Blood Sugar; HighNCT06333496
Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans
A study testing GLP-1 Booster (GB) in people with Blood Sugar; High and Overweight and Obesity, run by Alpine Biotech LLC at 1 site in United States.
Trial summary
BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar; High, Overweight and Obesity, Fat Burn
- What is being tested?
- GLP-1 Booster (GB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to 8 May 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers must be over the age of 18.
- Volunteers cannot be smokers.
- Volunteers cannot be currently taking a dietary supplement or prescription for weight loss.
- Exercising volunteers must maintain their regimen consistently throughout the course of the 12-week study.
- Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 12-week study.
- Volunteers need to be overweight but not obese, as defined by having a BMI between 25.0 and 29.9
Who cannot join
- Female volunteers who are pregnant or planning to become pregnant within the next three months.
- Volunteers who are taking any stimulant medications (e.g. Adderall, Adzenys, Dexedrine, Ritalin, Methylphenidate, etc).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Glucagon Like Peptide 1 (GLP1) Booster on Blood Glucose, HbA1c, Insulin, and GLP1 Levels, Body Weight and Body Fat in Overweight Adult Men and Women
BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.
PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.
SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints.
- Being tested
- GLP-1 Booster (GB)
- Medical subject headings
- Hyperglycemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 Booster (GB)Dietary supplement
GLP-1 Booster (GB) is a composition designed to increase the endogenous production of GLP-1, improve the activity of GLP-1, enhance the body's response to GLP-1, and thus eventually help people reduce glucose, suppress food intake and lose body fat. GB contains Green tea (Camellia sinensis) leaf extract, Gardeniae (Gardenia jasminoides Ellis) fructus extract, Turmeric (Curcuma longa) root extract, Black pepper (Piper nigrum) extract,Fenugreek (Trigonella foenum-graecum) seed extract, Ginseng (Panax ginseng) root extract, and White kidney bean (Phaseolus vulgaris) extract. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 Booster | Experimental | GLP-1 Booster (GB) is a composition designed to increase the endogenous production of GLP-1, improve the activity of GLP-1, enhance the body's response to GLP-1, and thus eventually help people reduce glucose, suppress food intake and lose body fat. GB contains Green tea (Camellia sinensis) leaf extract, Gardeniae (Gardenia jasminoides Ellis) fructus extract, Turmeric (Curcuma longa) root extract, Black pepper (Piper nigrum) extract,Fenugreek (Trigonella foenum-graecum) seed extract, Ginseng (Panax ginseng) root extract, and White kidney bean (Phaseolus vulgaris) extract. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile. Receives: Dietary Supplement: GLP-1 Booster (GB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose level
Measured: 12 week
blood HbA1c level
Measured: 12 week
blood insulin level
Measured: 12 week
blood GLP1 level
Measured: 12 week
blood cholesterol level
Measured: 12 week
body weight
Measured: 12 week
body fat mass
Measured: 12 week
body lean mass
Measured: 12 week
body mass index
Measured: 12 week
body fat index
Measured: 12 week
waist hip ratio
Measured: 12 week
Secondary outcomes (4)
Satiety score
Measured: 12 week
Resting metabolic rate
Measured: 12 week
Blood pressure
both systolic and diastolic pressures
Measured: 12 week
Heart rate
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start2 Jan 2024
- Primary completion29 Mar 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Sugar; HighStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpine Biotech LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawry Han, PhD, Principal investigator, Alpine Biotech LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333496
- Sponsor's protocol ID
- AB20240102H
- Status last verified
- Jun 2024
- First submitted
- 11 Mar 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Glucagon Like Peptide 1 (GLP1) Booster on Blood Glucose, HbA1c, Insulin, and GLP1 Levels, Body Weight and Body Fat in Overweight Adult Men and Women
- ClinicalTrials.gov ID
- NCT06333496
- Acronym / sponsor ID
- AB20240102H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alpine Biotech LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 27 Mar 2024 (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.
BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.
PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.
SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 Booster | Experimental | Dietary Supplement: GLP-1 Booster (GB)GLP-1 Booster (GB) is a composition designed to increase the endogenous production of GLP-1, improve the activity of GLP-1, enhance the body's response to GLP-1, and thus eventually help people reduce glucose, suppress food intake and lose body fat. GB contains Green tea (Camellia sinensis) leaf extract, Gardeniae (Gardenia jasminoides Ellis) fructus extract, Turmeric (Curcuma longa) root extract, Black pepper (Piper nigrum) extract,Fenugreek (Trigonella foenum-graecum) seed extract, Ginseng (Panax ginseng) root extract, and White kidney bean (Phaseolus vulgaris) extract. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteers must be over the age of 18.
- Volunteers cannot be smokers.
- Volunteers cannot be currently taking a dietary supplement or prescription for weight loss.
- Exercising volunteers must maintain their regimen consistently throughout the course of the 12-week study.
- Caffeine drinking volunteers must maintain their caffeine intake consistently throughout the course of the 12-week study.
Key exclusion criteria (2 listed)
- Female volunteers who are pregnant or planning to become pregnant within the next three months.
- Volunteers who are taking any stimulant medications (e.g. Adderall, Adzenys, Dexedrine, Ritalin, Methylphenidate, etc).
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 |
|---|---|---|
| GLP-1 Booster (GB)GLP-1 Booster (GB) is a composition designed to increase the endogenous production of GLP-1, improve the activity of GLP-1, enhance the body's response to GLP-1, and thus eventually help people reduce glucose, suppress food intake and lose body fat. GB contains Green tea (Camellia sinensis) leaf extract, Gardeniae (Gardenia jasminoides Ellis) fructus extract, Turmeric (Curcuma longa) root extract, Black pepper (Piper nigrum) extract,Fenugreek (Trigonella foenum-graecum) seed extract, Ginseng (Panax ginseng) root extract, and White kidney bean (Phaseolus vulgaris) extract. Each of these ingredients has been commonly consumed by humans as food sources or supplements and thus has an undebatable safety profile. | Dietary supplement | GLP-1 Booster |
Primary outcome
blood glucose level
Time frame: 12 week
blood HbA1c level
Time frame: 12 week
blood insulin level
Time frame: 12 week
blood GLP1 level
Time frame: 12 week
blood cholesterol level
Time frame: 12 week
body weight
Time frame: 12 week
body fat mass
Time frame: 12 week
body lean mass
Time frame: 12 week
body mass index
Time frame: 12 week
body fat index
Time frame: 12 week
waist hip ratio
Time frame: 12 week
4 secondary outcomes
Satiety score
Time frame: 12 week
Resting metabolic rate
Time frame: 12 week
Blood pressure
Time frame: 12 week
Heart rate
Time frame: 12 week
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 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Lawry Han, PhD principal investigator
Alpine Biotech LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 Booster (GB) in people with Blood Sugar; High and Overweight and Obesity, run by Alpine Biotech LLC 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 6 inclusion and 2 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 5 Dec 2024. 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?
blood glucose level (time frame: 12 week). The study lists 11 primary outcomes in all. 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 5 Dec 2024.