During the active study period of up to six weeks, within a total participation window of up to 70 days, participants continue the easy runs, speed/quality sessions, and long runs already included in their normal endurance-training plan while following the selected study fueling condition for each session: SAP25 Maple Syrup Energy Gel/SAP Good Energy, an alternative gel chosen by the participant, or no gels. Participants link Strava to capture non-geographic training metrics and use two supplied Lingo CGM biosensors during two 14-day monitoring phases that may be consecutive or separated by a break of up to 14 days within the six-week active period.

• Onboarding: Complete Goals & Expectations, link Strava, and activate the first supplied Lingo CGM for the first 14-day phase. Activate the second supplied Lingo CGM for the second 14-day phase, either immediately afterward or after a break of up to 14 days.
• Each study run: Select a remaining condition for an easy run, speed/quality session, or long run already in your normal training plan, then follow that condition's fueling instructions.
• After every run: Complete the matching After Run Assessment immediately and within 24 hours to report session-level outcomes.

The study, “Learn what gels work for you and the impacts on blood glucose,” is a prospective, open-label, interventional, within-participant Signal Phase study designed to evaluate responses to different endurance fueling strategies during routine training. Participants serve as their own control by completing training sessions under three fueling conditions: SAP25 Maple Syrup Energy Gel, an alternative processed energy gel, and no gels. This design is intended to provide a directional indication of whether SAP-based fueling may be associated with favorable changes in perceived performance, gastrointestinal comfort, exertion, running metrics, and blood glucose dynamics compared with each participant’s own responses under the other conditions.

The study experience consists of an active study period of up to six weeks within a total participation window of up to 70 days, with tasks delivered through the Efforia platform. Participants continue workouts from their normal training plan, link Strava, use two supplied Lingo continuous glucose monitor biosensors during two 14-day monitoring phases that may be consecutive or separated by a break of up to 14 days within the six-week active period, complete study-designated easy runs, speed/quality sessions, and long runs under the specified fueling conditions, and submit an after-run assessment following each session. Key outcome measures include self-reported energy, gut comfort, and perceived effort; passively collected running metrics including pace, heart rate, and distance from Strava; and blood glucose measures from the continuous glucose monitor. These repeated measures allow comparison of physiologic and subjective responses within the same individual across different fueling exposures.

As an Efforia Signal Phase study, this protocol is not intended to provide definitive efficacy evidence, but rather to identify whether there is a positive signal suggesting that SAP25 Maple Syrup Energy Gel may improve training experience, fueling tolerance, performance-related measures, or glucose stability relative to alternative gel use or no gels. The study will also contribute safety and tolerability data, particularly regarding gastrointestinal comfort, perceived adverse effects, and any health concerns reported during the protocol, which are currently limited for this use case. If a positive signal is observed, more robust study designs, such as randomized controlled or crossover trials, may be considered. For additional procedural, safety, and oversight details, reviewers should refer to the Minimal Risk Umbrella protocol.

No fixed enrollment target is specified. Sample-size and statistical assumptions follow the applicable umbrella framework; this exploratory study is not powered to establish definitive efficacy or superiority.

Statistical Analysis Plan

This study is conducted under the Minimal Risk Umbrella protocol. The statistical approach for this activity is consistent with the statistical framework described in the Minimal Risk Umbrella protocol. Reviewers who wish to evaluate the full statistical plan, including general analytic assumptions, handling of repeated measures, missing data, and exploratory analyses, should review the statistical plan within the umbrella protocol.

Study Design

This is an exploratory, within-participant, repeated-measures comparison of three fueling conditions during endurance training:

1. SAP25 Maple Syrup Energy Gel
2. Processed energy gel
3. No Gels

Participants will complete two 14-day CGM phases within up to six weeks, including six long runs, six easy runs, and six speed sessions. Participants select among the remaining fueling conditions for each workout type within each phase. Outcomes will be collected after each run and through passive data capture from Strava and the Lingo CGM/App by Abbott.

Because each participant serves as their own control, analyses will focus primarily on within-person differences across fueling conditions.

Primary Outcomes

The primary outcomes are participant-reported post-run measures, including:

• Energy level
• Gut comfort / gastrointestinal tolerability
• Perceived effort

These session-level measures will be compared across the three fueling conditions within each participant and workout type. Assessments are collected after each study run, not as a fixed baseline-to-Day-42 endpoint. Carbohydrate amounts are not matched between SAP and the alternative gel; differences in dose and formulation are limitations of this real-world comparison.

Secondary and Exploratory Outcomes

Secondary and exploratory outcomes include:

• Strava-derived performance measures, such as pace, heart rate, distance, and maximum speed
• CGM-derived glucose measures, such as:
  • Peak glucose associated with a monitored study run
  • Glucose rise from the relevant session baseline, where available
  • Time to peak glucose
  • Return toward baseline
  • Overall glucose variability during and after exercise, where available

These outcomes are exploratory and are intended to help participants understand individual fueling responses, performance patterns, gut tolerability, and glucose response.

Analytic Approach

Analyses will be primarily descriptive and exploratory. Summary statistics will be calculated for each fueling condition overall and by workout type, including long runs, easy runs, and speed sessions.

For continuous outcomes, descriptive statistics may include:

• Mean
• Median
• Standard deviation
• Interquartile range
• Minimum and maximum values

For ordinal or rating-scale outcomes, results may be summarized using medians, interquartile ranges, and frequency distributions.

Where appropriate, within-participant comparisons may be conducted using paired analytic methods. These may include paired t-tests, Wilcoxon signed-rank tests, repeated-measures ANOVA, or linear mixed-effects models, depending on data distribution, sample size, and outcome type.

If mixed-effects models are used, models may include:

• Fixed effect for fueling condition
• Fixed effect for workout type
• Fixed effect for study week or session order, if needed
• Participant-level random intercepts to account for repeated measurements within individuals

Potential covariates may include run duration, distance, average heart rate, workout type, or other contextual variables if available and analytically appropriate.

Handling of Missing Data

Missing data may occur if participants miss runs, do not complete post-run ratings, have incomplete Strava synchronization, or experience CGM data gaps. Analyses will generally use available data without imputation unless otherwise specified in the umbrella protocol.

The extent of missingness will be summarized descriptively. Participants with partial data may still be included in analyses for outcomes and sessions with available data.

Multiple Comparisons

Because this is an exploratory minimal-risk study, analyses are not intended to provide definitive hypothesis testing or clinical claims. If multiple comparisons are conducted, findings will be interpreted cautiously. Adjustments for multiple comparisons may be applied where appropriate, but emphasis will be placed on effect sizes, confidence intervals, and individual response patterns rather than statistical significance alone.

Sample Size and Power

This protocol is exploratory and is not powered to establish definitive efficacy or superiority of one fueling condition over another. The purpose is to characterize individual and group-level patterns in perceived energy, gut comfort, effort, performance metrics, and glucose response across fueling conditions.

The sample size and statistical assumptions are governed by the Minimal Risk Umbrella protocol. Reviewers should refer to the umbrella protocol for the overarching sample size justification and statistical framework.

Interpretation of Results

Results will be interpreted as exploratory and hypothesis-generating. The study is intended to help characterize how healthy adult endurance athletes respond to different fueling strategies during real-world training conditions. Findings will not be used to diagnose, treat, or manage medical conditions, and CGM data will be interpreted as wellness and performance-related information rather than clinical diagnostic data.

Consistency With Umbrella Protocol

This statistical plan is consistent with the Minimal Risk Umbrella protocol. The present protocol applies the umbrella’s general repeated-measures, minimal-risk, exploratory analytic framework to a specific comparison of endurance fueling strategies and associated glucose, performance, and tolerability outcomes. Reviewers evaluating the statistical methods should assess them in the context of the umbrella protocol’s approved statistical plan.

This prospective, open-label, interventional, within-participant repeated-measures study is designed to evaluate gut tolerability, perceived energy, performance-related run metrics, and continuous glucose monitoring responses during endurance runs completed under three fueling conditions: SAP maple syrup with Himalayan salt, processed energy gels, and no gels. Participants choose the order of conditions during two 14-day CGM phases, which may be consecutive or separated by a break of up to 14 days. The principal limitation is the absence of randomization and blinding, which increases susceptibility to expectation effects, selection bias, reporting bias, and confounding from differences in training status, route, weather, run intensity, prior nutrition, hydration, sleep, and familiarity with specific products. Participants may enter the study with strong beliefs about “real food” fuels or conventional gels, and these beliefs may influence subjective outcomes such as gut comfort, perceived effort, and energy. To address this limitation, the study includes an expectations questionnaire to quantify participant assumptions and preferences before outcome assessment, allowing expectation-related bias to be described and considered during interpretation. In addition, the use of repeated within-participant observations across SAP, gel, and no-gel sessions strengthens the design by enabling each athlete to serve as their own comparator across real-world training conditions. Alternative-gel carbohydrate amounts are not matched to SAP; differences in carbohydrate dose and formulation may contribute to observed differences and limit attribution to the fuel product itself.

The study design is justified because the research question is pragmatic, low risk, and highly relevant to endurance athletes seeking individualized fueling strategies. Existing sports-medicine guidance supports carbohydrate intake during longer endurance activity, often using glucose/fructose combinations with fluids and electrolytes, but SAP maple syrup remains less studied than processed gels despite biological plausibility, public interest in “real food” fueling, and common reports of gastrointestinal intolerance with conventional gels. Collecting real-world data through Strava-linked training metrics, participant-reported gut comfort and energy, and glucose monitoring provides a feasible and participant-centered way to assess whether SAP produces a tolerability and glucose-response signal comparable to gels or preferable to no gels. Although the sample is self-selected and may include athletes already interested in SAP or real-food fueling, the statistical approach, including adequate sample planning where feasible and potential stratification by participant characteristics such as training level, sex, age group, fueling experience, and baseline expectations, is intended to improve interpretability and identify subgroups in whom effects may differ.

Most importantly, this study is intended as a signal detection study rather than a definitive efficacy trial. A positive signal would justify more robust follow-up studies, such as randomized crossover trials, blinded or partially blinded product comparisons where feasible, controlled laboratory exercise testing, or larger pragmatic trials with prespecified stratification and tighter control of training and nutritional variables. Conducting this work under the Minimal Risk Citizen Science Umbrella Protocol is also central to its purpose: Efforia and the Minimal Risk Umbrella Protocol aim to democratize clinical research by enabling practical, participant-centered studies and supporting research questions and researchers that might otherwise be overlooked by traditional funding and academic infrastructure. This protocol therefore balances methodological caution with accessibility, using minimal-risk procedures to generate preliminary evidence while transparently acknowledging limitations. Individuals seeking additional information about the oversight framework, study model, and safeguards should refer to the Minimal Risk Umbrella Protocol.