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Multicomponent Nutrition Supplement
+MCNS+WL for Obesity (BB-Health Trial)
N/A
Recruiting
Led By Susan B. Roberts, Ph.D.
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
Awards & highlights
BB-Health Trial Summary
This trial is testing a specific diet to see if it can improve cognition and brain blood flow in older adults at risk for cognitive decline.
Eligible Conditions
- Obesity
- Cognition
BB-Health Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognition
Secondary outcome measures
Macrovascular cerebral blood flow velocity in fasting state
Macrovascular cerebral blood flow velocity in fed state
Microvascular cerebral blood flow in fasting state
+1 moreOther outcome measures
Weight loss
BB-Health Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: -MCNS-WLActive Control1 Intervention
This group receives the placebo nutrition supplement and is in the control group for the behavioral weight loss intervention (no behavioral intervention during the trial, but participant is wait-listed to receive one after the trial finishes)
Group II: +MCNS+WLActive Control2 Interventions
This group receives the multicomponent nutrition supplement and the behavioral weight loss intervention.
Group III: +MCNS-WLActive Control1 Intervention
This group receives the multicomponent nutrition supplement and is in the control group for the behavioral weight loss intervention (no behavioral intervention during the trial, but participant is wait-listed to receive one after the trial finishes).
Group IV: -MCNS+WLPlacebo Group1 Intervention
This group receives the placebo nutrition supplement and the behavioral weight loss intervention.
Find a Location
Who is running the clinical trial?
Tufts UniversityLead Sponsor
264 Previous Clinical Trials
661,796 Total Patients Enrolled
19 Trials studying Obesity
105,931 Patients Enrolled for Obesity
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,307 Total Patients Enrolled
70 Trials studying Obesity
291,046 Patients Enrolled for Obesity
University of FloridaOTHER
1,340 Previous Clinical Trials
715,657 Total Patients Enrolled
36 Trials studying Obesity
26,915 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking any multivitamins or supplements that promote brain health or cognitive function.You follow a special diet that restricts certain types of food.You have a strong allergy to adhesive materials.You have smoked or vaped tobacco or marijuana, including eating marijuana products, within the past 6 months on a regular basis.You drink more than 2 cups of green or black tea every day, on average.You have access to a refrigerator or freezer at home with space for supplement storage.You have stomach or intestinal problems like ulcers, inflammatory bowel disease, or conditions that affect the absorption of nutrients.You have a long-term kidney problem or a history of kidney stones.You have been diagnosed with an eating disorder like anorexia, bulimia, or binge-eating in the past.You have a thyroid disease or another important hormonal disorder.You have a condition that affects how your body absorbs nutrients.You have had recent problems with diseases that cause inflammation in your body.You need to rate the taste of the study food as at least a 4 out of 5 during the screening.The amount of food you eat is within a normal and healthy range.You have had a past problem with your pancreas or gall bladder.You have used recreational or illegal drugs.You have reported being allergic to any of the ingredients in the foods provided for the study.You don't enjoy eating chocolate or cocoa, or you eat more than one serving per week of chocolate that is more than 60% cocoa.You have a history of brain-related diseases like stroke, seizures, or serious head injuries.You have had surgery to remove part of your stomach or bowel, or you have had a weight loss procedure like gastric bypass.
Research Study Groups:
This trial has the following groups:- Group 1: -MCNS-WL
- Group 2: +MCNS+WL
- Group 3: -MCNS+WL
- Group 4: +MCNS-WL
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research encompass participants over the age of 40?
"This research requires participants to be aged between 55 and 85 years old."
Answered by AI
What is the scope of the sample size in this medical research?
"Absolutely. Clinicaltrials.gov records show that the trial is actively seeking participants and was initially posted on September 13th 2022, with a recent update to its listing also occuring on this date. The study requires 48 patients for enrollment at one location."
Answered by AI
Are there any eligibility requirements for participants in this research?
"To qualify for this trial, patients should have a diagnosis of obesity and fall within the age range of 55 to 85. The team is looking to recruit approximately 48 individuals in total."
Answered by AI
Are recruitments still open for this research study?
"Per the clinicaltrials.gov listing, this trial is searching for participants and was initially posted on September 13th 2022 before being updated on that same day."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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