HealthyNCT06966570
Acute Appetite Hormone Response of Proprietary Beverages
A study testing Study Product A: Mixed-macronutrient beverage and Study Product B: Single-macronutrient beverage in people with Healthy, run by Shaklee Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate post-meal appetite hormones and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Study Product A: Mixed-macronutrient beverage and Study Product B: Single-macronutrient beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 11 Jun 2025
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, ≥20 to ≤50 years of age.
- BMI ≥18.5 and <25.0 kg/m2.
- Self-reported regular consumer (≥5 days/week) of breakfast.
- Women who are either pre- or post-menopausal. Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior.
- Willing to use personal smart phone and capable of downloading the Cronometer app for diet records.
- Willing to adhere to all study procedures, including lifestyle considerations, and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Who cannot join
- Is currently following, or planning to be on, a weight loss regimen at any time prior to or during the study.
- Weight loss or gain >4.5 kg within 90 days.
- History of gastrointestinal surgery for weight reducing purposes.
- History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) or extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
- History of unconventional sleep patterns (e.g., night shift) or a diagnosed sleep disorder or chronic medical condition that may impact appetite (in the judgment of the Investigator).
- Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months.
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- Use of hemp/marijuana products within 60 days. Occasional use (e.g., once or twice a month) within 60 days is allowed.
- Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days.
- Unstable use (initiation or change in dose) within 30 days of hormonal contraceptives.
- Use of any dietary supplements, except for a conventional once daily multivitamin/mineral supplement.
- Recent history of (within 12 months) or strong potential for alcohol or substance abuse.
- Exposed to any non-registered drug product within 30 days prior.
- A score of <7 on the Vein Access Scale Assessment.
- History or presence, on the basis of the medical history or screening labs, of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).
- Known allergy to any ingredients contained in the study product or study foods.
- Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- History of any major trauma or major surgical event within 2 months.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use (initiation or change in dose within 30 days) of sex hormones for contraception.
- An employee or representative who has a financial interest in Shaklee Corporation.
- Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person 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: A Randomized, Single-Blind, Crossover Pilot Trial to Assess the Effects of Proprietary Beverages on Acute Appetite Hormone Response in Healthy Adults
The primary objective of this study is to evaluate post-meal appetite hormones and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults.
Read the detailed description
The primary objective of this study is to evaluate post-meal appetite hormones and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults compared to their baseline. It is hypothesized that beverages will result in an increase in appetite hormones and feelings of satiety compared to baseline.
- Conditions
- Healthy
- Being tested
- Study Product A: Mixed-macronutrient beverage, Study Product B: Single-macronutrient beverage
- Keywords
- appetite, beverages, healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Product A: Mixed-macronutrient beverageOther
Participants will consume a beverage that contains mixed macronutrients.
Study Product B: Single-macronutrient beverageOther
Participants will consume a beverage that contains a single macronutrient.
| Study group | Role | What they receive |
|---|---|---|
| Study Product A followed by Study Product B | Other | Not described Receives: Other: Study Product A: Mixed-macronutrient beverage; Other: Study Product B: Single-macronutrient beverage |
| Study Product B followed by Study Product A | Other | Not described Receives: Other: Study Product A: Mixed-macronutrient beverage; Other: Study Product B: Single-macronutrient beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) above baseline for appetite hormones
Measured: Up to 2 hours post-beverage consumption
Secondary outcomes (3)
Positive area under the curve (AUC) for appetite hormones
Measured: Up to 2 hours post-beverage consumption
Time to Cmax (Tmax) for appetite hormones
Measured: Up to 2 hours post-beverage consumption
Individual and composite appetite visual analog scale (VAS) ratings
Measured: Up to 2 hours post-beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2025
- Study start28 Apr 2025
- Primary completion23 May 2025
- Study completion11 Jun 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaklee Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Nlumn LLC
- Responsible party
- Sponsor
- Investigators
- Erin Barrett, PhD, Study director, Shaklee Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966570
- Sponsor's protocol ID
- BIO-2503
- Status last verified
- Oct 2025
- First submitted
- 29 Apr 2025
- Last updated
- 11 Feb 2026
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Crossover Pilot Trial to Assess the Effects of Proprietary Beverages on Acute Appetite Hormone Response in Healthy Adults
- ClinicalTrials.gov ID
- NCT06966570
- Acronym / sponsor ID
- BIO-2503
- Conditions
- Healthy
- Keywords
- appetite, beverages, healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shaklee CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Nlumn LLC
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 12 May 2025 (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 primary objective of this study is to evaluate post-meal appetite hormones and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults.
Detailed description
The primary objective of this study is to evaluate post-meal appetite hormones and appetite ratings, assessed using visual analog scale (VAS) questionnaires, in response to proprietary beverages in generally healthy adults compared to their baseline. It is hypothesized that beverages will result in an increase in appetite hormones and feelings of satiety compared to baseline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Product A followed by Study Product B | Other | Other: Study Product A: Mixed-macronutrient beverage, Other: Study Product B: Single-macronutrient beverage |
| Study Product B followed by Study Product A | Other | Other: Study Product A: Mixed-macronutrient beverage, Other: Study Product B: Single-macronutrient beverage |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females, ≥20 to ≤50 years of age.
- BMI ≥18.5 and <25.0 kg/m2.
- Self-reported regular consumer (≥5 days/week) of breakfast.
- Women who are either pre- or post-menopausal. Premenopausal women that are not using hormonal contraceptives must have a history of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior.
- Willing to use personal smart phone and capable of downloading the Cronometer app for diet records.
Key exclusion criteria (22 listed)
- Is currently following, or planning to be on, a weight loss regimen at any time prior to or during the study.
- Weight loss or gain >4.5 kg within 90 days.
- History of gastrointestinal surgery for weight reducing purposes.
- History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) or extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
- History of unconventional sleep patterns (e.g., night shift) or a diagnosed sleep disorder or chronic medical condition that may impact appetite (in the judgment of the Investigator).
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 |
|---|---|---|
| Study Product A: Mixed-macronutrient beverageParticipants will consume a beverage that contains mixed macronutrients. | Other | Study Product A followed by Study Product B, Study Product B followed by Study Product A |
| Study Product B: Single-macronutrient beverageParticipants will consume a beverage that contains a single macronutrient. | Other | Study Product A followed by Study Product B, Study Product B followed by Study Product A |
Primary outcome
Maximum concentration (Cmax) above baseline for appetite hormones
Time frame: Up to 2 hours post-beverage consumption
3 secondary outcomes
Positive area under the curve (AUC) for appetite hormones
Time frame: Up to 2 hours post-beverage consumption
Time to Cmax (Tmax) for appetite hormones
Time frame: Up to 2 hours post-beverage consumption
Individual and composite appetite visual analog scale (VAS) ratings
Time frame: Up to 2 hours post-beverage consumption
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 11 Feb 2026.
- 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.
Erin Barrett, PhD study director
Shaklee Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Product A: Mixed-macronutrient beverage and Study Product B: Single-macronutrient beverage in people with Healthy, run by Shaklee Corporation 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 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 11 Feb 2026. 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?
Maximum concentration (Cmax) above baseline for appetite hormones (time frame: Up to 2 hours post-beverage consumption). 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 11 Feb 2026.