HealthyNCT05493553
Effects of an Intermittent Fasting and Dietary Supplement Regimen on Glycemic Variability
A study testing Dietary supplement regimen and Dietary supplement and intermittent fasting regimen in people with Healthy and Impaired Glucose Tolerance, run by Unicity International, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the short-term effect of a nutritional program consisting of a yerba mate supplement, fiber supplement, and intermittent fasting on glycemic variability in men and women with risk factors for impaired fasting glucose. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Impaired Glucose Tolerance
- What is being tested?
- Dietary supplement regimen and Dietary supplement and intermittent fasting regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 29 Sep 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 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥25.0 to <35.0 kg/m2
- At least 1 out of the 3 following criteria:
- Waist circumference >102 cm for men and >88 cm for women
- Family history of at least one parent or sibling with diagnosed impaired fasting glucose (IFG) or type 2 diabetes mellitus (T2DM)
- Sedentary lifestyle (based on self-report)
Who cannot join
- Fasting glucose ≥126 mg/dL or diagnosed with diabetes mellitus (type 1 or 2).
- Uncontrolled and/or clinically important pulmonary, hepatic, renal, cardiac, hematologic, immunologic, neurologic, psychiatric or biliary condition(s). Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
- History of or current diagnosis of conditions that may affect blood glucose levels.
- Any known food allergy as well as intolerance or sensitivity to study product ingredients and caffeine.
- Any extreme diets or history of eating disorders that in the opinion of the Clinical Investigator that may affect the study outcomes or the subject's ability to adhere to the study program.
Show all 22Show fewer
- Weight loss or gain > 4.5 kg within 90 days of Visit 1.
- Currently or planning to be on a weight loss or weight gain / muscle-building regimen program during the study.
- Major trauma or any other surgical event within 90 days of Visit 1.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Unstable use of hormonal contraceptives (change in medication regimen within 90 days of Visit 1).
- Unstable use of medications that affect blood glucose levels whereby stable is defined as no change in regimen within 90 days of Visit 1.
- Use of oral or injectable steroids (topical and inhaled are allowed) within 90 days of Visit 1
- Use of fiber supplements or intentionally increasing fiber intake within 30 days of Visit 1
- Use of yerba mate containing products (beverage, supplement) within 30 days of Visit 1
- Exposure to any non-registered drug product within 30 days prior to Visit 1
- Use of vitamin C-containing supplements (including multivitamins) within 24 hours of Visit 2 and during the study intervention period.
- Use of products containing salicylic acid (skin-care products are allowed if not used on the area surrounding the sensor) within 24 hours of Visit 2 and during the study intervention period.
- Use of topical marijuana or hemp products within 24 hours of Visit 2 and during the study intervention period.
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception during the study period.
- Recent history (within 12 months) of alcohol or substance abuse.
- Has a condition the Clinical Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: Effects of an Intermittent Fasting and Dietary Supplement Regimen on Glycemic Variability and Glycemic Control in Men and Women With Risk Factors for Impaired Fasting Glucose: A Sub-chronic Continuous Glucose Monitoring Pilot Study
The purpose of this study is to determine the short-term effect of a nutritional program consisting of a yerba mate supplement, fiber supplement, and intermittent fasting on glycemic variability in men and women with risk factors for impaired fasting glucose.
Read the detailed description
The purpose of this study is to determine the effect of a nutritional program which combines two different supplements (a yerba mate extract supplement and a fiber-based, vitamin-rich nutritional supplement) and intermittent fasting on glycemic variability and glycemic control in men and women with risk factors for impaired fasting glucose.
This study will be an exploratory pilot study with one screening visit, one baseline visit followed by a baseline phase, two intervention phases, and one follow-up visit. During the baseline phase, subjects will follow their regular dietary routines. During the 4-day Phase 1, subjects will take the yerba mate supplement once per day and the fiber supplement twice per day. During the 4-day Phase 2, subjects will continue the supplement regimen from Phase 1, while incorporating daily intermittent fasting for approximately 16 hours and eating for 8 hours. A continuous glucose monitor will be worn by each subject to continuously measure glucose throughout the study period.
- Conditions
- Healthy, Impaired Glucose Tolerance
- Being tested
- Dietary supplement regimen, Dietary supplement and intermittent fasting regimen
- Keywords
- Intermittent fasting, Yerba mate, Continuous glucose monitoring, Dietary supplements, Soluble fiber
- Medical subject headings
- Glucose Intolerance, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement regimenDietary supplement
Also called Balance, Unimate
The powdered, soluble fiber-based supplement contains soluble fibers, phytosterols, plant-derived polysaccharides, flavor, maltodextrin, orange juice powder, citric acid, vitamin and mineral blend, and sweetener. This is prepared in water and consumed twice per day, prior to a meal.
The yerba mate-based supplement (containing green yerba mate leaf extract, sweeteners, and flavor) is a powdered supplement prepared in water and consumed in the morning.
Dietary supplement and intermittent fasting regimenOther
Also called Feel Great
The dietary supplement regimen is the same as in Phase 1. The intermittent fasting protocol consists of a 16-hour fasting period and an 8-hour eating window.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | A baseline period (no supplements or intermittent fasting). |
| Phase 1 | Experimental | A four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals. Receives: Dietary Supplement: Dietary supplement regimen |
| Phase 2 | Experimental | A four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals, while also practicing daily intermittent fasting (16 hours fasting, 8 hours eating window). Receives: Other: Dietary supplement and intermittent fasting regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability
Within-subject change in glucose coefficient of variation (CV)
Measured: 3 days
Secondary outcomes (6)
Daytime and Overall Blood Glucose Levels
Daytime (6 am - 11:59 pm), Overall (24 hours)
Measured: 3 days
Daytime glycemic variability
Coefficient of variation (CV) of glucose values during daytime hours (6 am - 11:59 pm)
Measured: 3 days
Percent of time in range
70-140 mg/dL
Measured: 3 days
Percent of time below range
< 70 mg/dL
Measured: 3 days
Percent of time above range
> 140 mg/dL
Measured: 3 days
Gastrointestinal symptoms
Daily gastrointestinal tolerance questionnaire
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start8 Aug 2022
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Baseline (no supplements or intermittent fasting requirements) and two interventional phases (Phase 1: supplements only; Phase 2: supplements and intermittent fasting)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unicity International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Responsible party
- Sponsor
- Investigators
- Dawn Beckman, MD, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493553
- Sponsor's protocol ID
- BIO-2206
- Status last verified
- Oct 2022
- First submitted
- 5 Aug 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Intermittent Fasting and Dietary Supplement Regimen on Glycemic Variability and Glycemic Control in Men and Women With Risk Factors for Impaired Fasting Glucose: A Sub-chronic Continuous Glucose Monitoring Pilot Study
- ClinicalTrials.gov ID
- NCT05493553
- Acronym / sponsor ID
- BIO-2206
- Conditions
- Healthy, Impaired Glucose Tolerance
- Keywords
- Intermittent fasting, Yerba mate, Continuous glucose monitoring, Dietary supplements, Soluble fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Unicity International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 9 Aug 2022 (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 purpose of this study is to determine the short-term effect of a nutritional program consisting of a yerba mate supplement, fiber supplement, and intermittent fasting on glycemic variability in men and women with risk factors for impaired fasting glucose.
Detailed description
The purpose of this study is to determine the effect of a nutritional program which combines two different supplements (a yerba mate extract supplement and a fiber-based, vitamin-rich nutritional supplement) and intermittent fasting on glycemic variability and glycemic control in men and women with risk factors for impaired fasting glucose.
This study will be an exploratory pilot study with one screening visit, one baseline visit followed by a baseline phase, two intervention phases, and one follow-up visit. During the baseline phase, subjects will follow their regular dietary routines. During the 4-day Phase 1, subjects will take the yerba mate supplement once per day and the fiber supplement twice per day. During the 4-day Phase 2, subjects will continue the supplement regimen from Phase 1, while incorporating daily intermittent fasting for approximately 16 hours and eating for 8 hours. A continuous glucose monitor will be worn by each subject to continuously measure glucose throughout the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Baseline (no supplements or intermittent fasting requirements) and two interventional phases (Phase 1: supplements only; Phase 2: supplements and intermittent fasting)
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –A baseline period (no supplements or intermittent fasting). |
| Phase 1 | Experimental | Dietary Supplement: Dietary supplement regimenA four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals. |
| Phase 2 | Experimental | Other: Dietary supplement and intermittent fasting regimenA four-day period during which subjects will take a yerba mate supplement once per day in the morning and a fiber-based supplement twice per day prior to two meals, while also practicing daily intermittent fasting (16 hours fasting, 8 hours eating window). |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) ≥25.0 to <35.0 kg/m2
- Waist circumference >102 cm for men and >88 cm for women
- Family history of at least one parent or sibling with diagnosed impaired fasting glucose (IFG) or type 2 diabetes mellitus (T2DM)
- Sedentary lifestyle (based on self-report)
Key exclusion criteria (22 listed)
- Fasting glucose ≥126 mg/dL or diagnosed with diabetes mellitus (type 1 or 2).
- Uncontrolled and/or clinically important pulmonary, hepatic, renal, cardiac, hematologic, immunologic, neurologic, psychiatric or biliary condition(s). Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
- History of or current diagnosis of conditions that may affect blood glucose levels.
- Any known food allergy as well as intolerance or sensitivity to study product ingredients and caffeine.
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 |
|---|---|---|
| Dietary supplement regimenAlso: Balance, UnimateThe powdered, soluble fiber-based supplement contains soluble fibers, phytosterols, plant-derived polysaccharides, flavor, maltodextrin, orange juice powder, citric acid, vitamin and mineral blend, and sweetener. This is prepared in water and consumed twice per day, prior to a meal. The yerba mate-based supplement (containing green yerba mate leaf extract, sweeteners, and flavor) is a powdered supplement prepared in water and consumed in the morning. | Dietary supplement | Phase 1 |
| Dietary supplement and intermittent fasting regimenAlso: Feel GreatThe dietary supplement regimen is the same as in Phase 1. The intermittent fasting protocol consists of a 16-hour fasting period and an 8-hour eating window. | Other | Phase 2 |
Primary outcome
Glycemic variability
Time frame: 3 days
Within-subject change in glucose coefficient of variation (CV)
6 secondary outcomes
Daytime and Overall Blood Glucose Levels
Time frame: 3 days
Daytime glycemic variability
Time frame: 3 days
Percent of time in range
Time frame: 3 days
Percent of time below range
Time frame: 3 days
Percent of time above range
Time frame: 3 days
Gastrointestinal symptoms
Time frame: 2 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 1 Nov 2022.
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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.
Dawn Beckman, MD principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement regimen and Dietary supplement and intermittent fasting regimen in people with Healthy and Impaired Glucose Tolerance, run by Unicity International, Inc. at 1 site in United States.
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 5 inclusion and 22 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 1 Nov 2022. 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 United States. 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?
Glycemic variability (time frame: 3 days). 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 1 Nov 2022.