Absorption and Metabolic Profiles of a Sugar-based Beverage (SR)

January 25, 2021 updated by: Clinical Nutrition Research Center, Illinois Institute of Technology

Absorption Profile of a Sugar-based Beverage on Inflammatory Mechanism by Timing of Beverage Consumption Relative to Meal Intake.

Primary objective is to determine absorption profile of a sugar-based beverage on inflammatory mechanism by timing of beverage consumption relative to meal intake.

Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative and metabolic mechanism by timing of beverage consumption relative to meal intake.

The results will be served as an internal reference or negative control group to compare with polyphenol containing studies from other studies.

Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size of 12 will be recruited into this part of the study.

This study is a single-arm design utilizing a multiple sampling, and repeated measures paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute effect on inflammatory markers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A planned sample size of 12 will be recruited into the study. This study will require one initial screening visit, one pre-study visit, and 1 study visit. The study will take 1-2 weeks per subject to complete.

The initial screening visit will provide subject informed consent document and determine subject eligibility through height and weight measurements, vital signs, blood glucose test (finger prick), and completion of a survey related to general eating, health, and exercise habits.

If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at initial screening visit and collected at a pre-study visit to assess subjects' baseline dietary intake pattern. After reviewing baseline food records, subjects will be instructed to avoid any berry products throughout the study and follow a strictly limited polyphenolic diet for 3 days prior to the study visit, while maintaining their usual diet pattern and physical activity. Prior to 10-hr study visit, a dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit.

Subject will arrive at the study visit fasted for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and blood glucose measurements) , a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting. Thereafter, blood sample collection will occur every 1 hour for the next 10 hours. During the 10-hr study visit, subject will drink one of 3 identical placebo drinks at fasting (right after fasting blood draw), 2nd placebo drink with the breakfast meal (2 hrs after fasting blood draw) and the 3rd placebo drink at 2 hours after the breakfast meal (4 hrs after fasting blood draw).

Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety often resulting in increased intake.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Clinical Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older
  • Body Mass Index (BMI) range from 25 to 29.9 kg/m2; exception BMI 23 to 27.4 kg/m2 for Asian population
  • Nonsmoker
  • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements.
  • Able to provide informed consent
  • Able to comply and perform the procedures requested by the protocol Weight stable: not gained or lost weight +/- 5 kg in previous 3 months

Exclusion Criteria:

  • Men and women who smoke
  • Past smokers: abstinence for minimum 2 years
  • Men and women with known or suspected food intolerance, allergies or hypersensitivity
  • Men and women known to have/diagnosed with diabetes mellitus
  • Men and women who have fasting blood glucose concentrations > 125mg/dL
  • Men and women who have blood pressure >140 mmHg/90 mmHg
  • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
  • Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are lactating
  • Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
  • Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
  • Men and women who are vegans
  • Substance (alcohol or drug) abuse within the last 2 years.
  • Excessive coffee and tea consumers (> 4 cups/d)
  • Men and women who do excessive exercise regularly or athlete
  • Unstable weight: gained or lost weight +/- 5 kg in previous 3 months
  • Women who are taking hormonal contraceptive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 Placebo Beverages
Sugar beverage 2 hr before meal and with meal and 2 hr after meal
Dietary supplement: 3 Placebo Beverages
Sugar beverage 2 hr before meal, with meal and 2 hr after meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in inflammation markers over 10 hours after sugar beverage consumption at different time points.
Time Frame: 10 hr Postprandial paradigm
The timing influence of beverage consumption on inflammation markers in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
10 hr Postprandial paradigm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in oxidative stress markers over 10 hours after sugar beverage consumption at different time points.
Time Frame: 10 hr
The timing influence of beverage consumption on oxidative stress (oxidized LDL) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
10 hr

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in metabolic markers over 10 hours after sugar beverage consumption at different time points.
Time Frame: 10 hr
The timing influence of sugar beverage consumption on metabolic markers (triglyceride, total cholesterol,ApoB, and insulin) in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
10 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2014

Primary Completion (Actual)

January 13, 2015

Study Completion (Actual)

February 20, 2015

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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