NCT06626373Completed
Elderberry Consumption and Human Health
Elderberry Consumption and Human Health: a Preliminary Investigation Into Effects on Indirect Calorimetry, Insulin Sensitivity, and Microbiome
Source: ClinicalTrials.gov · Last updated 3 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 1 Oct 2024
- Start date
- 27 Feb 2023
- Primary completion date
- 10 May 2024
- Lead sponsor
- Washington State University
- Diseases
- Obesity
- NCT number
- NCT06626373
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 27 Feb 2023 to the primary completion date, 10 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
Other illness
- 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
- Diagnosis or treatment of cancer in the past 3 years
- Crohn's disease or diverticulitis
- Type 2 diabetes requiring the use of medication
- 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
Lab values
- Fasting blood glucose \> 125 mg/dL
Age
- Are younger than 22 years of age, or older than 75 years of age
Other
- Pregnant or trying to become pregnant
- Have a body mass index less than 25 kg/m2
- 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
- Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- 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)
Who the study is looking for
- Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above
Age in the registry: 22 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington State University Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.