# Supplemental Evidence and Data Request on Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events
**AGENCY:**
Agency for Healthcare Research and Quality (AHRQ), HHS.
**ACTION:**
Request for supplemental evidence and data submission.
**SUMMARY:**
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on *Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events,* which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
**DATES:**
*Submission Deadline* on or before December 26, 2024.
**ADDRESSES:**
*Email submissions: [email protected]* .
*Print submissions:*
*Mailing Address:* Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
*Shipping Address (FedEx, UPS, etc.):* Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857.
**FOR FURTHER INFORMATION CONTACT:**
Kelly Carper, Telephone: 301-427-1656 or Email: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for *Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events.* AHRQ is conducting this review pursuant to section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( *e.g.,* details of studies conducted). We are looking for studies that report on *Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events.* The entire research protocol is available online at: *https://effectivehealthcare.ahrq.gov/products/saturated-fat-replacement/protocol* .
This is to notify the public that the EPC Program would find the following information on *Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events* helpful:
A list of completed studies that your organization has sponsored for this topic. In the list, please *indicate whether results are available on ClinicalTrials.gov* along with the *ClinicalTrials.gov trial number.*
*For completed studies that do not have results on ClinicalTrials.gov,* a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.
*A list of ongoing studies that your organization has sponsored for this topic.* In the list, please provide the *ClinicalTrials.gov * trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.
Description of whether the above studies constitute *ALL Phase II and above clinical trials* sponsored by your organization for this topic and an index outlining the relevant information in each submitted file.
Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: *https://effectivehealthcare.ahrq.gov/email-updates.*
The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.
**Key Questions (KQ)**
*KQ 1:* What are the effects of replacing dietary intake of total or individual saturated fatty acids with unsaturated, mono-unsaturated or polyunsaturated fatty acids, carbohydrates, or protein on plasma lipid concentrations in the general population?
*KQ 2:* What are the effects of replacing dietary intake of total or individual saturated fatty acids with unsaturated, mono-unsaturated or polyunsaturated fatty acids, carbohydrates, or protein on cardiovascular events in the general population?
| Element | Inclusion criteria | Exclusion criteria |
| --- | --- | --- |
| Population | Both Key Questions | Both Key Questions |
| | General population, without CVD, with or without modifiable CV risk factors, including | • Participants with a health-related condition or taking medications that impact fat absorption, fat metabolism. |
| Interventions | Both Key Questions | Both Key Questions |
| | • Diets with a lower intake of total saturated fatty acids | • Studies that do not quantify fatty acid intake as either g/day or % of total energy intake from saturated fat. |
| | Key Question 1 | |
| Comparators | Both Key Questions | Both Key Questions |
| | • Diets with no exchange and, thus, a higher intake of total saturated fatty acids, individual saturated fatty acids, or combination of saturated fatty acids | Diets with a caloric intake that are significantly higher or lower than the intervention/exposure diet. |
| Outcomes | Key Question 1 | Key Question 1 |
| | • Plasma lipoprotein concentrations | • Total cholesterol (TC). |
| | Key Question 2 | Key Question 2 |
| Subgroups/effect modifiers of interest | Both Key Questions | None. |
| | ○ Specific life stages | |
| | • Other characteristics | |
| Design | Key Question 1 | Both Key Questions |
| | • Studies of adults | • Observational studies that do not account for confounders. |
| | Key Question 2 | |
| Timing | Key Question 1 | None. |
| | • Minimum intervention length: 4 weeks | |
| Setting | • General community settings, including nursing homes, assisted living facilities, etc | • Hospital or other acute care settings. |
| Publication | • English language | |
Dated: November 19, 2024.
Marquita Cullom,
Associate Director.