Maternal HealthFFNCT06748313
Fermented Food - Achars (fermented Pickles) in Pakistan
A study testing Mango Pickle (Water-Based), Mango Pickle (Oil Based) and Carrot Pickle (Water-Based) in people with Maternal Health and Gut Health, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Gut Health
- What is being tested?
- Mango Pickle (Water-Based), Mango Pickle (Oil Based) and Carrot Pickle (Water-Based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Dec 2021to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of reproductive age group (18-49 years) residing in the study area and should provide informed consent for study participation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mother and Child Health Research and Training Center
Matiari, Sindh, 71000
About this study
Official title: Grand Challenges Fermented Food - Achars (fermented Pickles) in Pakistan
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.
Read the 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
- Being tested
- Mango Pickle (Water-Based), Mango Pickle (Oil Based), Carrot Pickle (Water-Based), Radish Pickle (Water-Based), Onion Pickle (Water-Based)
- Keywords
- women of reproductive age, pregnant women, malnourished children, pakistan, microbiome, Fermented Foods, Fermented Achar, Fermented Pickle, Fermented Pickle - Achar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mango Pickle (Water-Based)Other
Also called Mango Achar
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.
Mango Pickle (Oil Based)Other
Also called Mango Achar
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.
Carrot Pickle (Water-Based)Other
Also called Carrot Achar
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.
Radish Pickle (Water-Based)Other
Also called Radish Achar
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.
Onion Pickle (Water-Based)Other
Also called Onion Achar
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.
Lemon & Chili Pickle (Water-Based)Other
Also called Lemon Achar
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.
| Study group | Role | What they receive |
|---|---|---|
| G1= Mango Pickle (Water-Based) | Experimental | This group will use 50 grams of Mango Pickle (Water-Based) daily as an intervention. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool inflammatory biomarkers
Change from baseline in myeloperoxidase (MPO)and lipocalin (LCN-2) at 8 weeks measured using ELISA in ng/ml
Measured: Baseline and 8 weeks
Secondary outcomes (2)
C-reactive protein (CRP)
Change from baseline in CRP (mg/ml) at 8 weeks measured using an automated analyzer
Measured: Baseline and 8 weeks
Microbiota composition
Change from baseline in 16S rRNA (alpha and beta diversity indices) enumeration at 8 and 12 weeks, determined using Illumina-based sequencing
Measured: Baseline and 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start29 Dec 2021
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Minnesota
- Responsible party
- Principal investigator, Dr Syed Asad Ali, Aga Khan University
- Investigators
- Asad Ali, MPH, Principal investigator, Aga Khan University Hospital, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748313
- Sponsor's protocol ID
- 51952
- Acronym
- FF
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grand Challenges Fermented Food - Achars (fermented Pickles) in Pakistan
- ClinicalTrials.gov ID
- NCT06748313
- Acronym / sponsor ID
- FF / 51952
- Conditions
- Maternal Health, Gut Health
- Keywords
- women of reproductive age, pregnant women, malnourished children, pakistan, microbiome, Fermented Foods, Fermented Achar, Fermented Pickle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Minnesota
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| G1= Mango Pickle (Water-Based) | Experimental | Other: Mango Pickle (Water-Based)This group will use 50 grams of Mango Pickle (Water-Based) daily as an intervention. |
| G2= Mango Pickle (Oil Based) | Experimental | Other: Mango Pickle (Oil Based)This group will use 50 grams of Mango Pickle (oil-based) daily as an intervention. |
| G3= Carrot Pickle (Water-Based) | Experimental | Other: Carrot Pickle (Water-Based)This group will use 50 grams of Carrot Pickle (Water-Based) daily as an intervention. |
| G4= Radish Pickle (Water-Based) | Experimental | Other: Radish Pickle (Water-Based)This group will use 50 grams of Radish Pickle (Water-Based) daily as an intervention. |
| G5= Onion Pickle (Water-Based) | Experimental | Other: Onion Pickle (Water-Based)This group will use 50 grams of Onion Pickle (Water-Based) daily as an intervention. |
| G6= Lemon & Chili Pickle (Water-Based) | Experimental | Other: Lemon & Chili Pickle (Water-Based)This group will use 50 grams of Lemon \& Chili Pickle (Water-Based) daily as an intervention. |
| Control (non-fermented vegetables or fruits) | No intervention | –This group will serve as "Control" (non-fermented vegetables or fruits). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women of reproductive age group (18-49 years) residing in the study area and should provide informed consent for study participation.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mango Pickle (Water-Based)Also: Mango AcharThe 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. | Other | G1= Mango Pickle (Water-Based) |
| Mango Pickle (Oil Based)Also: Mango AcharThe 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. | Other | G2= Mango Pickle (Oil Based) |
| Carrot Pickle (Water-Based)Also: Carrot AcharThe 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. | Other | G3= Carrot Pickle (Water-Based) |
| Radish Pickle (Water-Based)Also: Radish AcharThe 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. | Other | G4= Radish Pickle (Water-Based) |
| Onion Pickle (Water-Based)Also: Onion AcharThe 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. | Other | G5= Onion Pickle (Water-Based) |
| Lemon & Chili Pickle (Water-Based)Also: Lemon AcharThe 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. | Other | G6= Lemon & Chili Pickle (Water-Based) |
Primary outcome
Stool inflammatory biomarkers
Time frame: Baseline and 8 weeks
Change from baseline in myeloperoxidase (MPO)and lipocalin (LCN-2) at 8 weeks measured using ELISA in ng/ml
2 secondary outcomes
C-reactive protein (CRP)
Time frame: Baseline and 8 weeks
Microbiota composition
Time frame: Baseline and 8 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Yes. De-identified individual data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asad Ali, MPH principal investigator
Aga Khan University Hospital, Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mango Pickle (Water-Based), Mango Pickle (Oil Based) and Carrot Pickle (Water-Based) in people with Maternal Health and Gut Health, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool inflammatory biomarkers (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.