Elderberries and Obesity

NCT05723497 | Completed

• 1 other identifier: 18682
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Substrate oxidation

  Participants will be monitored by a metabolic cart at rest and while walking

  3.5 hours

• Glucose tolerance/insulin sensitivity

  Blood will be collected following a meal tolerance test

  3 hours

Study Arms (2)

Elderberry juice

EXPERIMENTAL

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

Other: Elderberry juice

Placebo beverage

PLACEBO COMPARATOR

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

Other: Placebo beverage

Interventions

Elderberry juice OTHER

Participants will consume elderberry juice 1-week.

Elderberry juice

Placebo beverage OTHER

Participants will consume placebo for 1-week.

Placebo beverage

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Nutrition and Exercise Physiology

Spokane, Washington, 99202, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: February 10, 2023
• Study Start: July 27, 2021
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)