formulations of achar were assigned to each of the groups.

G1= Mango Pickle (Water-Based) G2= Mango Pickle (Oil Based) G3= Carrot Pickle (Water-Based) G4= Radish Pickle (Water-Based) G5= Onion Pickle (Water-Based) G6= Lemon & Chili Pickle (Water-Based)

Women were recruited from the community through a demographic surveillance system established in Matiari, Pakistan. The study staff approached and introduced the potential participants to this study. If Participants agree, After informed consent, a short questionnaire was filled out, including information about socio-demographics, household food insecurity index, history of illness, and anthropometric measurements. 10ml blood samples were collected at baseline and at 8 weeks. 5ml blood sample was used for CBC and cytokine measurement while 5ml blood was required to collect PBMCs which was used for Transcriptomics analyses as complete immune-profiling is necessary to study the microbiome-host interaction and its impact on immune cells. Fecal samples were collected longitudinally for biomarkers assessment and fecal microbiome at baseline, at 8 weeks, and then at 12 weeks. A 24-hour food recall form was filled out at enrollment and at 8 weeks. We delivered pickles to the intervention group. The investigator did not offer anything for the control group. However, control participants were requested to eat non-fermented food and avoid fermented foods. The investigator collected information about compliance with treatment (Test group) after every 14 days. Common food items consumed in the last 7 days were collected through the food frequency form at each follow-up. Participants in intervention groups were given pickles in 50 gms of pre-weighted cups/jars for daily consumption, and partially eaten pickle cups were weighed again at each follow-up to measure compliance and standardization of pickle intake. All jars will be bar-coded. The study team will ensure the refilling of pickles at the household level.

Conditions

Maternal Health; Gut Health

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

G1= Mango Pickle (Water-Based)

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

Group Type: EXPERIMENTAL

Mango Pickle (Water-Based)

Intervention Type: 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.

G2= Mango Pickle (Oil Based)

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

Group Type: EXPERIMENTAL

Mango Pickle (Oil Based)

Intervention Type: 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.

G3= Carrot Pickle (Water-Based)

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

Group Type: EXPERIMENTAL

Carrot Pickle (Water-Based)

Intervention Type: 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.

G4= Radish Pickle (Water-Based)

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

Group Type: EXPERIMENTAL

Radish Pickle (Water-Based)

Intervention Type: 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.

G5= Onion Pickle (Water-Based)

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

Group Type: EXPERIMENTAL

Onion Pickle (Water-Based)

Intervention Type: 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.

G6= Lemon & Chili Pickle (Water-Based)

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

Group Type: EXPERIMENTAL

Lemon & Chili Pickle (Water-Based)

Intervention Type: 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.

Control (non-fermented vegetables or fruits)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mango Pickle (Water-Based)

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.

Intervention Type: OTHER

Mango Pickle (Oil Based)

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.

Intervention Type: OTHER

Carrot Pickle (Water-Based)

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.

Intervention Type: OTHER

Radish Pickle (Water-Based)

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.

Intervention Type: OTHER

Onion Pickle (Water-Based)

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.

Intervention Type: OTHER

Lemon & Chili Pickle (Water-Based)

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.

Intervention Type: OTHER

Other Intervention Names

Mango Achar; Mango Achar; Carrot Achar; Radish Achar; Onion Achar; Lemon Achar

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr Syed Asad Ali

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asad Ali, MPH

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University Hospital, Karachi

Locations

Mother and Child Health Research and Training Center

Matiari, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

51952

Identifier Type: -

Identifier Source: org_study_id