Elderberries and Obesity

NCT ID: NCT05723497

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2022-09-02

Brief Summary

Previous studies in humans indicate that anthocyanin-rich berries can positively alter fat oxidation and insulin sensitivity. This study will determine if this is also true with elderberries, which are a more concentrated source of anthocyanins compared to other commonly consumed berries.

Conditions

Fuel Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Elderberry juice

Participants will consume elderberry juice twice/day for 1-week.

Group Type: EXPERIMENTAL

Elderberry juice

Intervention Type: OTHER

Participants will consume elderberry juice 1-week.

Placebo beverage

Participants will consume placebo beverage twice/day for 1-week.

Group Type: PLACEBO_COMPARATOR

Placebo beverage

Intervention Type: OTHER

Participants will consume placebo for 1-week.

Interventions

Elderberry juice

Participants will consume elderberry juice 1-week.

Intervention Type: OTHER

Placebo beverage

Participants will consume placebo for 1-week.

Intervention Type: OTHER

Eligibility Criteria

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

• Are not fully vaccinated against COVID-19 (at least 2-weeks out from final dose at time of staff meeting)
• Have a body mass index less than 25 kg/m2
• Are younger than 22 years of age, or older than 75 years of age
• Pregnant, lactating, or intending to become pregnant during the study period, or have given birth in the past year
• 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 or marijuana (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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington State University

OTHER

Sponsor Role: lead

Responsible Party

Patrick Solverson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nutrition and Exercise Physiology

Spokane, Washington, United States

Countries

United States

Other Identifiers

18682

Identifier Type: -

Identifier Source: org_study_id