Clinical trial NCT01731366: The Effect of Whole Grain on Gut Microbiome and Metabolic Health
Official title: Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Disease
Injury of Gastrointestinal Tract
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
First posted: 2012-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Objective: To identify how specific changes of the whole grain content in the diet affect the host-gut microbiome interactions with implications for metabolic health .

Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included.

Intervention: low vs. high whole grain intake.

Detailed description: The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a diet rich in whole grain in the active treatment period and a refined grain diet during the control period.

Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, appetite hormones, transit time, and GM composition. Furthermore, selected control measures are included; 4-day food records and a study intervention diary.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI): 25 - 35 kg/m2
* No medical prescribed diet
* Weight stable
* No blood donation during the study
* Intense sporting activities less than 10h/ week
* Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male)
* Signed written consent

Exclusion Criteria:

* Pharmacological treatment; hypertension, diabetes and blood lipid regulation
* Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
* Participation in another biomedical trial 1 month prior to study start
* Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
* Reported chronic gastrointestinal disorders
* Antibiotic treatment for 3 month prior to study start
* Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start
* Blood hemoglobin \< 7.0 mmol/l
* Blood donation within 1 month prior to study start

Primary outcomes:
measure: HOMA-IR
timeFrame: At the end of the intervention periods
measure: Metagenomic profile
timeFrame: At the end of the intervention periods
Secondary outcomes:
measure: Mean intestinal transit time
timeFrame: At the end of the intervention periods
measure: Gastrointestinal permeability, Lactulose/ mannitol ratio
timeFrame: At the end of the intervention periods
measure: Colonic fermentation
timeFrame: At the end of the intervention periods
measure: Saliva microbial flora
timeFrame: At the end of the intervention periods
measure: Blood pressure
timeFrame: At the end of the intervention periods
measure: Appetite hormones
timeFrame: At the end of the intervention periods
measure: Blood lipid profile
timeFrame: At the end of the interventions periods
measure: Body composition
timeFrame: At the end of the intervention periods
measure: Subjective appetite sensation
timeFrame: At the end of the intervention periods
measure: Energy intake
timeFrame: At the end of the intervention periods
measure: Ex vivo cytokine production
timeFrame: At the end of the intervention periods
measure: Gene expression
timeFrame: At the end of the intervention periods
measure: Immune cell profiling
timeFrame: At the end of the intervention periods
measure: Immune markers
timeFrame: At the end of the intervention periods
measure: Blood immune cell content
timeFrame: At the end of the intervention periods
measure: Markers og glucose hemostasis
timeFrame: At the end of the intervention periods
measure: Markers of one-carbon metabolism
timeFrame: At the end of the intervention periods
measure: Plasma adipokines
timeFrame: December 2015
Other outcomes:
measure: 4-days precoded food diary
timeFrame: December 2014
measure: n-3 fatty acid status
timeFrame: At the end of the intervention periods
measure: Alkyresorcinol
timeFrame: At the end of the intervention periods
Locations:
city: Fredriksberg
country: Denmark
facility: Department of Human Nutrition, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Lotte Lauritzen, Associate professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lind MV, Lauritzen L, Vestergaard H, Hansen T, Pedersen O, Kristensen M, Ross AB. One-carbon metabolism markers are associated with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):402-410. doi: 10.1016/j.numecd.2018.01.005. Epub 2018 Jan 31.
citation: Roager HM, Vogt JK, Kristensen M, Hansen LBS, Ibrugger S, Maerkedahl RB, Bahl MI, Lind MV, Nielsen RL, Frokiaer H, Gobel RJ, Landberg R, Ross AB, Brix S, Holck J, Meyer AS, Sparholt MH, Christensen AF, Carvalho V, Hartmann B, Holst JJ, Rumessen JJ, Linneberg A, Sicheritz-Ponten T, Dalgaard MD, Blennow A, Frandsen HL, Villas-Boas S, Kristiansen K, Vestergaard H, Hansen T, Ekstrom CT, Ritz C, Nielsen HB, Pedersen OB, Gupta R, Lauritzen L, Licht TR. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial. Gut. 2019 Jan;68(1):83-93. doi: 10.1136/gutjnl-2017-314786. Epub 2017 Nov 1.