Weight Loss
Conditions
Keywords
GLP-1 agonist, Semaglutide, Ozempic, Wegovy
Brief 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. 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.
Interventions
BEHAVIORALLow Carbohydrate
Low carbohydrate diet
BEHAVIORALLow Fat
Low fat diet
Sponsors
INQUIS Clinical Research
Simply Good Foods USA, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open-label parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 12 weeks | Percentage change from baseline of body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 12 weeks | Change from baseline of BMI |
| Fat Mass | 12 weeks | Change from baseline of Fat Mass |
| Fasting plasma glucose | 12 weeks | Change from baseline of fasting plasma glucose |
| Fat-free mass | 12 weeks | Change from baseline of Fat-Free Mass |
| Skeletal Muscle Mass | 12 weeks | Change from baseline of Skeletal Muscle Mass |
| Fasting serum insulin | 12 weeks | Change from baseline of fasting serum insulin |
| Insulin sensitivity index | 12 weeks | Change from baseline of HOMA-IR |
Countries
Canada
Contacts
STUDY_DIRECTORJanice Campbell
INQUIS Clinical Research
Outcome results
None listed