Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6, Canada
Location status: Recruiting
NCT Number: NCT07257913
The primary objective is to investigate the impact of milk, fermented milk, and soy beverages, incorporated in a diet reflecting adherence to Canadian food guide recommendations on food choices on gut microbiota in middle-aged adults (45-65 years) with abdominal obesity and slightly deteriorated lipids and/or glucose profile. The study aims to discern whether the integration of soy beverages (control), milk, and fermented milk within the CFG diet contributes to distinct gut outcomes and alterations in gut health. We hypothesized that milk and fermented milk will further promote beneficial changes in gut health parameters including gut microbiota composition, trans-epithelial permeability, and inflammation, relative to soy beverages.
Interested in participating?
Request Info40 year–65 year
All sexes
Interventional
Not applicable
Québec, Quebec, G1V 0A6, Canada
Location status: Recruiting
Single-blinded crossover RCT to test the impact of integrating dairy (i.e., milk and fermented milk) into the Canadian Food Guide (CFG) diet on gut health, in fully controlled dietary settings. The trial will include mid-age women and men with abdominal obesity and slightly deteriorated metabolic profile (n=20). The trial will feature 3 controlled-feeding phases (14 days), allocated in a random order and separated by free-uncontrolled feeding washout periods (14-28 days). Each dietary intervention phase will be initiated by a Run-in full-feeding period (4 days), to standardize participants' dietary intakes, and immediately followed by one of the 3 dietary interventions (9 days) reflecting adherence to the CFG recommendation (9 days, CFG-Diet) incorporating either soy beverages (Control), milk, or non-effervescent fermented milk.
This approach was shown to be highly informative in deciphering the interaction between diet and the gut microbiota in previous work. It will be able to assess how integrating dairy (i.e., milk and fermented milk) into the Canadian Food Guide (CFG) diet promptly modulates gut health parameters (i.e. gut microbiota composition, inflammatory states, and gut permeability) in the context of obesity and metabolic complications, relative to a plant-based alternative. The fully controlled dietary setting of this study design will provide precise intakes of foods and bioactive nutrients, which will enable us to comprehensively assess the impact of dairies on gut health.
The trial will include 10 women and 10 men with abdominal obesity and slightly deteriorated metabolic profile.
Diet sequence allocation will be randomized with a sex-specific stratification. The study will be single-blinded, such as participants will not be informed of the precise nature of the diet sequence.
TRIAL INTERVENTION PHASES (3 X 14 DAYS)
During each intervention phases, all meals and foods will be provided to ensure optimal diet control. Each intervention phases will follow this sequence:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consumption of 1 cup milk 3 times per day during 9 days alongside CFG diet
Consumption of fermented milk 3 times per day during 9 days alongside CFG diet
Consumption of a soy beverage 3 times per day during 9 days alongside CFG diet
Time frame: This outcome will be measured on the last day (day 13) of each intervention phase.
Post-intervention lactulose/mannitol ratio by LCMS, 0-5 hours after ingestion of the non-metabolizable sugar
Time frame: Samples will be collected on days 6 and 13 of each intervention phase.
Fecal calprotectin levels by ELISA
Time frame: Gastrointestinal symptoms questionnaire is administered on days 0, 4 and 13.
Perception gastrointestinal symptoms questionnaires
Time frame: At days 1, 4 and 11.
Whole gut transit time (h) by the Blue poop challenge
Contact information is provided by the study sponsor or research team.
Laval University
Other
Acronym: GutMilk
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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