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Type 2 Diabetes MellitusNCT02491801

Form of Dairy Products on Satiety, Food Intake and Post-meal Glycaemia in Young and Older Adults

A study testing Dietary intervention in people with Type 2 Diabetes Mellitus and Obesity, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed study is planned to determine the potential role for regular fat dairy products in short-term metabolic control in younger and older adults and the metabolic flexibility in response to food components, which are areas that have not yet been explored. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus, Obesity
What is being tested?
Dietary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteCanada
Study dates
Mar 2015to 21 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy, non-smoking male and female participants aged 20-30 and 60-70 years old
  • Young adults with body mass index (BMI) of 18.5-24.9 kg/m2 (normal weight) and older adults with BMI between 18.5-29.9 kg/m2 (normal/overweight).

Who cannot join

  • Diabetic
  • Individuals on medication affecting appetite
  • Lactose-intolerant or allergic to dairy (including milk, yogurt, and cheese)
  • Breakfast skippers
  • Gastrointestinal problems
  • Individuals on an energy-restricted diet

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Department of Nutritional Sciences, FitzGerald Building

    Toronto, Ontario, M5S 3E2

Other trials in Canada

About this study

Official title: The Effect of Solid, Semi-solid and Liquid Dairy Products on Satiety, Food Intake and Post-meal Glycaemia in Young and Older Adults

The proposed study is planned to determine the potential role for regular fat dairy products in short-term metabolic control in younger and older adults and the metabolic flexibility in response to food components, which are areas that have not yet been explored. Subjects would be served with solid (cheese), semi-solid (yogurt) and liquid (milk) dairy products and skim milk (control) and water (non-caloric control) in three separate studies.

Read the detailed description

Over the last 30 years, overweight and obesity have become characteristic of the majority of Canadians. Approximately 60% of adults in Canada are overweight or obese. The Canadian Health Measures Survey, conducted during 2007-2009, estimated prevalence of metabolic syndrome at 19.1% in the adult population. In addition, according to the 2010 Canadian Community Health Survey, 18.1% of Canadian adults have been reported obese. Along with the health burden, it has also brought about an estimated economic burden of $ 4.3 billion annually in 2001, which has likely doubled as of today.

Metabolic syndrome and type 2 diabetes occur concurrently with insulin resistance marked by increased blood glucose levels at fasting and postprandial, glycosylated blood proteins leading to arterial damage, inflammation and comorbidities such as cardiovascular disease. Despite increased consumer interest in consuming foods that may help treat or prevent obesity and diabetes, effective countermeasures against metabolic diseases have yet to be established. Thus, food products that are capable of controlling parameters of metabolic diseases including blood glucose, insulin levels and food intake are in urgent need of investigation and identification. Dairy products are believed to hold this potential because of their functional physiological properties.

There have been many observational and long-term clinical studies showing that regular consumption of dairy products correlate with a better body composition and a lower incidence of obesity and type 2 diabetes. Studies have also found that dairy proteins are more satiating than other types of proteins, and that they are effective in lowering the increase in glycemic response after high GI food intake, but most studies have been done in isolated proteins. Hence, the role of dairy proteins, in their conventional food form reflecting usual intake, on food intake and glycemia and their interactions with these metabolic diseases is of interest.

From short-term studies done in our lab, the investigators have shown that dairy products can bring about benefits in glycemic control and food intake when consumed before or within ad libitum meals, which can be achieved by both insulin dependent and independent mechanisms. The investigators have shown that fluid milk products and yogurt improve post-meal glycemic excursions when consumed before or within an ad libitum meal by healthy young adults. Except the yogurt study conducted in our lab, there have been no other studies reporting the role of solid or semi-solid dairy products consumed before a meal, within a meal, immediately post-meal or as between meal snacks on glycemia and appetite control. Our study on yogurt showed that yogurts, especially those with high protein to carbohydrate ratio, reduced pre-meal glucose incremental areas under the curve. Further studies on solid and semi-solid dairy need to be conducted because milk, like other caloric beverages, lead to calorie accumulation if consumed before or with a meal even though it provides more nutrients, lowers post-meal blood glucose excursions and leads to greater post-meal satiety in young adults.

Moreover, the evidence appears to be relatively consistent with respect to a beneficial role of low-fat dairy products in the prevention of type 2 diabetes (T2D), however, the role of regular/high-fat dairy is less clear. A number of cross-sectional and prospective epidemiological studies have identified a positive association between the intake of dietary fat and the risk for development of either insulin resistance or T2D20. More research is needed to better understand the role of regular-fat dairy products on food intake as well as of glycemic control.

Three studies are proposed:

  • Study 1 investigates the effects of 2-servings of pre-meal regular fat; cheese, yogurt and milk on food intake at 2 hours, satiety and glycemia in normal weight young adults (20-30 yrs) and normal weight/overweight older adults (60-70 yrs).
  • Study 2 investigates the effects of 1-serving of pre-meal regular fat; cheese, yogurt and milk on satiety and glycemia in normal weight young adults (20-30 yrs) and normal weight/overweight older adults (60-70 yrs).
  • Study 3 investigate the effects of 1 serving for pre-meal regular fat; cheese, yogurt and milk on food intake at 15 min and 30 min, satiety and glycemia in normal weight/overweight older adults (60-70 yrs).
Keywords
Dairy, Milk, Yogurt, Cheese, Postprandial glycaemia, Satiety, Food Intake, Elderly, Prevention and Treatment
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02491801
Study groupRoleWhat they receive
3.25% M.F. MilkExperimental3.25% M.F. Milk
Receives: Other: Dietary intervention
Greek YogurtExperimentalGreek Yogurt (2% M.F.)
Receives: Other: Dietary intervention
Cheddar CheeseExperimentalRegular Fat Cheddar Cheese
Receives: Other: Dietary intervention
Control 1ExperimentalSkim milk
Receives: Other: Dietary intervention
Control 2ExperimentalFiltered water, calorie-free control
Receives: Other: Dietary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Glucose (Study 1, 2 and 3)

    Blood glucose (mmol/L) is measured by using finger prick capillary blood samples.

    Time frame and frequency vary for each study.

    Study 1: Baseline measure (0 minute) then every 15 minutes up to 120 min (post-treatment), 8 times; 140 to 170 min (post-meal) every 30 mintes, 2 times . A total of 10 times

    Study 2: Baseline measure (0 minute) then post-treatment every 15 minutes up to 90 minutes and last measure at 120 minutes. A total of 7 times.

    Study 3: Part 1: Baseline measure (0 minute) then every 15 minutes up to 30 minutes post-treatment, then 50 minutes and every 15 minutes until 125 minutes. A total of 9 times.

    Part 2: Baseline measure (0 minute) then at 15 post-treatment and, 35 and 50 minutes post-meal. A total of 4 times

    Measured: Post-treatment and post-meal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion21 Feb 2018
  4. Study completion21 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02491801
Sponsor's protocol ID
DFC_31323
Status last verified
Nov 2020
First submitted
2 Jul 2015
Last updated
3 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dietary intervention in people with Type 2 Diabetes Mellitus and Obesity, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Glucose (Study 1, 2 and 3) (time frame: Post-treatment and post-meal). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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