Weight LossNCT07280403
Effect of a Low-carbohydrate Diet on Weight Loss in People Using the Injectable GLP-1 Agonist Semaglutide for Weight Loss
A study testing Low Carbohydrate and Low Fat in people with Weight Loss, run by INQUIS Clinical Research at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine the effect of a low carbohydrate higher protein diet, modelled after the Atkins program on weight loss, glycemic control, risk markers of cardiovascular disease and body composition in patients taking semaglutide. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Low Carbohydrate and Low Fat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2024to 30 Nov 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, inclusive
- Overweight or obese individuals with a BMI ≥26 kg/m²
- Non-pregnant, non-lactating individuals who are not planning on becoming pregnant during the trial and are using an effective method of contraception, as outlined: (a) Complete abstinence from intercourse two weeks prior to administration of the study product, and throughout the clinical trial. Participants utilizing this method must agree to use 2 alternate methods of contraception (see d) if they should become sexually active and will be queried on whether they have been abstinent at each study visit. b) Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant; c) Sexual partner(s) is/are exclusively female; d) Use of two acceptable methods of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), tubal ligation, contraceptive pill, intrauterine device (IUD) or contraceptive implant. The Participant must be using these methods for at least 1 week prior to the screening visit and throughout their participation in the trial.
- Started semaglutide injections for weight loss 14 to 35 days prior to screening, inclusive, are tolerating it and are willing to continue taking it
- HbA1c ≤7.5%
- Not taking any hypoglycemic agent, apart from a semaglutide
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- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg
- Serum creatinine <180 mmol/L (<2.1 mg/dL)
- Serum triglycerides <9 mmol/L (<800 mg/dL)
- ALT or AST <3 times the upper limit of normal
- Untreated LDL-cholesterol <5.00 mmol/l (<193 mg/dL)
- No major illness, trauma or surgery requiring hospitalization within 3mo of the screening visit
- Ability to understand the study procedures and willing to provide informed consent to participate in the study
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
- Subjects are willing to sign the informed consent prior to any procedures conducted
Who cannot join
- Failure to meet any one of the inclusion criteria
- High alcohol consumption (>14 standard drinks per week or >4 standard drinks per day for males; and > 7 standard drinks per week or >3 standard drinks per day for females), with 1 standard drink defined as containing approximately 14g of pure alcohol. Examples of 1 standard drink include: 12 oz of regular beer (approx. 5% alcohol), 5 oz of wine (approx. 12% alcohol) or 1.5 oz of distilled spirits (approx. 40% alcohol)
- Individuals with a history of bariatric surgery, gastrointestinal disease, any other medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- Known intolerance, sensitivity, or allergy to any ingredients in the study test products
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Low-carbohydrate Diet on Weight Loss in People Using the Injectable GLP-1 Agonist Semaglutide for Weight Loss: a Pilot Trial
The goal of this clinical trial is to determine the effect of a low carbohydrate higher protein diet, modelled after the Atkins program on weight loss, glycemic control, risk markers of cardiovascular disease and body composition in patients taking semaglutide.
Participants will:
- Be randomized to follow either a low carb, higher protein diet or a low fat diet for 3 months.
- Visit the clinic at week 2, 4, 8 and 12 to meet with a dietician, fill out a symptoms questionnaire and for bloodwork
- Complete 3-day food records 4 times over the 12 weeks.
- Conditions
- Weight Loss
- Being tested
- Low Carbohydrate, Low Fat
- Keywords
- GLP-1 agonist, Semaglutide, Ozempic, Wegovy
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low CarbohydrateBehavioural
Low carbohydrate diet
Low FatBehavioural
Low fat diet
| Study group | Role | What they receive |
|---|---|---|
| Low Carbohydrate | Experimental | Subjects randomized to the low-carbohydrate arm will be instructed on a reduced calorie diet (<1400 kcal/day) consisting of an average macronutrient distribution of 20% carbohydrate, 30% protein and 50% fat with a maximum intake of 40g/day of available (net) carbohydrates (approximately 65-75g total carbohydrates). To complement the provided low carbohydrate shakes and snacks, dietary counselling will focus on choosing sources of protein and non-starchy vegetables Receives: Behavioral: Low Carbohydrate |
| Low Fat | Active comparator | Subjects randomized to the low-fat arm will be instructed on a reduced calorie diet (<1400 kcal/day) consisting of an average macronutrient distribution of 50% carbohydrate, 20% protein and 30% fat, with a maximum intake of 50g/day of fat. To complement the provided low fat shakes and snacks, dietary counselling will focus on choosing lean sources of protein and carbohydrates, while limiting high fat foods such as oils, nuts, full fat dairy, and fatty meats. Receives: Behavioral: Low Fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Percentage change from baseline of body weight
Measured: 12 weeks
Secondary outcomes (7)
BMI
Change from baseline of BMI
Measured: 12 weeks
Fat Mass
Change from baseline of Fat Mass
Measured: 12 weeks
Fasting plasma glucose
Change from baseline of fasting plasma glucose
Measured: 12 weeks
Fat-free mass
Change from baseline of Fat-Free Mass
Measured: 12 weeks
Skeletal Muscle Mass
Change from baseline of Skeletal Muscle Mass
Measured: 12 weeks
Fasting serum insulin
Change from baseline of fasting serum insulin
Measured: 12 weeks
Insulin sensitivity index
Change from baseline of HOMA-IR
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start12 Sep 2024
- Primary completion14 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label parallel design
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- INQUIS Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simply Good Foods USA, Ltd.
- Responsible party
- Sponsor
- Investigators
- Janice Campbell, Study director, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280403
- Sponsor's protocol ID
- INQ-2411
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Permission has not been sought to do so. Not shared to protect personal health information and participant identity.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-carbohydrate Diet on Weight Loss in People Using the Injectable GLP-1 Agonist Semaglutide for Weight Loss: a Pilot Trial
- ClinicalTrials.gov ID
- NCT07280403
- Acronym / sponsor ID
- INQ-2411
- Conditions
- Weight Loss
- Keywords
- GLP-1 agonist, Semaglutide, Ozempic, Wegovy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- INQUIS Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Simply Good Foods USA, Ltd.
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Dec 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 goal of this clinical trial is to determine the effect of a low carbohydrate higher protein diet, modelled after the Atkins program on weight loss, glycemic control, risk markers of cardiovascular disease and body composition in patients taking semaglutide.
Participants will:
- Be randomized to follow either a low carb, higher protein diet or a low fat diet for 3 months.
- Visit the clinic at week 2, 4, 8 and 12 to meet with a dietician, fill out a symptoms questionnaire and for bloodwork
- Complete 3-day food records 4 times over the 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label parallel design
| Arm | Type | Receives |
|---|---|---|
| Low Carbohydrate | Experimental | Behavioral: Low CarbohydrateSubjects randomized to the low-carbohydrate arm will be instructed on a reduced calorie diet (<1400 kcal/day) consisting of an average macronutrient distribution of 20% carbohydrate, 30% protein and 50% fat with a maximum intake of 40g/day of available (net) carbohydrates (approximately 65-75g total carbohydrates). To complement the provided low carbohydrate shakes and snacks, dietary counselling will focus on choosing sources of protein and non-starchy vegetables |
| Low Fat | Active comparator | Behavioral: Low FatSubjects randomized to the low-fat arm will be instructed on a reduced calorie diet (<1400 kcal/day) consisting of an average macronutrient distribution of 50% carbohydrate, 20% protein and 30% fat, with a maximum intake of 50g/day of fat. To complement the provided low fat shakes and snacks, dietary counselling will focus on choosing lean sources of protein and carbohydrates, while limiting high fat foods such as oils, nuts, full fat dairy, and fatty meats. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 18-75 years, inclusive
- Overweight or obese individuals with a BMI ≥26 kg/m²
- Non-pregnant, non-lactating individuals who are not planning on becoming pregnant during the trial and are using an effective method of contraception, as outlined: (a) Complete abstinence from intercourse two weeks prior to administration of the study product, and throughout the clinical trial. Participants utilizing this method must agree to use 2 alternate methods of contraception (see d) if they should become sexually active and will be queried on whether they have been abstinent at each study visit. b) Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant; c) Sexual partner(s) is/are exclusively female; d) Use of two acceptable methods of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), tubal ligation, contraceptive pill, intrauterine device (IUD) or contraceptive implant. The Participant must be using these methods for at least 1 week prior to the screening visit and throughout their participation in the trial.
- Started semaglutide injections for weight loss 14 to 35 days prior to screening, inclusive, are tolerating it and are willing to continue taking it
- HbA1c ≤7.5%
Key exclusion criteria (6 listed)
- Failure to meet any one of the inclusion criteria
- High alcohol consumption (>14 standard drinks per week or >4 standard drinks per day for males; and > 7 standard drinks per week or >3 standard drinks per day for females), with 1 standard drink defined as containing approximately 14g of pure alcohol. Examples of 1 standard drink include: 12 oz of regular beer (approx. 5% alcohol), 5 oz of wine (approx. 12% alcohol) or 1.5 oz of distilled spirits (approx. 40% alcohol)
- Individuals with a history of bariatric surgery, gastrointestinal disease, any other medical conditions or use of supplements or medications that increase risk to the subject or others or may affect the results, as judged by the Principal Investigator
- Unwillingness or inability to comply with the experimental procedures and to follow INQUIS safety guidelines
- Known intolerance, sensitivity, or allergy to any ingredients in the study test products
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 |
|---|---|---|
| Low CarbohydrateLow carbohydrate diet | Behavioural | Low Carbohydrate |
| Low FatLow fat diet | Behavioural | Low Fat |
Primary outcome
Body weight
Time frame: 12 weeks
Percentage change from baseline of body weight
7 secondary outcomes
BMI
Time frame: 12 weeks
Fat Mass
Time frame: 12 weeks
Fasting plasma glucose
Time frame: 12 weeks
Fat-free mass
Time frame: 12 weeks
Skeletal Muscle Mass
Time frame: 12 weeks
Fasting serum insulin
Time frame: 12 weeks
Insulin sensitivity index
Time frame: 12 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 18 Feb 2026.
- Individual participant dataSharing planned: No. Permission has not been sought to do so. Not shared to protect personal health information and participant identity.
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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.
Janice Campbell study director
INQUIS Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Carbohydrate and Low Fat in people with Weight Loss, run by INQUIS Clinical Research at 1 site in Canada.
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 15 inclusion and 6 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 18 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 Canada. 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?
Body weight (time frame: 12 weeks). 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 18 Feb 2026.