NCT00622661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

3.1 years

First QC Date

February 14, 2008

Last Update Submit

January 4, 2012

Conditions

HealthyOverweight

Keywords

Glycemic responseGlycemic indexObesityCarbohydratesInsulinBlood glucose

Outcome Measures

Primary Outcomes (1)

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

    two 4-week feeding periods (56 days total)

Secondary Outcomes (1)

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

    two 4-week feeding periods (56 days)

Study Arms (2)

1

OTHER

Normal weight

Other: Low Glycemic Load DietOther: High Glycemic Load Diet

2

OTHER

Overweight

Other: Low Glycemic Load DietOther: High Glycemic Load Diet

Interventions

Low Glycemic Load DietOTHER

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

12
High Glycemic Load DietOTHER

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

12

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (9)

  • Hullar MA, Kahsai O, Curtis KR, Navarro SL, Zhang Y, Randolph TW, Levy L, Shojaie A, Kratz M, Neuhouser ML, Lampe PD, Raftery D, Lampe JW. Metabolic plasticity of the gut microbiome in response to diets differing in glycemic load in a randomized, crossover, controlled feeding study. Am J Clin Nutr. 2025 Sep;122(3):780-792. doi: 10.1016/j.ajcnut.2025.06.026. Epub 2025 Jul 5.

    PMID: 40619005DERIVED

  • 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.

    PMID: 33219392DERIVED

  • 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.

    PMID: 31432072DERIVED

  • 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.

    PMID: 29458053DERIVED

  • 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.

    PMID: 27507131DERIVED

  • 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.

    PMID: 26165375DERIVED

  • 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.

    PMID: 22892437DERIVED

  • 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.

    PMID: 22564018DERIVED

  • 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.

    PMID: 22190020DERIVED

MeSH Terms

Conditions

OverweightObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Marian Neuhouser, RD, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

June 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2010

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

US(1)