30 Day
MiraBurst Sweet-to-Sour Shift
| STUDY TITLE | MiraBurst Sweet-to-Sour Shift |
|---|---|
| Submitted under umbrella |
|
| Date submitted |
— |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation |
— |
| Recruitment page preview | |
| Informed consent | |
| Study author |
Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Participants will use 1 MiraBurst Mini Square once daily before a usual sweet-craving moment. After the Mini Square fully dissolves, participants will replace the sweet food they would normally eat with 1 predefined serving of a sponsor-selected bitter or sour food item. The routine is designed to keep the intervention consistent by pairing the taste-modifying Mini Square with the same type of sweet-food substitution each day. |
| Participant engagement length |
30 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services |
MiraBurst Mini Squares: $58
Lingo Continuous Glucose Monitor (CGM) & App by Abbott: $49
|
| Outcome measures |
Carbohydrate Craving Questionairre Sense of Agency Scale |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
No |
| ClinicalTrials.gov |
Yes |
| Commitment to list findings on ClinicalTrials.gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Reason I Created This Protocol:
Sugar cravings are a nightly siren song: social feeds tout “hack your sweet tooth,” while research suggests taste exposure, sour/bitter swaps, and mindful substitution may influence preference and intake. Miracle berry makes tart foods taste sweet—biology with a wink. We need real-world data, not comment-section confetti, to see whether this routine shifts cravings and control.
My Objective For You:
My objective is to help you test, in your own life, whether one daily MiraBurst Mini Square before your usual craving moment—followed by a consistent sour/bitter swap—can reduce carbohydrate cravings and strengthen your sense of agency by Day 33, while CGM data lets you see what your choices do under the hood.
Aims & Objectives:
This study aims to evaluate changes from Baseline to Day 33 in carbohydrate cravings, perceived control over eating choices, and glucose patterns during a structured sweet-to-sour substitution routine using MiraBurst Mini Squares and the Lingo CGM & App. You’ll get personalized results showing how the routine lands in your real life, helping you decide whether this kind of craving intervention deserves your time, attention, and money.
Significance & Impact:
If this approach works for some participants, it may offer a simple, low-friction way to interrupt the “sweet now, regret later” loop and build more intentional craving responses. Expected outcomes include reduced carbohydrate craving scores, improved Sense of Agency Scale scores, and clearer insight into glucose responses; limitations include short study duration, self-reported behavior, adherence variability, and the fact that this protocol is for wellness optimization, not diagnosis or treatment.
The Intervention
Included Products & Services
Product Name: MiraBurst Mini Squares
Quantity included: 30
Price: $58.00
Product Description: MiraBurst Mini Squares is a trademarked nutritional product. The Mini Squares are made from 100% pure miracle berry powder. The miracle berry is a fruit that, when consumed before eating or drinking, temporarily "rewires" the taste buds to turn sour or tart fruits, foods, and drinks sweet.
Product Image:
Ingredients:
MiraBurst Mini Squares contain only 1 ingredient: freeze-dried powder prepared from the fruit of Miracle berry (Synsepalum dulcificum). The ripe fruits are harvested from the shrubs of Synsepalum dulcificum grown on the company’s organic farms located in the Eastern and Western Regions of Ghana, West Africa. The berries are cultivated
using organic fertilizers and pesticides under Good Agricultural Practices. Berries that are harvested on the farms are transported under cool, dry conditions to the manufacturing site where they are visually inspected, weighed, sorted and washed with clean running water. The final wash is conducted with water pretreated with UV light.
The seeds are removed using a de-pulping machine which deposits the pulp into clean stainless-steel
containers, that are covered immediately. The pulp is then poured on stainless steel trays and blast
frozen. The frozen pulp is then freeze-dried and packaged into aluminum foil mylar bags and sealed. The
freeze-dried miracle berry powder is then weighed and placed in a refrigerator at 4 degrees Celsius
The frozen powder is shipped from Ghana to the US where it is milled and pressed into tablets. There
are no additives or preservatives added during the production of the tablets.
The Mini Squares are composed of 100% freeze-dried, powdered berry pulp.
Product Safety:
Miraculin: in vitro digestibility / allergenicity
Miraculin was shown to be fully and rapidly digested by pepsin in an in vitro digestibility assay. A
proteomic analysis of the digestibility assay indicated that it is highly unlikely that any of the protein will
remain intact within the gastrointestinal tract following digestion and therefore it is unlikely to be
absorbed intact into the body. The potential allergenicity and toxigenicity of miraculin was assessed
using a computerized model (in silico bioinformatic analyses). The results were that miraculin does not
represent a risk of allergy or toxicity to humans and has a low potential for cross-reactivity with other
allergens. A sensory study that characterizing the taste receptor activity of miraculin indicated that the
taste-modifying effect of miraculin at the concentration intended for product development has a rapid
onset and disappearance with no desensitizing impact on the receptor. The study authors concluded
that the use of miraculin to impact the sensory qualities of orally administered products with a
bitter/sour taste profile is not associated with any safety concerns.
Acute & 28-day toxicology studies - methanolic extracts
An acute toxicity study of a methanol extract of S. dulcificum pulp was conducted in rats. Cleaned, airdried fruit pulp was soaked in methanol at room temperature before filtration and the solvent evaporated to dryness. A total of 22 albino rats were used in a two-phase study. In phase I, three groups of 6 rats were orally administered with the extract (10 mg/kg, 100 mg/kg, and 1,000 mg/kg respectively for each group) by means of polythene cannula. The rats were monitored for 24 h for mortality and general behavior. In phase II, after 24 h, 3 individual rats were given three different concentrations (1600 mg/kg, 2900 mg/kg and 5000 respectively) orally, by means of polythene cannula. The fourth rats
received distilled water which served as control. The rats were monitored for 24 h for lethality and
general behavior. No mortality was observed, even at the highest dose of 5,000 mg/kg of the extract.
The report also detailed biochemical and histopathological examinations. In this part of the study, 24
albino rats, divided into 4 groups of 6 animals each, were orally administered saline, 100 mg, 200 mg
and 500 mg extract/kg body weight. Biochemical parameters including liver function enzymes, kidney
function parameters, serum electrolyte levels, serum total protein, serum total albumin, blood glucose
levels, serum lipid profile and lipid peroxidation were observed after 14 and 28 days. The livers and
kidneys of the animals were removed for histopathological studies. No negative effects on the health of
the rats were observed at any dose, the highest being 500 mg extract per kg body weight for 28 days.
A subacute toxicity study in rats was conducted using a methanolic extract of the fresh fruits of S.
dulcificum.19 The fruit was weighed, deseeded and homogenized (613 g) in 80% methanol left for 48 h
before filtrate collection. The filtrate was concentrated, and then lyophilized, resulting in a yield of 8.2%
extract (w/w). Male Wistar albino rats weighing 200-220 g were randomly divided into five groups with
five animals in each group. Group I served as the control and received distilled water. Group II-V
received oral administration of 25 mg, 50 mg, 100 mg and 200 mg/kg extract/body weight respectively,
once daily for 14 consecutive days. Blood samples were analyzed for the presence of liver enzymes and
bilirubrin. The livers of the animals were homogenized and measured for levels of total protein content,
malondialdehyde and glutathione as well as the activities of catalase, glutathione-S-transferase and
glutathione peroxidase. No signs of liver toxicity were observed. Lower doses of 50-100 mg/kg were
associated with decreases in serum total bilirubin and hepatic malondialdehyde levels and an elevation
of glutathione-S-transferase activity. The author of the study opined that the results of the study
indicated that the extract at these doses might boost antioxidant defense and have hepatoprotective
properties. The top dose of 200 mg/kg extract was associated with an increase in hepatic
malondialdehyde and a decrease in glutathione levels and might indicate a decrease in antioxidant
defenses.
Product Name: Lingo Continuous Glucose Monitor (CGM) & App by Abbott
Quantity included: 1
Price: $49.00
Product Description: The Abbott Lingo CGM is an over-the-counter biosensor worn on the upper arm for up to 14 days, offering real-time glucose tracking via a dedicated iOS app. Designed for adults not on insulin, it provides personalized insights, habit-building coaching, and the **Lingo Count** metric to quantify glucose spikes. The app includes food/exercise logging, Apple Health integration, and challenges to improve metabolic health.
Product Image:
Ingredients: FDA 510k Summary: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233655.pdf
Product Safety:
Minor irritation at usage site.
Results from the device may exacerbate eating disorders in individuals prone to them.