Phase 2 Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old (inclusive) at the time of screening
• People with a body mass index (BMI) of 25 or higher (a measure of body weight relative to height)
• Women who cannot become pregnant — either due to a surgical procedure such as removal of the uterus or ovaries, tubal ligation, or complete endometrial ablation, or because they have been through menopause for at least one year
• Women who could become pregnant, provided a pregnancy test at the start of the study is negative and an approved form of contraception has been used for at least three months before joining and throughout the study (acceptable methods include hormonal contraceptives, double-barrier methods, intrauterine devices, abstinence with agreement to use contraception if that changes, a partner's vasectomy of at least six months prior, or a non-heterosexual lifestyle)
• People with prediabetes or Type 2 diabetes with a blood sugar (HbA1c) level between 6.0% and below 9%, whose condition has been stable and whose diabetes medication has not changed in the past three months
• People whose body weight has been stable for the three months before the start of the study, based on self-report
• People who are motivated and able to follow the study's dietary guidelines, as assessed through a questionnaire at screening
• People who agree to keep their usual habits as consistent as possible throughout the study, including their medications, supplements (unless excluded), and sleep patterns
• People who are willing and able to complete questionnaires, food and activity records, follow dietary and exercise guidelines, and attend all required clinic visits
• People who have given voluntary written consent to take part in the study

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with a known allergy, sensitivity, or intolerance to any ingredients in the study product
• People with Type 1 diabetes
• People with Type 2 diabetes who are currently on insulin treatment
• People who have had gastric bypass surgery or any other weight-loss surgery
• People who are currently participating in, or have participated in, a weight loss or diet program within the past three months
• People with a current or past history of eating disorders, as assessed by the trial's qualified investigator (QI)
• People whose excess weight is caused by a hormonal or metabolic disorder (such as an overactive pituitary gland or a hypothalamic condition), as assessed by the QI
• People with a current or past history of significant digestive or gastrointestinal conditions, as assessed by the QI
• People with chronic inflammatory diseases, as assessed by the QI
• People with a history of gout who have had a flare-up within the past 12 months, as assessed by the QI
• People with an unstable kidney or liver condition, as assessed by the QI on a case-by-case basis (people with a history of kidney stones who have been symptom-free for at least six months may still be considered)
• People with a self-reported thyroid condition — though those on a stable thyroid medication dose for at least three months may be considered by the QI
• People who have had major surgery in the past three months or who have planned surgery during the study period (minor surgery cases may be considered individually by the QI)
• People with cancer, except those who have had a fully removed basal cell skin cancer with no chemotherapy or radiation and a clear follow-up, or those who have been in full remission for more than five years
• People currently using any prescription or over-the-counter medications or supplements that may affect blood sugar, body weight, or metabolism, as assessed by the QI
• People who have regularly used tobacco products within six months before the study starts or who plan to use them during the study, as assessed by the QI
• People who use cannabis products (inhaled or edible) more than once per month — occasional users may be considered if they agree to stop use before and throughout the study
• People who drink an average of more than two standard alcoholic drinks per day
• People with a history of alcohol or drug misuse within the past 12 months
• People with significantly abnormal laboratory test results at screening, as assessed by the QI
• People who have donated blood within 30 days before the study starts, plan to donate during the study, or plan to donate within 30 days after the last study visit
• People who have participated in another clinical research study within 30 days before the study starts, as assessed by the QI
• People who are unable to provide informed consent
• People with any other condition or lifestyle factor that, in the QI's opinion, could affect their ability to complete the study safely or put them at significant risk

Important: Always verify eligibility with the trial site directly before applying.