The goal of this study is to demonstrate that babies fed Jovie goat formula grow at the same rate as those fed a commercially available cow milk formula. Such a study is a requirement by the FDA to allow a new infant formula to the USA market. The study also includes a group of breastfed babies.
Parents around the globe who formula feed their babies have an increasing preference for goat milk-based infant formula. In Europe, as well as many other countries, goat milk has long been accepted by local authorities as a suitable protein source in infant formula. The FDA requires all new infant formulas to undergo a growth monitoring study before being sold in the United States. No goat milk infant formula has been reviewed by the FDA yet; thus such a formula is not available in the USA.
Our study formula is made in the USA by a manufacturer with considerable experience in the manufacturing of similar products. All our nutrients comply with FDA infant formula requirements. Our study complies with all FDA guidelines and all ethical requirements as outlined by an independent Institutional Review Board (IRB) for such studies.
Click HERE to complete the pre-screening questionnaire and see if you qualify to participate. If you and your baby qualify, you will receive an email confirming eligibility. The email contains your participant ID and a link where you can download the study app. Then just follow the steps in the app. You can reach out to the study team through the chat function within the app.
The study takes up to 18 weeks, including enrollment and training. Once you have registered and have been trained to perform the weight, length, and head circumference measurements at home, you will be asked to repeat these measurements on 6 occasions over the course of the 16 weeks. You will enter the measurements and some additional information in the study app so we can track your baby’s growth.
The total compensation for completing the study is $450 spread out over eight payments. Payments are made when study milestones are met for completing tasks over time such as study training, completing surveys and measurements, and providing stool samples.
While there are risks associated with any research study, there are minimal to no risks to participation in this study. All ingredients in the goat milk infant formula have substantial evidence of safety, and the manufacturer has considerable experience with the manufacturing of similar products. The cow milk formula used in this study is available in USA stores and also has substantial evidence of safety.
The risks in this study are outlined in the informed consent form which you will review, and you will be able to ask the study team/doctor any questions, before signing prior to starting participation in this study.
You will be provided with video training on formula preparation and measurement techniques. Your baby’s study data will be closely monitored by the study team/doctor, and support is available to you at any time.
Infants with a family history (parents or siblings) of confirmed milk or soy allergies cannot participate in this study. If your baby has a cow milk protein allergy or lactose intolerance, they are not eligible to join our study.
No, the entire study will be performed online and in-home with the support of the app and the study team (study physician, nurses, and coordinators) operating remotely.
Congratulations! Yes, you can enroll in our study starting at your 35th week of pregnancy. You will be reminded about our study when your due date is getting closer.
Yes, you can. As our study also includes a group of babies that will be exclusively breastfed during the period of the study (16 weeks), please click HERE to check if you are eligible to join the breastfed group of our study. You will not be asked to use any formula or change your feeding plans in any way to participate in the study.
Once you have received all measuring devices at home, you will be trained during a live video call with one of our nurses on how to correctly perform weight, length and head circumference measurements on your baby. Our nurse will guide you through the process. Once trained, the nurse will monitor your measurements via this live video call. Video monitoring will also take place with at least 2 of your follow-up measurements. If needed or desired, we will guide you through the study at additional follow-up time points as well.
Be aware that you will need an extra pair of hands to perform some of the measurements accurately.
Our team will monitor your baby’s development based on the measurements that you enter. In case the development is different than expected, the team will engage our study doctor and you may be contacted.
Your pediatrician will continue to see your infant as they normally would. Your pediatrician will advise you on your baby’s feeding schedule. If your pediatrician would like to know more about our study, they can check out this website or contact us at email@example.com for more details.
No. Using the smartphone or tablet you already own, everything required to participate in the study, such as the app, the measuring devices, and the formula (for babies in the formula-only groups), will be provided at no cost. We only need some of your time, for which you will be compensated.
Participation in this study is entirely voluntary and can be stopped at any time. If you consider stopping, please contact us first. As your participation is so important to us, we would like to have a chance to see if we can help you.
No, you do not need insurance for this study other than the insurance you may already have.
This study is sponsored by Jovie USA in partnership with IQVIA Consumer Health and ObvioHealth, a leader in consumer virtual scientific research. The study complies with the FDA and IRB regulations for clinical best practice. Our study is all about online and in-home participation. As this study is virtual, we can imagine you would like to know more about our team. Feel free to visit JovieUSA.com and ObvioHealth.com to meet our teams. Feel free to contact us at firstname.lastname@example.org and we will be happy to answer your questions.
Traditionally, infant formulas are based on cow milk. In the past two decades, goat milk-based infant formulas have appeared on the global market. Growing numbers of parents around the globe have experienced the benefits of goat milk-based infant formula and have learned to appreciate it. Many of them enjoy the easy digestibility of goat milk and find that their babies are responding very well to goat milk infant formula.
Switching to one of the study formulas is not a problem. All formulas sold in the USA meet the same strict FDA nutritional requirements as detailed in federal regulations, so you need not worry. You can always consult your pediatrician before making your decision.
Once you register for the study, and you have been accepted, we will make sure you receive the first batch of formula promptly (typically within two days). This shipment also includes all measuring devices to start your participation. Thereafter, you will receive additional infant formula 2 times to make sure you always have enough product throughout the study period. You may keep any remaining formula that you received for the study.
No, all formula-fed babies in the study have a 50/50 chance of receiving either the goat milk infant formula or the cow milk infant formula. This is totally random, which is a requirement for the study, so that the interpretation of the growth measurements is not influenced by the research team knowing which formula your baby received. Selecting one formula over the other is not possible.
If your baby is selected for the cow milk formula group, you will receive Costco’s Kirkland Signature infant formula.
Yes, both formulas meet the same strict FDA nutritional requirements as detailed in Federal regulations, so you need not worry. We closely monitor your baby’s growth; however, this study does not replace your regular visits to your pediatrician.
Yes, European and other international authorities have thoroughly reviewed the nutritional content of goat's milk. They've found that, when adapted for baby formula, goat's milk protein supports normal growth and development in infants. Some people believe that it may be tolerated better than formula based on cow milk or soy protein, with less upset stomachs or allergic responses, but that's not certain. However, raw goat's milk, like raw cow's milk, is not safe to feed a baby. Refer to this article found on the American Academy of Pediatrics website.
If you have any questions, then please contact the study team on email@example.com
If you think the formula does not agree with your baby, we recommend you contact our study team to discuss your concerns and our study doctor will get in touch with you. In medical emergencies you should contact your own physician.
The sponsor of this study is Jovie USA and is part of an international group headquartered in Europe (the Netherlands). The Jovie brand was created by passionate professionals in infant formula with a long history and love of goat milk. They decided to start a new company in 2017, as they wanted to develop an even better goat milk formula.
Jovie formula is currently available in Europe and the Middle East. The Jovie team wants to bring the first goat milk infant formula to the USA market, manufactured in the USA. The infant formula in the study is a whole goat milk-based product, free from GMOs, palm oil and other undesirable ingredients.
The FDA requires all new infant formulas to undergo a growth monitoring study before they can be sold in the United States. In Europe, as well as many other countries, goat milk has already been accepted by local authorities as a suitable protein source in infant formula since 2012. Our study formula is made in the USA, in an FDA-compliant facility. All nutrients comply with FDA infant formula requirements. This study aims to make goat milk infant formula also available to parents and babies in the USA.
Jovie is new to the USA market, but not a new company or brand internationally. It was established in 2017 by a group of passionate professionals in infant formula with a long history in goat milk. Jovie products have been in the international market for years.
The Jovie product is made in the USA in a state-of-the-art formula manufacturing facility.
Yes, it does. All infant formulas must meet the strict FDA nutritional requirements as specified by federal regulations, so you need not worry. This study is approved by the Institutional Review Board (IRB) and listed on clinicaltrials.gov
This goat milk formula study is IRB approved and listed on http://clinicaltrials.gov
We take COVID-19 and your safety seriously: you can participate in this study completely from home.
Sponsored by Jovie USA LLC
Contact info (firstname.lastname@example.org)
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