Dairy Consumption for Weight Management

Overseen By Shekoufeh Salamat, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Prebiotics, Probiotics, others

Disqualifiers: Smoking, Thyroid problems, CVDs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

240 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using any prescription or non-prescription drugs, herbal or nutritional supplements that might affect the study's outcome, you may be excluded from participating.

What data supports the effectiveness of the treatment Increasing Dairy intake for weight management?

Research suggests that consuming dairy foods may help with weight management, especially when combined with a moderate calorie-restricted diet. Studies indicate that higher dairy intake is linked to increased weight loss and maintenance of lean body tissue, possibly due to effects on fat breakdown and appetite regulation. ^{1 2 3 4 5}

Is increasing dairy intake safe for weight management in humans?

Research on dairy consumption for weight management shows it is generally safe for humans, with studies indicating no significant adverse effects on body weight or fat gain. However, the effectiveness of dairy for weight management varies, and more research is needed to understand its full impact. ^{1 2 6 7 8}

How does increasing dairy intake differ from other treatments for weight management?

Increasing dairy intake is unique because it focuses on incorporating more dairy foods into the diet, which may help with weight management by promoting fat loss and maintaining lean muscle during calorie restriction. This approach leverages the potential benefits of dairy components like calcium and whey protein, which may influence appetite regulation and fat metabolism, unlike other treatments that might focus solely on calorie reduction or exercise. ^{1 2 7 9 10}

What is the purpose of this trial?

The goal of this study is to examine how regular dairy intake affects body weight, body composition, and metabolic health in overweight and prediabetic adolescents (ages 14-17) and older adults (ages 60-75) over a six-month period. We are inviting eligible individuals to participate in this study at the Nutrition Intervention Center, Department of Nutritional Sciences, University of Toronto, St. George campus. Participants will be randomly divided into two groups. The intervention (high-dairy) group will consume three servings of dairy per day (milk, yogurt, and cheese) before breakfast, lunch, and dinner. The control (low-dairy) group will continue their usual diet, keeping dairy intake less than one serving per day. Participants will have biweekly sessions with a registered dietitian to monitor their dietary intake and ensure compliance with their assigned group. In addition, they will visit the Nutrition Intervention Center at week 0, week 12, and week 24 for anthropometric and body composition assessments (weight, height, waist circumference, blood pressure, lean mass, fat mass), glycemic and metabolic markers (fasting blood glucose, insulin, HbA1c, lipid profiles in seniors, and appetite hormones in adolescents). Each assessment visit will take approximately 4 hours. Before each visit, you will be asked to fast for 12 hours overnight, maintain your usual diet and sleep patterns, and avoid exercise and alcohol consumption the day before. Your participation in this study will help us better understand the role of dairy in metabolic health and may contribute to improved dietary recommendations for adolescents and older adults. You will be compensated for your time and travel expenses.

Research Team

G Harvey Anderson, Ph.D.

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for overweight and prediabetic adolescents aged 14-17, as well as older adults aged 60-75. Participants must be willing to follow a high or low dairy diet and attend biweekly sessions with a dietitian. They should also be able to visit the Nutrition Intervention Center every six weeks for health assessments.

Inclusion Criteria

I am either 14-17 years old or 60-75 years old.

My BMI is slightly above average for my age group.

I can avoid alcohol for 24 hours before each test visit.

Exclusion Criteria

I am not taking any drugs or supplements that could affect the study results.

I am not pregnant, breastfeeding, and have been postmenopausal for over a year or I am not on hormonal treatments.

Fasting BG ≥ 7mmol/L

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are divided into high-dairy and low-dairy groups, with biweekly sessions with a dietitian and assessments at weeks 0, 12, and 24

24 weeks

3 visits (in-person) at weeks 0, 12, and 24; biweekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Increasing Dairy intake

Trial Overview The study tests how three daily servings of dairy affect weight, body composition, and metabolic health over six months compared to usual diets with minimal dairy. It involves regular check-ins and detailed health assessments at the University of Toronto.

Participant Groups

Group I: Intervention arm, Dairy Group- Seniors Experimental Treatment 1 Intervention

The participants in the intervention group will consume 3 servings of dairy per day.

Group II: Intervention arm, Dairy Group- Adolescents Experimental Treatment 1 Intervention

The participants in the intervention group will consume 3 servings of dairy per day.

Group III: Control arm, Low Dairy- Adolescents Active Control 1 Intervention

The participants in the control group will be asked to maintain their usual diet and dairy intake, involving consuming ≤1 serving of dairy per day.

Group IV: Control arm, Low Dairy- Seniors Active Control 1 Intervention

The participants in the control group will be asked to maintain their usual diet and dairy intake, involving consuming ≤1 serving of dairy per day.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of dairy foods and dietary calcium in weight management. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Associations between dairy consumption and body weight: a review of the evidence and underlying mechanisms. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Effects of dairy intake on weight maintenance. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Association of dairy intake with weight change in adolescents undergoing obesity treatment. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Calcium and dairy product modulation of lipid utilization and energy expenditure. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of increasing dairy calcium intake of adolescent girls on changes in body fat and weight. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Dairy consumption and overweight and obesity: a systematic review of prospective cohort studies. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Dairy products and total calcium intake at 13 years of age and its association with obesity at 21 years of age. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Low-fat dairy intake and body weight and composition changes in college students. [2023]

10. Spain pubmed.ncbi.nlm.nih.gov

THE INCREASE OF DAIRY INTAKE IS THE MAIN DIETARY FACTOR ASSOCIATED WITH REDUCTION OF BODY WEIGHT IN OVERWEIGHT ADULTS AFTER LIFESTYLE CHANGE PROGRAM. [2022]