BridgeMD
New treatment option for Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
Official title The Satiety Control Optimization by Nutritional Enhancement Study
ClinicalTrials.gov ID: NCT07420023
What this study is testing
- What it's testing
- High-glycaemic foods contribute to elevated risk of obesity, type 2 diabetes, and cardiometabolic disease. Replacing digestible carbohydrates with dietary fibres is known to reduce postprandial glycaemic excursions, enhance satiety, and support beneficial microbial fermentation.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Be willing and able to give written informed consent.
- Be between 18 and 45 years of age.
- Have a BMI of =25\<30kg/m2(overweight).
- Have a waist circumference of \>94cm for a male, \>80cm for a female (increased risk of metabolic syndrome).
- Have had a stable body weight (\<5% change over the past three months).
You likely can't join if
- Pregnant, lactating, or post-menopausal women, or women who are planning to become pregnant over the study period.
- Have had antibiotic treatment within three months before baseline.
- Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the...
- Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
- Have a habitual alcohol consumption of \>2 alcoholic beverages/day (\>28g ethanol daily).
- Follow a vegetarian or vegan diet.
See the full eligibility criteria
- Be willing and able to give written informed consent.
- Be between 18 and 45 years of age.
- Have a BMI of =25\<30kg/m2(overweight).
- Have a waist circumference of \>94cm for a male, \>80cm for a female (increased risk of metabolic syndrome).
- Have had a stable body weight (\<5% change over the past three months).
- Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100...
- Be willing to avoid consuming dietary supplements (at the discretion of the investigator), prebiotics, probiotics, or fibre-rich supplements within four weeks before the baseline visit, and until the end of the study.
- Be willing to avoid vigorous physical activities on the treatment days (defined as any physical activity that is planned to achieve a fitness goal).
- Be willing to consume the investigational food products and menu plan daily for the duration of the study.
- Pregnant, lactating, or post-menopausal women, or women who are planning to become pregnant over the study period.
- Have had antibiotic treatment within three months before baseline.
- Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include anti-inflammatory drugs, H2...
- Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
- Have a habitual alcohol consumption of \>2 alcoholic beverages/day (\>28g ethanol daily).
- Follow a vegetarian or vegan diet.
- Have a typical fibre intake of \>30g per day.
- Have experienced major dietary changes within three months before the study baseline.
- Plan major lifestyle changes (diet, physical activity, or travel) during the study period.
- Have a clinically diagnosed eating disorder.
- Have a food allergy or intolerance that would preclude study product intake (for example, eggs, gluten, nuts, milk, or any other food allergy or intolerance).
- Have an active gastrointestinal disorder or previous gastrointestinal surgery.
- Have a significant active and medically-diagnosed acute or chronic co-existing illness including: metabolic, psychiatric, cardiovascular, endocrinological, immunological condition, gastrointestinal disease or any other...
- Are severely immunocompromised (e.g., HIV positive, transplant patient, on anti-rejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last 12 months).
- Have a malignant disease or concomitant end-stage organ disease.
- Have symptomatic respiratory or cardiac illness.
- Experience alarm features such as sudden weight loss, rectal bleeding, a recent change in bowel habits, or significant abdominal pain within three months before baseline.
- Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study protocol.
- Are receiving treatment involving experimental drugs.
- If the participant has been in a recent experimental trial, these must have been completed not less than 30 days before this study.
- Individuals who regularly undertake rigorous exercise.
- Individuals who smoke or vape.
The study team makes the final eligibility decision.
Where it's taking place
- Cork, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cork, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.