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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Claim

NUTRITION (Sound Basis)

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