Dairy-based commercially available food products
OtherFull-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses
NCT Number: NCT04399460
The proposed study looks at the effect of long-term diet modification with or without full-fat dairy products or restrictive eating on body weight, body composition and cardiometabolic markers in healthy overweight/obese men and women.
This study is active but is not currently recruiting participants.
Notify Me30 year–50 year
All sexes
Interventional
Not applicable
Mount Saint Vincent University, Halifax, Nova Scotia, Canada
A total of 93 males and females will participate in the study at the University of Toronto.
At the beginning and after 12 weeks, body weight, composition will be measured through Bodpod scans. Resting metabolic rate and thermogenesis will be measured by indirect calorimetry. Also, fecal samples will be collected for gut microbiome profiling along with blood for glucose, insulin, hormones, triacylglycerol, HbA1c, short-chain fatty acid, red blood cells and FGF21. Urine samples will be collected throughout the study.
A followup session at 16 weeks will reassess previous measures.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses
Dietitian will assist with 500 kcal/day reduction through limiting of macronutrients 45-65% energy from carbohydrates 20-35% energy from fat 10-35% energy from protein
Time frame: Starting at the beginning of the study 0 week then biweekly for 7 sessions up to 12 weeks with a followed up at 16 weeks.
Each participant will attend 8 sessions biweekly in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Gut microbiome profiling
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
Time frame: Change from baseline at 12 weeks
Each participant will attend 3 sessions in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total measured by Indirect calorimetry
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
Time frame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Each participant will attend 3 sessions in total
University of Toronto
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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