Reducing Risk of Diabetes & Cardiovascular Disease by Diet and Lifestyle Modification
Dr. Mirjam Vente
Unilever R&D Vlaardingen
The Netherlands
Introduction
• Unilever and R&D
• Trends: changing dietary habit, increased prevalence of diabetes.
• Role of diet and lifestyle modification in prevention of diabetes
• Claims in area of blood glucose
• Summary and recommendation
How is your
blood glucose ?
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Trend: changing food consumption pattern
in India
• Total food grain consumption projected to decrease
• Shift from coarse cereals to “superior” cereals like rice and wheat
• Increased consumption of oil, sugar, fruits and vegetables
���� Increased calorie intake
Trend: increased prevalence of diabetes
(source: 5th diabetes Atlas, IDF)
Facts. •One fifth of all adults with diabetes live in SEA•Currently 8.3% of people in India have diabetes (underestimation)•50% of people are unaware•14.5% of all deaths in India are attributable to diabetes
Trend: consumers regard diabetes as a condition – not a serious disease
Juutilainen A, Diabetes Care 2005
CHD mortality
risk
Diabetes
History of myocardial
infarction
Diabetes + history of
myocardial infarction
No disease history
diabetes: Same CHD Risk as Heart Attack Sufferers!!
Message: Diabetes is Serious
Lifestyle Modification Reduces Risk of Diabetes: India
Source: Knowler WC, NEJM 2002
Indian Diabetes Prevention Programme:
• 3234 middle-aged overweight subjects with IGT
• Lifestyle intervention: • 150 min physical activity per week,
7% weight loss.
• Average follow up 2.8 years
• lifestyle modification reduces diabetes risk by 58%
Also demonstrated in Western population (Toumilehto et al. 2001)
STOP-NIDDM•Acarbose (drug) inhibits enzymes that are needed to digest carbohydrates and reduces PPG.•Multi-site intervention study, pre-diabetic subjects receiving acarbose (3x/day) or placebo for 3.5 years•Acarbose reduced conversion of pre-diabetes to T2DM (from 42% to 32%)• Acarbose was associated with reduced risk of CVD (from 4.7% to 2.2%)
Chaisson et al. 2002; 2003
Role of PPG in Diabetes & CVD Risk
Message: You are in Control
• Lifestyle modification reduces risk of diabetes.
• Lifestyle modification includes:
• Physical activity
• Weight loss
• Diet
• Lower saturated fat intake
• Increase in fibre intake
What are opportunities with food?
• With focus on carbohydrates, whole grain, fibre.
Low GI / GL Diets are Associated with Reduced Risk of Diabetes
37•Meta-analysis of 37
prospective cohort studies measuring GI / GL and chronic disease risk
•Positive associations for
• Diabetes: RR 1.4
• Heart disease: RR 1.25,
•GI>GL
• GI of contributing foods was more important then level of carbohydrate intake
•Similar results for whole grains and cereal fibre
Barclay A W et al. Am J Clin Nutr 2008;87:627-637; Priebe, 2009 Thesis
Rice associated with increased risk of diabetes
• Meta-analysis of 4 prospective cohort studies (7
data points) measuring rice consumption and chronic disease risk
• Higher white rice consumption was associated with a significantly elevated risk of T2DM
BMJ 2012;344:e1454
Dose response relation in white rice consumption and risk of diabetes.
• For each serving per day increment of white rice consumption, the relative risk was 1.11 (1.08 to 1.14; P for linear trend<0.001).
BMJ 2012;344:e1454
Low GI / GL diets favorably changes markers of diabetes
•Meta-analysis of 45 controlled dietary intervention trials on GI and markers of diabetes
•Lower glycemic index (GI) diets reduced both fasting blood glucose (BG) and glycated proteins
•Effects greater in persons with poor fasting BG
Livesey et al. Am J Clin Nutr 2008;87:258-268
Gaps in knowledge
• Observational studies have shown an association between GI/GL, whole grain, fibres and reduced risk of diabetes.
• Observational studies show association � not causality
• No clear distinction possible between studies on GI / whole grains and diabetes.
• Mechanism of action dietary fibres not clear; no consensus whether it soluble or insoluble fibres that exert the positive effect.
• Several products show reduction in post-meal blood glucose.
• Lack of intervention studies evaluating effect of dietary intervention on risk of diabetes in general population
What can we claim now?
Interplay of Research & Claims
Desired/possible claims:
• Motivating• Credible
• True• Legal
Agent selection
Test design
Marketeers
Scientists
Regulators
Lawyers
Competitors
Problems & Issues in the Claims Game
From Mela, Lipid Technology 2007
Research and data analysis• Inappropriate/unfair design or control treatment• Test product not representative of ‘real’ product
Dose, matrix not same Different/unknown material specification or handlingNo evidence of bio-functionality after processing and storage
• Statistics!Failure to assess treatment vs control effect in single analysisInappropriate (or no) handling of baseline bias (ANCOVA)Focus on (random) single time points vs total effect Post-hoc ‘responder’/’non-responder’ analyses
Data interpretation and use
• Percentages, ratios mask actual (small) effect • Statistical but not practical significance• Claim of “X” substantiated by data from “Y”• Shifting claims and support due to inconsistent outcomes• Selective presentation of data and treatments • Negative outcomes explained away, ignored, undisclosed
EFSA Assessment of Blood Glucose Claims: Reading Between the Lines so Far…
Key issues
• Lowering PPG response may be considered a beneficial physiological effect as long as insulin responses are not disproportionally increased.
• PPG is not an established risk factor for disease risk reductionclaim (like cholesterol).
• Characterization of constituent/food (eg ‘generic ingredients [fibres, GI], energy density, etc)
• Appropriate control/comparison (eg proteins, fibres, whole foods)
• ‘Comparative’ claims especially difficult for macronutrients and whole foods
©Unilever 2010
Summary and recommendations � It is in Your Hands
summary
•Lifestyle modification is associated with reduced risk of diabetes.
•Opportunities with food to reduce post prandial blood glucose response
•Awareness of consumers on diabetes and it’s complications needs to increase.
•Claims on products need to be based on proper scientific bases.
Scientific recommendations
•Further establish health
relevance of lowering PPG by
long term intervention studies in
general population
• showing effect of diet on glucose tolerance and risk of diabetes in general population
Acknowledgements
Marjan Alssema
Hanny Boers
Ester de Jonge
Katrina MacAulay
Richa Mattu
David Mela
Harry Peters
Peter Zock
Questions?
Backup
…Some Biology…
Blood glucose (BG) = glycemia;
• high blood glucose = hyperglycemia
Blood glucose is regulated by Insulin a hormone that regulates carbohydrate and fat
metabolism by regulating uptake of glucose from the blood into tissues
Diabetes mellitus is a chronic metabolic disease with high blood glucose.
• Type 1 diabetes: Body does not produce enough insulin
• Type 2 diabetes (T2DM): Cells do not respond well enough to insulin produced: insulin
resistance
Impaired glucose tolerance (IGT) is an intermediate stage of diabetes progression
defined as high blood glucose after standard glucose load (OGTT). This condition can be reversed by a healthy lifestyle (diet, exercise, reducing body weight) and
diabetes will not progress.
Blo
od G
lucose
Normal
Pre-Diabetes
Time
T2DM
Carbohydrates and Glycaemic Index
• Glycaemic index (GI): the postprandial blood glucose response of carbohydrate food compared with a reference food (either glucose or white bread)
• Glycaemic load (GL): overall glycaemic effect of the diet – taking into account the level of carbohydrates
composition matrix
• Fibres, starch,
sugars, specific
amino acids and proteins etc. ….
GI depends on
• Particle size
• Format
• Preparation
Criticality of illnesses from consumer’s view27
Life ThreateningSudden and disruptive;little controlCan only be cured; cannot be managed
Cause disruption of order in everyday lifeOffer little controlCan only be cured; cannot be managed
At an overall level, these set of diseases do
not cause much disruption in my everyday
life and nor are they seen as life threatening in a big way.. This is owing to the fact, that
consumers feel these are manageable, one
way or the other.
Speaking of Diabetes, mostly consumers
refer to the disease as ‘Sugar’ and hence,
there is a common perception that reducing
intake of sugar in one’s diet prevents
diabetes
Consumers also feel that:
•Diabetes can be controlled / cured with the
help of medicines & insulin injections
• Diabetes is mostly hereditary � risk is felt to be higher if diabetes exists in the family
background
•An active lifestyle (staying on the go,
exercising, eating less oily food) helps
prevent diabetes
Diseases which can be managed or controlled
The feeling that Diabetes can be controlled is what makes consumers a little indifferent to the disease
For most, the solution is as simple as reducing sugar content in one’s diet
The feeling that Diabetes can be controlled is what makes consumers a little indifferent to the disease
For most, the solution is as simple as reducing sugar content in one’s diet
Source: Tuomilehto NEJM 2001; 344:1343
Lifestyle modification reduces risk of diabetes: Finland
Finnish intervention study:
• 522 middle-aged overweight subjects with IGT
• Lifestyle intervention: • physical activity, weight loss,
increase fibre, reduce (saturated)
fat intake.
• Average follow up 3.2 years
• Incidence of diabetes after 4 yrs was :• 23% in control group
• 11% in lifestyle group.
• lifestyle modification reduces
diabetes risk by 58%
Whole grains and cereal fibres reduce risk of diabetes.
•Meta-analysis shows that both whole grains and cereal fibres reduce risk of diabetes.
•Cereal fibre intake can be considered a marker of whole grain consumption
• Whole grain contains more beneficial ingredients than fibres alone
Whole grain consumption
Cereal fibre consumption
Source: Priebe, 2009; thesis
Fibres favorably changes markers of diabetes
• Meta-analysis of 15 controlled dietary intervention trials on dietary fibres and
markers of diabetes in people with known T2DM• Results showed a mean reduction of fasting blood glucose of 0.85 mmol/L
and reduction of HbA1C of 0.26%
Forest plot for fasting glucose (mmol/l) Forest plot for HbA1C (%)Post et al. 2012
MoA of Dietary Fibre Not Clear
• Dietary fibre: diverse group of chemical
substances with a different physiological effects
• Soluble (e.g. pectins, psyllium)
– Intervention studies showing reduced blood glucose response
– Mostly acute studies – lack of long term intervention studies
• Insoluble fibre (e.g. cellulose)
– Observational studies showing link to reduced risk of diabetes.
• No consensus whether it is soluble or insoluble
fibres that mainly exert the protective effect.
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