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Diabetes MellitusNCT02544568

Effects of Standardized Meals on the Metabolic, Hormonal and Inflammatory Responses in Human

A study testing Meals in people with Diabetes Mellitus, run by Karolinska University Hospital at 1 site in Sweden.

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

Meal composition is important for blood sugar levels in patients with diabetes. The aim of this study is to investigate if a meal composition of fat, protein and carbohydrate is important for the hormonal and inflammatory responses Patients with type 1 and type 2 diabetes and healthy controls will be included in the… Read more about this study

Who is it for?
Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Meals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteSweden
Study dates
Nov 2009to Feb 2016
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient with type 1 DM (age 20-75 years)
  • Patient with type 2 DM (diabetes duration more than 5 years, age 20- 75 years, BMI 26 - 33 kg/m2).
  • Healthy volunteers (age 20- 75 years).

Who cannot join

  • Heart failure - the New York Heart Association (NYHA) Functional Classification III-IV
  • Kidney failure - S-Creatinin mora than 200 micromol/L
  • Liver disease - Alanine aminotransferase (ALAT) more than 2 mikroKat/L

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

About this study

Official title: Effects of Standardized Meals With Different Compositions of Fat, Protein and Carbohydrate on the Metabolic, Hormonal and Inflammatory Responses in Human

Meal composition is important for blood sugar levels in patients with diabetes. The aim of this study is to investigate if a meal composition of fat, protein and carbohydrate is important for the hormonal and inflammatory responses Patients with type 1 and type 2 diabetes and healthy controls will be included in the study. At four different occasions the participants will receive lunch with the same amount of calories but different composition of fat, protein, carbohydrate and fiber. Blood samples will be taken before and after the meals. The participants will estimate their satiety. In addition participant will fill in questionnaires about their food habits and wellbeing.

This study is the first study to compare both hormonal and inflammatory responses, as well as psychological aspect of the meals, after meals with different composition. Results from this study will help to make recommendation about meal composition which is beneficial for patients with diabetes type 1 and type 2.

Read the detailed description

Food is an important part of human beings life. During most part of human beings history the shortage of food has been a problem. Today the shortage of food is unknown phenomena in the industrial countries. Instead human being is facing a challenge in obesity epidemic. The number of obese persons has increased since 1980 in all industrial countries. Today only 20 - 25 % of the population in the US has a normal body mass index (BMI). The populations in Europe and Asia are following the same trend. It is known that increased waist (in women > 80 cm and in men > 94 cm) are correlated to insulin resistance, especially in liver because of increased hepatic fat storage. Increased prevalence of obese persons is followed by increased prevalence of patients with impaired glucose tolerance with increased risk for diabetes type 2, cardiovascular disease and cancer.

It is known that impaired glucose tolerance and diabetes type 2 can be prevented efficiently with weight loss, reduced total intake of fat and carbohydrate, increased intake of fiber and physical activity. Three popular diets, 1) low fat, 2) low carbohydrate (high-protein and high-fat) and 3) low glycemic load, have recently received much attention. Long term studies of these different diets have shown inconsistent results. There is a discussion today if a better metabolic control is achieved with low-carbohydrate diet compared to low-fat diet in patients with diabetes type 2 compared to the diet recommended by Swedish National Food Administration. In regards of dietary composition, hyperglycemia and dyslipidemia is determined by the amount and quality of ingested carbohydrates and dietary fats. It has been suggested that postprandial hyperglycemia and hypertriglyceridemia triggers oxidative stress and causes inflammation, metabolic alterations associated with endothelial dysfunction.

An important aspect of satisfaction after a meal is the feeling of satiety. Subjective feelings of hunger are also obviously related to initiation of food behaviors such as intake of snacks. Neophobia, the fear of new or unfamiliar foods, can also be related to the success or failure of food related behavior change. These feelings of satiety are in turn related to factors such as blood glucose levels. Thus the effect of ingested macronutrients on the postprandial glycemic response is one potential mechanism by which foods may affect satiety. Compared to fats and proteins, dietary carbohydrates may have the greatest effect on postprandial glycemia and insulinemia, and may therefore elicit greater appetitive ratings several hours after consumption compared to lower-glycemic meals. Lately some neuroendocrine hormones (ghrelin, resistin etc) and adipokines (leptin and adiponectin) have received attention as regulators of satiety and plausible causes of obesity. The effect of high-fat, high-protein or low-carbohydrate meals on these hormones are not known.

The adverse effects of factors such as chronic stress and depression on general health have been documented for many decades. Apart from having an influence on specific health behaviors, other interacting influences such as general life stress appear to be related directly to alterations in pro-inflammatory and hemostasis processes. The physiological pathways by which psychosocial factors might exert both positive and negative effects on health are numerous and incompletely understood. However, examples of particular interest are findings that suggest that even in relatively healthy persons, chronic negative appraisals of minor life events (hassles) are associated with increased circulating levels of inflammatory factors, whereas persistent positive appraisals of minor life events (uplifts) are associated with decreased levels of such factors. It is thus important to consider general Quality of Life, as well as food-related quality of life together with health and taste attitudes and nutritional knowledge.

Finally the gender aspect is also of importance. Previously it has been presumed that the inflammatory and hormonal responses to different diets are the same in men and women. There are known biological and hormonal differences between men and women. One may question why women get heart infarction later in life compared to men and if the risk factors including inflammatory responses, cholesterol levels and other hormonal changes after different diets are the same in men and women.

The aim of this study is to compare the high-fat, high-protein and low-carbohydrate meal regarding post prandial glucose and triglycerides concentrations in blood as well as the fast inflammatory response, oxidative stress and appetite regulating hormones in healthy subjects and patients with diabetes. Gender differences will be investigated. In general this study will provide information on which meal compositions that are beneficial for patients with diabetes and healthy subjects. Another aim of this study is to investigate if the psychosocial aspect of the meal such as health locus of control, neophobia, satiety and food related Quality of Life is important for the hormonal responses after the meals.

Hypothesis :

  1. Meal with high concentration of fiber (15 g) is beneficial for metabolic control in patients with diabetes.
  2. Low-carbohydrate meal is beneficial for the metabolic control in patients with diabetes.
  3. High-fat meal results in hyperlipidemia which worsens hepatic insulin sensitivity and increases the oxidative stress.
  4. High-protein and high-fat meal give earlier satiety and lower blood sugar levels compared to high carbohydrate diet.
  5. The perception of the meal affects the metabolic control.

Design:

30 patients with type 1 (T1DM) and 30 patients with type 2 diabetes (T2DM)and 30 healthy Controls (HC) will be included in the study. At four different occasions the participants will eat lunch with different composition of fat, protein, carbohydrate and fiber. All groups are divided in subgroups of men and women. Healthy subjects will receive an oral glucose tolerance test before they are included in the study.

The composition of the meals is: Low-fat / high-carbohydrate meal (18 Eenergi % (E%) proteins, 28 E% fat and 54% carbohydrates), high-fat meal (18 E% protein, 50 E% fat and 31 E% carbohydrate), high-protein meal (40 E% protein, 30 E% fat and 30 E% carbohydrates) and low-fat / high-carbohydrate and high fiber (18 E% proteins, 28 E% fat and 54% carbohydrates and 15 gram of fibers).

Before the study and before the last meal we will measure the waist/hip ratio, BMI and body composition (Bioimpedance). Before the study the participant will document their daily meals during three days. Patients with diabetes should at the same time also document their blood sugar levels (7 times per day, fasting levels, levels before and 2 hours after lunch and dinner and before they go to sleep). Before the other occasions patients will measure their blood sugar levels during one day (7 times).

The participants will eat a standardized breakfast at home in the morning before participating in the study. They will eat one of following meals as lunch at 11:30 am: a low-fat and high-carbohydrate diet recommended by Swedish National Food Administration, a high-protein meal, a high-fat meal or a low-fat and high-carbohydrate diet with 15 g of fibers. At each occasions blood samples will be taken 30 minutes and 5 minutes before the lunch and on 30-minute intervals for the following four hours after the lunch. The blood samples will be analysed for hormones regulating blood sugar levels, appetite regulating hormones, marker of oxidative stress and markers of inflammation and endothelia dysfunctions. We have previously shown that insulin sensitivity in liver can be estimated measuring Insulin like Growh factor- I (IGF-I) and Insulin like Growth Factor Binding Protein-1 (IGFBP-1). These hormones will be analyzed in blood samples.

The participants will estimate their satiety and their desire to eat in parallel at the time blood samples are withdrawn. At each occasion participants will fill in forms about their general perception of the food and how they estimate their own health.

In case a participant do not follow throughout the whole study the results will be analyzed and used in group wise comparisons.

Being tested
Meals
Keywords
high fat, high protein, high carbohydrate, insulin, glucose
Medical subject headings
Diabetes Mellitus, Insulin Resistance

What participants receive

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

  • MealsOther

    At 4 different occasions the participants will receive meals with the same amount of calories and different composition of fat, protein, carbohydrate and fiber.The composition of the meals is: Low-fat / high-carbohydrate meal (18 E% proteins, 28 E% fat and 54% carbohydrates), high-fat meal (18 E% protein, 50 E% fat and 31 E% carbohydrate), high-protein meal (40 E% protein, 30 E% fat and 30 E% carbohydrates) and low-fat / high-carbohydrate and high fiber (18 E% proteins, 28 E% fat and 54 E% carbohydrates and 15 gram of fibers).

Study groups in NCT02544568
Study groupRoleWhat they receive
High-Carb MealExperimentalThe 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr) .
Receives: Other: Meals
High-Protein MealExperimentalThe 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr) .
Receives: Other: Meals
High-Fat MealExperimentalThe 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr) .
Receives: Other: Meals
High-Fibre MealExperimentalThe 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr).
Receives: Other: Meals

What is being measured

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

  1. Maximum plasma concentration [Cmax] of glucose and triglycerides

    The maximum plasma concentration of glucose and triglyceres after the meals

    Measured: 1 year

Secondary outcomes (5)
  1. Maximum plasma concentration [Cmax] of IGFBP-1

    The maximum plasma concentration of IGFBP-1 after the meals

    Measured: 2 year

  2. Maximum plasma concentration [Cmax] of marker of oxidative stress

    The maximum plasma concentration of markers of oxidative stress after the meals

    Measured: 2 year

  3. Maximum plasma concentration [Cmax] of inflammatory markers

    The maximum plasma concentration of inflammatory markers after the meals

    Measured: 2 year

  4. Maximum plasma concentration [Cmax] of appetite regulatory hormones

    The maximum plasma concentration of apetite regulatory hormones after the meals

    Measured: 2 years

  5. Maximum plasma concentration [Cmax] of glucagon

    The maximum plasma concentration of glucagon after the meals

    Measured: 2 years

Timeline

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

  1. First posted9 Sep 2015 (estimated)
  2. Study startNov 2009
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02544568
Sponsor's protocol ID
2007/801-32
Status last verified
Mar 2019
First submitted
26 Aug 2015
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Meals in people with Diabetes Mellitus, run by Karolinska University Hospital at 1 site in Sweden.

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 3 inclusion and 3 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 6 Mar 2019. 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 Sweden. 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?

Maximum plasma concentration [Cmax] of glucose and triglycerides (time frame: 1 year). 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 6 Mar 2019.

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