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Carbohydrates and Related Biomarkers (CARB)

Primary Purpose

Healthy, Overweight

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low Glycemic Load Diet

High Glycemic Load Diet

About this trial

This is an interventional prevention trial for Healthy focused on measuring Glycemic response, Glycemic index, Obesity, Carbohydrates, Insulin, Blood glucose

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy males and female subjects
Between the ages of 18 to 45
BMI between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9 kg/m2 (overweight)
Willingness to refrain from alcohol during the study
Able to come to the FHCRC in Seattle every weekday night for dinner

Exclusion Criteria:

Younger than 18 years of age or older than 45 years of age.
Do not fit into one of the study weight groups (normal weight and overweight): BMI < 18.5 kg/m2 or > 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2
Have diseases that are treated by diet and/or medications including but not limited to diabetes, kidney disease, heart disease
Taking prescription medications every day (this includes women taking birth-control pills, shots, patch or IUD with hormones)
Diagnosed with or treated for cancer within the previous five years (except those with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible)
Currently pregnant or breastfeeding or planning a pregnancy in the next 3 months.
Using any tobacco products on a daily basis (cigarettes, pipes, cigars, chewing tobacco).
Using recreational drugs
Drinking the following amount of alcohol almost every day: 2 or more cans/bottles of beer OR 2 or more glasses of wine OR 3 or more ounces of hard liquor.
Inability (e.g., food allergy or intolerances) or unwillingness to consume the foods that are part of the feeding study diet.

Sites / Locations

Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

Normal weight

Overweight

Outcomes

Primary Outcome Measures

The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

Secondary Outcome Measures

Questionnaires will generate data on how these diets may influence mood or depression, sleep habits, and measures of appetite and satiety.

Full Information

NCT ID

NCT00622661

First Posted

February 14, 2008

Last Updated

January 4, 2012

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00622661

Brief Title

Carbohydrates and Related Biomarkers

Acronym

CARB

Official Title

A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

Detailed Description

This is a randomized, crossover feeding study conducted in normal weight and overweight individuals. Participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. The two feeding periods will be separated by a 28 day "washout" period when participants will eat their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each evening, breakfast, lunch and snacks will be brought home for the next day. On Friday evenings all the food will be taken home for the weekend. Samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. All urine will be collected for 24 hours at the end of each feeding period. A number of questionnaires will also be completed during each diet period. A small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. The stool sample collection is optional. One can decide not to provide a stool sample and still participate in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Overweight

Keywords

Glycemic response, Glycemic index, Obesity, Carbohydrates, Insulin, Blood glucose

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Normal weight

Arm Title

Arm Type

Other

Arm Description

Overweight

Intervention Type

Other

Intervention Name(s)

Low Glycemic Load Diet

Intervention Description

consume both high and low glycemic load diets for 28 days each

Intervention Type

Other

Intervention Name(s)

High Glycemic Load Diet

Intervention Description

consume both high and low glycemic load diets for 28 days each

Primary Outcome Measure Information:

Title

The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

Time Frame

two 4-week feeding periods (56 days total)

Secondary Outcome Measure Information:

Title

Questionnaires will generate data on how these diets may influence mood or depression, sleep habits, and measures of appetite and satiety.

Time Frame

two 4-week feeding periods (56 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males and female subjects Between the ages of 18 to 45 BMI between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9 kg/m2 (overweight) Willingness to refrain from alcohol during the study Able to come to the FHCRC in Seattle every weekday night for dinner Exclusion Criteria: Younger than 18 years of age or older than 45 years of age. Do not fit into one of the study weight groups (normal weight and overweight): BMI < 18.5 kg/m2 or > 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2 Have diseases that are treated by diet and/or medications including but not limited to diabetes, kidney disease, heart disease Taking prescription medications every day (this includes women taking birth-control pills, shots, patch or IUD with hormones) Diagnosed with or treated for cancer within the previous five years (except those with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible) Currently pregnant or breastfeeding or planning a pregnancy in the next 3 months. Using any tobacco products on a daily basis (cigarettes, pipes, cigars, chewing tobacco). Using recreational drugs Drinking the following amount of alcohol almost every day: 2 or more cans/bottles of beer OR 2 or more glasses of wine OR 3 or more ounces of hard liquor. Inability (e.g., food allergy or intolerances) or unwillingness to consume the foods that are part of the feeding study diet.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marian Neuhouser, RD, PhD

Organizational Affiliation

Fred Hutchinson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33219392

Citation

Dibay Moghadam S, Navarro SL, Shojaie A, Randolph TW, Bettcher LF, Le CB, Hullar MA, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Plasma lipidomic profiles after a low and high glycemic load dietary pattern in a randomized controlled crossover feeding study. Metabolomics. 2020 Nov 20;16(12):121. doi: 10.1007/s11306-020-01746-3.

Results Reference

derived

PubMed Identifier

31432072

Citation

Navarro SL, Tarkhan A, Shojaie A, Randolph TW, Gu H, Djukovic D, Osterbauer KJ, Hullar MA, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Plasma metabolomics profiles suggest beneficial effects of a low-glycemic load dietary pattern on inflammation and energy metabolism. Am J Clin Nutr. 2019 Oct 1;110(4):984-992. doi: 10.1093/ajcn/nqz169.

Results Reference

derived

PubMed Identifier

29458053

Citation

Ginos BNR, Navarro SL, Schwarz Y, Gu H, Wang D, Randolph TW, Shojaie A, Hullar MAJ, Lampe PD, Kratz M, Neuhouser ML, Raftery D, Lampe JW. Circulating bile acids in healthy adults respond differently to a dietary pattern characterized by whole grains, legumes and fruits and vegetables compared to a diet high in refined grains and added sugars: A randomized, controlled, crossover feeding study. Metabolism. 2018 Jun;83:197-204. doi: 10.1016/j.metabol.2018.02.006. Epub 2018 Feb 17.

Results Reference

derived

PubMed Identifier

27507131

Citation

Breymeyer KL, Lampe JW, McGregor BA, Neuhouser ML. Subjective mood and energy levels of healthy weight and overweight/obese healthy adults on high-and low-glycemic load experimental diets. Appetite. 2016 Dec 1;107:253-259. doi: 10.1016/j.appet.2016.08.008. Epub 2016 Aug 6.

Results Reference

derived

PubMed Identifier

26165375

Citation

Barton S, Navarro SL, Buas MF, Schwarz Y, Gu H, Djukovic D, Raftery D, Kratz M, Neuhouser ML, Lampe JW. Targeted plasma metabolome response to variations in dietary glycemic load in a randomized, controlled, crossover feeding trial in healthy adults. Food Funct. 2015 Sep;6(9):2949-56. doi: 10.1039/c5fo00287g.

Results Reference

derived

PubMed Identifier

22892437

Citation

Runchey SS, Pollak MN, Valsta LM, Coronado GD, Schwarz Y, Breymeyer KL, Wang C, Wang CY, Lampe JW, Neuhouser ML. Glycemic load effect on fasting and post-prandial serum glucose, insulin, IGF-1 and IGFBP-3 in a randomized, controlled feeding study. Eur J Clin Nutr. 2012 Oct;66(10):1146-52. doi: 10.1038/ejcn.2012.107. Epub 2012 Aug 15.

Results Reference

derived

PubMed Identifier

22564018

Citation

Chang KT, Lampe JW, Schwarz Y, Breymeyer KL, Noar KA, Song X, Neuhouser ML. Low glycemic load experimental diet more satiating than high glycemic load diet. Nutr Cancer. 2012;64(5):666-73. doi: 10.1080/01635581.2012.676143. Epub 2012 May 7.

Results Reference

derived

PubMed Identifier

22190020

Citation

Neuhouser ML, Schwarz Y, Wang C, Breymeyer K, Coronado G, Wang CY, Noar K, Song X, Lampe JW. A low-glycemic load diet reduces serum C-reactive protein and modestly increases adiponectin in overweight and obese adults. J Nutr. 2012 Feb;142(2):369-74. doi: 10.3945/jn.111.149807. Epub 2011 Dec 21.

Results Reference

derived

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Carbohydrates and Related Biomarkers

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