Obesity, Unspecified
Conditions
Keywords
Obesity, Elderberry
Brief summary
The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.
Interventions
OTHERPlacebo Beverage
Participants will consume placebo beverage twice/day for 1-week.
OTHERElderberry Juice
Participants will consume elderberry juice 1-week.
Sponsors
Washington State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Double (ParticipantOutcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above
Exclusion criteria
* Pregnant or trying to become pregnant * Have a body mass index less than 25 kg/m2 * Are younger than 22 years of age, or older than 75 years of age * Known allergy or intolerance to elderberries * History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study * Adherence to restrictive (vegetarian or vegan) or extreme (fad \[ex. Ketogenic or Atkins\] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight * Habitual use of tobacco (including vaping) products in the last 6 months * Diagnosis or treatment of cancer in the past 3 years * Crohn's disease or diverticulitis * Suspected or known strictures, fistulas or physiological/mechanical GI obstruction * Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications * Type 2 diabetes requiring the use of medication * Fasting blood glucose > 125 mg/dL * Unable or unwilling to give informed consent or communicate with study staff * Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion) * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Substrate oxidation | 3.5 hours | Participants will be monitored by a metabolic cart at rest and while walking |
| Glucose tolerance/insulin sensitivity | 3 hours | Blood will be collected following a meal tolerance test |
| Gut Microbiome analysis | 5 minutes | Feces will be collected before and after the intervention |
Countries
United States
Outcome results
None listed