The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

Body Weight Clinical Trial

Official title:

The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04399460
• Other study ID #: DFC_LTDairy_2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 93
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI: = 27 and = 34.9 kg/m2

• Fasting serum glucose: = 7 mmol/L

• Low =1 serving of dairy consumption

• Waist circumference >88cm (women) and >102cm (men)

• Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.

• Willing to maintain current dietary supplement use throughout the trial. On test days, participant agrees not to take any dietary supplements until dismissal from the study. Failure to comply will result in a rescheduled test visit.

• Willing to abstain from alcohol consumption for 24 h prior to all test visits.

• Willing to avoid vigorous physical activity for 24 h prior to all test visits.

• Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator

Exclusion Criteria:

• Fasting blood glucose > 7 mmol/L

• Triglycerides = 2.3 mmol/L

• Smoking tobacco products and marijuana

• Thyroid problems

• Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.

• Presence of gastrointestinal disorder or surgeries within the past year.

• Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement.

• Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months.

• Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal

• Unwillingness or inability to comply with the experimental procedures

• Known intolerance, sensitivity or allergy to dairy products

• Consumption of protein powders/protein supplements

• Extreme dietary habits

• Uncontrolled hypertension as defined by the average blood pressure measured at screening.

• Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity

• Excessive alcohol intake

• Restrained Eaters

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Overweight or Obesity

Intervention

Other:
• Dairy-based commercially available food products
Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses
• Restrictive Eating
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

Locations

Country	Name	City	State
Canada	Mount Saint Vincent University	Halifax	Nova Scotia
Canada	Department of Nutritional Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Mount Saint Vincent University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal Collection	Gut microbiome profiling	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in blood glucose levels	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in fasting insulin (µIU/mL) levels in the blood	Each participant will attend 3 sessions in total	Change from baseline at 12 weeks
Other	Change in gut hormone levels measured in the blood	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in triacylglycerol level (mg/dL)	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in HbA1c (mmol/mol)	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in red blood cells fatty acids	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in resting metabolic rate	Each participant will attend 3 sessions in total measured by Indirect calorimetry	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in short-chain fatty acids in the blood	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in waist and hip circumference in cm	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Other	Change in lean body mass percentage measured by BodPod	Each participant will attend 3 sessions in total	Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Primary	Change in body weight	Each participant will attend 8 sessions biweekly in total	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.