Influence of Flavonoids and Caffeine Supplementation on Resting Metabolism

NCT03752125 | Completed

• 1 other identifier: 18-0257
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect of ingesting caffeine and mixed flavonoids (4 capsules, split between breakfast and lunch) on energy expenditure and fat oxidation in a metabolic chamber with 20 women (non-obese, healthy, ages 20-47 years, pre-menopausal). We hypothesize that based on the existing literature, ingestion of a double dose of the caffeine-mixed flavonoid supplement compared to placebo will increase fat oxidation and increase 24 h energy expenditure by about 75 kilocalories.

Conditions

Diet Modification

Keywords

energy expenditure; caffeine; flavonoids; fat metabolism

Outcome Measures

Primary Outcomes (1)

• 24-hour energy expenditure (kilocalories/minute) from continuous respiratory exchange measurements (oxygen consumption, carbon dioxide production) in a metabolic chamber

  Energy expenditure (kilocalories) over 24 h in metabolic chamber with oxygen consumption and carbon dioxide production analyzers whereby energy expenditure is calculated from respiratory exchange data (oxygen consumption, carbon dioxide production) using standard equations

  24 hours

Secondary Outcomes (1)

• 24-hour fat oxidation (fat grams oxidized per minute) from continuous respiratory exchange measurements (oxygen consumption, carbon dioxide production) in a metabolic chamber

  24 hours

Study Arms (2)

Flavonoid, caffeine

EXPERIMENTAL

Flavonoid, caffeine capsules

Dietary Supplement: Flavonoid, caffeine

Placebo

PLACEBO COMPARATOR

Placebo capsules

Dietary Supplement: Placebo

Interventions

Flavonoid, caffeine DIETARY_SUPPLEMENT

2 flavonoid/caffeine capsules before breakfast, 2 capsules before lunch

Flavonoid, caffeine

Placebo DIETARY_SUPPLEMENT

2 placebo capsules before breakfast, 2 capsules before lunch

Placebo

Eligibility Criteria

• Age: 20 Years - 47 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women, ages 20 to 47 years
• Body mass index (BMI) between 18.5 and 33 kg/m2 (normal weight, overweight, mild obesity)
• Weight during the past 6 months has been somewhat stable (+/- 12 lbs)
• Low-to-moderate caffeine intake, defined as consuming on average: less than 3 servings per day of coffee (each about 8 fl. oz.) and/or energy drinks with caffeine; less than 3 soft drinks with caffeine and tea per day
• Premenopausal (self-report)
• Willingness to maintain habitual diet and physical activity patterns, and not lose weight throughout the study period
• Understands and agrees to all study procedures and signs the form providing informed consent to participate in the study
• Willingness to report and maintain normal schedule of hormonal therapy including oral contraceptive pills, hormonal IUD, Nuva Ring, or DepoProvera injections.
• Normal thyroid function as determined from a blood sample collected during pre-study baseline testing.
• Not pregnant as determined by a urine pregnancy test during pre-study baseline testing and prior to the second chamber session, and not planning to become pregnant during the study.
• Willingness to avoid vigorous exercise the day before each metabolic chamber session (e.g., intense running, cycling, swimming for 30 minutes and longer).

You may not qualify if:

• Taking medications for or suffering from a medical condition that may impact results related to metabolism (e.g. thyroid disorders, diabetes, mental disorders such as anxiety or depression, heart disease, arthritis, cancer).
• Heavy exerciser (defined as more than 300 minutes per week of moderate to vigorous exercise within the last two weeks)
• Thyroid hormone levels outside of the normal laboratory reference range
• Pregnant or lactating, or planning to become pregnant during the study
• Recent use of antibiotics (within last two weeks)
• History of smoking during the six months prior to study
• Recent signs or symptoms of infection, including cold or flu-like symptoms (within last 2 weeks)
• Conditions or diseases the investigator believes would interfere with ability to provide consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. These include the disease list above and other health problems that would make it difficult to comply with two 24-hour periods of confinement in the metabolic chamber such as panic disorder, cardiac arrhythmias, musculoskeletal disorders such as low back pain and osteoarthritis, and gastrointestinal disorders including reactions to supplements with caffeine and vitamin C, and food allergies.
• Inability or unwillingness to consume the foods that will be included in the provided meals when staying in the chamber
• History of drug or alcohol abuse (\>5 standard drinks per day)
• Taking herbal supplements or medications that may influence metabolism within 14 days prior to the study, including supplements containing bitter orange, guarana, fucoxanthin, and green coffee bean, and medications such as Meridia, Xenical, LipoRidAM, Advantra-Z, NuPhedrine, and Slim-10.
• Current consumption (or unwilling to stop intake 2 weeks prior) of flavonoid supplements, or a heavy consumer of green tea (\>3 cups per day)
• Near-daily use of tablets containing caffeine (e.g., NoDoz) (or unwillingness to stop 2 weeks prior to the study).
• High intake of caffeine from coffee, tea, energy drinks with caffeine, and soft drinks containing caffeine (or unwillingness to reduce intake for 2 weeks prior to the study and during the 4-week study).
• Prone to panic attacks when confined in a small room, especially when consuming caffeine.

Sponsors & Collaborators

• Appalachian State University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Interventions

Flavonoids; Caffeine

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Xanthines; Alkaloids; Purinones; Purines

Study Officials

• David C Nieman, DrPH

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Flavonoid and placebo capsules
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, crossover

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: November 23, 2018
• Study Start: April 22, 2018
• Primary Completion: December 15, 2018
• Study Completion: April 19, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)