Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects Wi… (NCT02868177) | Clinical Trial Compass
CompletedPhase 2/3
Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes
France, Ireland, Serbia66 participantsStarted 2016-10
Plain-language summary
Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with abdominal obesity associated with impaired glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several glucose and lipid homeostasis related parameters since these data are still unknown for this specific dietary supplement formula. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.
Who can participate
Age range
35 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
I1. Fasting glycemia \> 6,1 mmol/L. (1,1 g/L). I2. 2 hours glycemia (OGTT) \> 7,8 mmol/L (1,4 g/L). I3. HbA1c \< 7% I4. Triglyceridemia \> 1,5 g/L. I5. Prediabetic or type-2 diabetic but not requiring immediate drug therapy according to the current recommendations (HAS, 2013).
I6. Waist circumference \> 94 cm for men or \> 80 cm for women. I7. With reported body weight variation \< 5% in the 3 months prior the randomization.
I8. Without significant change in food habits or in physical activity in the 3 months before randomization and agreeing to keep them unchanged throughout the study (no hyper-hypocaloric diet nor start-stop of sport activity planned in the next 7 months).
I9. For women: Non menopausal with the same reliable contraception since at least three months before the beginning of the study and agreeing to keep it during the entire duration of the study (hormonal contraception, intra uterine device or surgical intervention) or menopausal with or without hormone replacement therapy (oestrogenic replacement therapy begun from less than 3 months excluded).
I10. Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination.
I11. Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form.
I12. Affiliated with a social security scheme. I13. Agree to be re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.