The Effect of Dairy Intake on Body Weight and Composition and Metabolic Health in Adolescents and Seniors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-80
SponsorUniversity of Toronto
About 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 obese adolescents (ages 15-18) and older adults (ages 60-80) over six months. We are inviting eligible individuals to participate in this study at the Nutrition Intervention Center, Department of Nutritional Sciences, University of Toronto. Participants will be randomly divided into two groups. The intervention (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 to less than one serving per day.
Participants will have biweekly sessions with a registered dietitian to be guided to follow Canada's Food Guide, monitor their dietary intake and ensure compliance with their assigned group. In addition, they will visit the Nutrition Intervention Center at weeks 0, 12, and 24 for anthropometric and body composition assessments (weight, height, waist circumference, blood pressure, lean mass, and fat mass), resting metabolic rate, (gait speed, grip strength, and chair stand test just for older adults) and blood markers (fasting blood glucose, insulin, C-peptide, HbA1c, lipid profiles, and inflammatory markers). Each visit will take approximately 4 hours.
Before each visit, the participants will be asked to fast overnight for 12 hours, maintain their usual diet and sleep patterns, and avoid exercise and alcohol the day before. The participants will be compensated for their time and travel expenses.
Our secondary objective is to compare the effects of dairy and plant-based alternative products on blood sugar and appetite regulation in adolescents and older adults. Participants will be asked to come to the Nutrition Intervention Center on 3 separate occasions: once for an in-person screening lasting approximately 30 min and 2 times for study visits lasting approximately 2.5 hrs each. The entire study will take at least 2 weeks to complete. You will be asked to fast for 12 hrs (overnight) before each study visit. You will also be instructed to maintain the same dietary and sleep patterns and refrain from exercise and alcohol consumption on the days before the study visits. During these study visits, you will be asked to consume either a dairy or a plant-based alternative product as well as a pizza meal. You will periodically fill out questionnaires rating your feelings and perceptions, and provide blood samples through finger pricks and intravenously through your forearm to measure blood sugar, insulin, hormones, and amino acids. You will be compensated for your time and travel expenses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 15-18 years old (adolescents) or 60-80 years old (seniors)
BMI z-score >+1SD, <+2SD (adolescents) or BMI 25-34.9 kg/m2 (seniors)
Waist circumference > 80 cm for women and > 94 cm for men (seniors)
FBG 5.6-6.9 mmol/L (prediabetes)
Disqualifiers
Fasting BG ≥ 7 mmol/L
Blood pressure systolic ≥ 130mmHg or diastolic ≥ 80mmHg (adolescents) or systolic ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg
Smoking (tobacco and/or cannabis product use in the last 6 months)
Thyroid problems
Trial design
Design model
Parallel
Treatments tested in this trial
Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study)
Other interventionParticipants aged 15-18 and 60-80 years who are randomly assigned to the intervention group will follow Canada's Food Guide and consume 3 servings of dairy (milk, yogurt, cheese) per day for 24 weeks.
Dairy (short-term study)
Other interventionThe dairy products that participants will be required to consume include: 1) Trial 1: 2% cow's milk; 2) Trial 2: dairy yogurt.
Counselling to follow Canada's Food Guide (long-term study)
Other interventionParticipants will be instructed to follow Canada's Food Guide.
Plant-based alternative (short-term study)
Other interventionThe plant-based products that participants will be required to consume include: 1) Trial 1: soy beverage; 2) Trial 2: plant-based yogurt;
Treatment groups
240 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: High Dairy - Adolescents (long-term study)Experimental treatment 1 intervention
Group B: Low Dairy- Adolescents (long-term study)Active comparator 1 intervention
Group C: High Dairy - Seniors (long-term study)Experimental treatment 1 intervention
Group D: Low Dairy- Seniors (long-term study)Active comparator 1 intervention
Group E: Dairy arm - Adolescents (short-term study)Experimental treatment 1 intervention
Group F: Plant-based alternative - Adolescents (short-term study)Experimental treatment 1 intervention
Group G: Dairy arm - Seniors (short-term study)Experimental treatment 1 intervention
Group H: Plant-based alternative - Seniors (short-term study)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Body Fat Mass (kg)
Body Fat Mass (BFM) is the primary outcome in the long-term study of the senior group. It will be measured using bioelectrical impedance analysis (BIA).
Time frame
BFM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).2
Lean body mass (Kg)
Lean body mass (LBM) is the primary outcome in the long-term study of the senior group. It will be measured using bioelectrical impedance analysis (BIA).
Time frame
LBM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).3
Body Mass Index (BMI) z-score
BMI z-score, the primary outcome in the long-term study of the adolescent group, is an age- and sex-adjusted measure of BMI in adolescents. It will be calculated using height and weight measurements and interpreted using WHO growth charts and percentiles.
Time frame
BMI z-score will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).4
Blood Glucose (mmol/L) (short-term study)
Blood glucose, the primary outcome in the short-term studies of adolescents and seniors, will be measured via finger-prick using a glucometer at 0, 5, 20, 35, 50, 65, 95, 125, and 145 minutes after treatment consumption.
Time frame
Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.Secondary outcomes
1
Fasting blood glucose (FBG) (mmol/L)
FBS will be measured to assess glycemic control in long-term studies of adolescents and seniors. It will be measured using a finger-prick blood sample and a glucometer after a 12-hour overnight fast.
Time frame
FBS will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).2
HbA1c (%)
HbA1c measures average blood glucose levels over the past 2-3 months. It will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Time frame
HbA1c will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).3
Insulin (µU/mL)
Insulin levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Time frame
Insulin will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).4
C-Peptide (pmol/L)
C-peptide levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Time frame
C-Peptide will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).Other outcomes
1
Dietary intake
Dietary intake and adherence to Canada's Food Guide will be assessed using a 3-day food record, the modified Canadian Food Intake Screener (mCFIS), the Canadian Eating Practices Screener (CEPS), and a knowledge, attitude, and practice questionnaire (KAPQ).
Time frame
Three-day food records will be collected every six weeks; the mCFIS and CEPS will be administered monthly; and the KAPQ will be administered at weeks 0, 12, and 24.Sponsors and contacts
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Source ClinicalTrials.gov