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Multicomponent Nutrition Supplement
Nutrition for Brain and Body Health (BB-Health) Feasibility Trial (BB-Health Trial)
N/A
Waitlist Available
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
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
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognition
Secondary study objectives
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 study objectives
Weight loss
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.
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Who is running the clinical trial?
Tufts UniversityLead Sponsor
270 Previous Clinical Trials
594,843 Total Patients Enrolled
20 Trials studying Obesity
106,151 Patients Enrolled for Obesity
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,741 Total Patients Enrolled
74 Trials studying Obesity
292,486 Patients Enrolled for Obesity
University of FloridaOTHER
1,409 Previous Clinical Trials
767,175 Total Patients Enrolled
38 Trials studying Obesity
20,365 Patients Enrolled for Obesity
University of New HampshireOTHER
15 Previous Clinical Trials
105,445 Total Patients Enrolled
4 Trials studying Obesity
100,244 Patients Enrolled for Obesity
Susan B. Roberts, Ph.D.Principal InvestigatorJean Mayer USDA Human Nutrition Research Center on Aging
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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.