1. The document discusses opportunities for weight management in consumer food and beverage products. It outlines several key consumer trends in weight management, including products that are lower calorie, contain active ingredients like protein or fiber, and emphasize good taste. 2. The document then reviews EFSA criteria for health claims related to weight management. It discusses the need for human intervention studies, appropriate outcome measures like changes in body weight or composition, and validated target populations. 3. Finally, the document provides examples of EFSA opinions on weight management claims, including favorable opinions for meal replacement products and unfavorable opinions due to lack of evidence or precision in claims. It emphasizes the importance of careful study design and formulation of health

1. Opportunities for weight
management in the market
Rianne Ruijschop, PhD

2. Importance of weight management
in the market
• Consumer trends in weight management:
- low calorie and indulgent
- healthy snack alternatives (e.g. „soup-like chewable shots‟)
- natural (no artificial sweeteners)
- inclusion of active ingredients (green tea, fibre, probiotics, protein)
- rehydration (thirst-quenching during sports) & drinkability (nutrient-density)
- reduced calorie next to no calorie
Most important: Good Taste!
• Next to the obese and overweight population (promoting weight loss
and preventing weight regain) the elderly (preventing weight loss and
maintaining muscle mass) are target as well.
• Ongoing discussion on how to position weight management in the
market (shift from weight management towards balanced nutrition?)
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3. EFSA criteria for health claim substantiation
• Draft guidance on the scientific requirements for health claims related
to appetite ratings, weight management, and blood glucose
concentrations (EFSA Panel on Dietetic Products, Nutrition and
Allergies (NDA); March, 2011)
• Mainly submitted under Article 13.1: Generally accepted health claims
Primary importance:
• Sufficient characterization of the food constituent
• Quantity and pattern of consumption achievable in balanced diet
• Study population is the target group
• Human intervention studies with appropriate outcome measures available
• Claimed effect specific enough to be testable and measurable
• Claimed effect is considered a beneficial physiological effect
Secondary:
• Supporting evidence from animal/in-vitro studies
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4. EFSA and weight management
What is target population?
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5. EFSA and weight management
What is benefit? What are validated measurements?
1. Appetite ratings and subsequent energy intake
• Claims on increased satiety and/or reduced sense of
hunger/appetite
• Claims on reduced energy intake
- sustained effect after chronic consumption (one month)
- comparative claims (test vs. control food)
- changes in appetite ratings could be used as evidence for a
mechanism
- changes in certain biochemical markers (e.g. CCK) may support
the mechanism of action
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6. EFSA and weight management
2. Weight management
• Claims on body weight maintenance/loss
• Claims on body weight maintenance after weight loss
• Claims on the reduction of body fat (abdominal fat)
• Claims on the increase of lean body mass
- appropriate duration of intervention (three months and six-month follow-up after
weight loss)
- inclusion of dietary conditions of intervention (e.g. under energy-restriction, ad
libitum)
- measures of body composition (reduction of body fat mass)
- measures of fat oxidation (increased fat oxidation)
- measurements of changes in abdominal/visceral fat and body shape using
appropriate methods (e.g. imaging techniques)
- measures of energy expenditure may support the mechanism of action
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7. EFSA and weight management
3. Blood glucose and insulin concentrations
• Claims on the reduction of post-prandial blood glucose responses
• Claims on (long-term) blood glucose control
• Claims on increased insulin sensitivity
- measures of both glucose and insulin concentrations in the blood are required
- claims have been provided for replacement by non/low-digestible
carbohydrates, intense sweeteners and sugar alcohols
- appropriate duration of intervention (at least three months (improved blood
glucose control)
- measures of glycosylated haemoglobin (HbA1c)
- measures of AUC plasma glucose concentrations after a standard oral glucose
tolerance test (OGTT) is supportive
- measures of e.g. fasting insulin, homeostatic model assessment (HOMA), and
the quantitative insulin sensitivity check index (QUICKI)
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8. EFSA and weight management
Current status?
• Favourable opinions:
- meal replacement and weight control
- dietary intake of protein and the growth or maintenance of muscle
mass
- specific dietary fibres related to blood glucose control, or weight
management
- the role of a range of sugar replacers (such as xylitol and sorbitol)
in lowering the increase of blood glucose levels after meals
- chromium and maintenance of normal blood glucose
concentrations
- ………..
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9. Meal replacement for weight control
• 1st weight management claim approved by EFSA (March, 2010)
- reduction in body weight
- maintenance of body weight after weight loss
• Characteristics of meal replacements: should contain a maximum of 250
kcal/serving; providing between 25% and 50% their energy in protein, not
more than 30% as fat, not less than 1g of linoleic acid (in the form of
glycerides), and at least 30% of the dietary reference values for adults of a
range of vitamins and minerals, and at least 500 mg of potassium per
meal
• The target population is assumed to be overweight subjects in the general
population who wish to reduce their body weight or maintain their body
weight after significant weight loss
• Claim wordings:
- Substituting two daily meals with meal replacements helps to lose weight
in the context of energy restricted diets
- Substituting one or two daily meals with meal replacements helps to
maintain body weight after weight loss
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10. EFSA and claim rejection
• Unfavourable opinions due to:
- lack of information to identify the substance on which the claim is
based (e.g., claims on “dietary fibre” without specifying the
particular fibre);
- lack of evidence that the claimed effect is indeed beneficial to the
maintenance or improvement of the functions of the body (e.g.
xanthan gum and increased satiety; L-lysine and an increase in
appetite leading to an increase in energy intake; claims on proteins
including multiple dietary manipulations);
- lack of precision regarding the health claim being made;
- lack of human studies with reliable measures of the claimed health
benefit;
- claims referring to food categories which were considered to be too
broad, such as “fruits and vegetables” and “dairy products” to be
linked to specific effects.
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11. To conclude:
no golden (single) formula for success but…
• Pre-study phase: define, and carefully formulate, your desired effect
and make it primary endpoint
• Study group is your target group
• Go for blinded RCTs
• Have your product characterized
• Adequate duration and dosage in line with intended consumption
• Ensure appropriate study power
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12. From concept to claim
PRODUCT
Working
FORMULATION
Health claim hypothesis of
underlying
mechanism
Verification Gastrointestinal
Human study model
In vitro study
SIMPHYD
In vivo screening
Selection of efficacy/ Demonstrate
ingredient with bioavailability efficacy in
highest potential Animal/human vitro
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13. Multi-targeted approach
I. Appetite modulating II. Optimising aroma, taste, III. Test productions
Ingredients & Concepts texture and mouth feel
• Sensory & ingredient induced/reduced • Hedonic appreciation / • Custom-designed foods
appetite/drinkability mood / reward for clinical intervention
• In vitro digestion (SIMPHYD+, cell lines) • Fat-replacement studies
• In vivo and human intervention studies • High protein food taste • Food-grade food
• Biomarker measurement (fMRI, • Sweetness optimization application and
hormone response, nutrient • Taste (bitterness) masking processing facilities
bioavailability, microbiota modulation) • Rich texture in low-cal foods
• Body composition • Low viscous protein foods
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14. Appetite modulating concepts
Sensory related appetite and satisfaction
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15. An example: Flavour release affecting
the consumer’s (emotional) state of mind
How do people “measure” the calorie content of a food
liquid
PP28 sweet
050726RR2 SIR of 5 Channels AP+
25.25 130.95
100
3.61e7
Flavour intensity [A.U.]
?
25.22
%
25.09
25.13
25.45
+
25.69
25.02
25.34
23.09 23.51 26.22
25.65 26.07
23.17 24.98
0 Time
23.00 23.25 23.50 23.75 24.00 24.25 24.50 24.75 25.00 25.25 25.50 25.75 26.00 26.25 26.50 26.75 27.00
1 min
solid
PP28 sweet
050726RR2 SIR of 5 Channels AP+
34.13 82.96
100
1.43e7
Flavour intensity [A.U.]
32.82
33.33
33.12
32.76
33.35
33.55
33.79
33.29 33.66
32.87 33.51 33.90
34.06
?
33.05
32.38 32.50
%
+
32.13 34.23
34.42
32.02
32.35
32.70
31.80 31.92
31.78 34.77
34.50
34.71
31.48
34.83 34.98
35.52
1 Time
31.00 31.50 32.00 32.50 33.00 33.50 34.00 34.50 35.00 35.50 36.00
4 min
Ruijschop et al., British Journal of Nutrition (2008), 99, 1140-1148 & thesis
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16. Flavour release affecting the
consumer’s (emotional) state of mind
30
As in: Low fat, low sugar
delta satiation VAS rating (mm)
20 * * *
As in: high fat,
Δ satiation
10 high sugar
0
0 1
4 2
9 3
15 4
25 5
30 6
35 7
45
-10 Time (min)
aroma ad lib. food
-20 stimulation consumption
-30
* sign. effect type of aroma stimulation on Δ satiation VAS ratingtrial (min)
Time after start (p≤0.10)
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17. Flavour release affecting the
consumer’s (emotional) state of mind
E.g. satiation
liquid
PP28 sweet
050726RR2 SIR of 5 Channels AP+
25.25 130.95
100
3.61e7
Flavour intensity [A.U.]
?
25.22
%
25.09
25.13
25.45
+
25.69
25.02
25.34
23.09 23.51 26.22
25.65 26.07
23.17 24.98
0 Time
23.00 23.25 23.50 23.75 24.00 24.25 24.50 24.75 25.00 25.25 25.50 25.75 26.00 26.25 26.50 26.75 27.00
1 min
solid
PP28 sweet
050726RR2 SIR of 5 Channels AP+
34.13 82.96
100
1.43e7
Flavour intensity [A.U.]
32.82
33.33
33.12
32.76
33.35
33.55
33.79
33.29 33.66
32.87 33.51 33.90
34.06
?
33.05
32.38 32.50
%
+
32.13 34.23
34.42
32.02
32.35
32.70
31.80 31.92
31.78 34.77
34.50
34.71
31.48
34.83 34.98
35.52
1 Time
31.00 31.50 32.00 32.50 33.00 33.50 34.00 34.50 35.00 35.50 36.00
4 min
Ruijschop et al., British Journal of Nutrition (2008), 99, 1140-1148 & thesis
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18. Flavour release affecting the
consumer’s (emotional) state of mind
•Same products: no difference in calorie content
and amount of product consumed.
30
delta satiation VAS rating (mm)
•Only difference is the amount of aroma
20 * * * (grams/ton)
Δ satiation
10
0
0 1
4 2
9 3
15 4
25 5
30 6
35 7
45
-10 Time (min)
aroma ad lib. food
-20 stimulation consumption difference in satiation!
•Significant
-30
* sign. effect type of aroma stimulation on Δ satiation VAS ratingtrial (min)
Time after start (p≤0.10)
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19. Flavour release determining Quality
• Low fat
• Loose taste quickly • High fat
• (High in) Natural sugars
Flavour intensity
• Creamy
• Highly satiating =>
low drinkability
Time
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20. Foods are cueing for…..
Timed-flavour release stimulates or
reduces food intake
Extended drinkability Extended satiation
Flavour intensity
e.g. clinical, elderly e.g. obesity, compliance
Our solution
Time (s)
What direction would you like to go?
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21. Optimising aroma, taste, texture and mouth feel
Low viscous protein foods
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22. Protein fortification of foods
• Simply increasing protein content of products leads to heat
texture and sensory defects
• Drinkables
• High protein content can lead to aggregation, gelation
and separation during processing and storage
• Sensory defects: sandy / inhomogeneous / gelled
• Semi-solids and solids
• Strong protein networks results in undesirable
texture
• Sensory defects: tough / rubbery / sticky / mealy /
crumbly
Tailored protein ingredients can provide the solution!
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23. Drinkables: modulating viscosity of caseinates
200
Control
180
Modified 1
160
Modified 2
Viscosity (mPa s)
140
Modified 3
120
100
80
60
40
20
0
0 5 10 15 20 25
Protein content (%, m/m)
• Caseinates can be easily tailored to provide readily dispersible ingredients
which give extremely low viscosity at very high concentration
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24. Digestibility of proteins
Predict gastrointestinal behavior of ingredients by
simulation of physiological digestion (NIZO
SIMPHYD)
Digestion tuned towards physiological conditions
In-line rheological measurements
Check for bioavailability of protein when
acidification dense or insoluble particles are prepared
10 Casein (Na+-caseinate) 5
Rate of appearance
Rate of Leu appearance
4
(µmol/kg/min)
whey
Viscosity (mPa.s)
3
Whey (WPI)
2
casein
1 1
0 20 40 60 80 100 120 140 160 180 200 0 60 120 180 240 300 360 420
Time (min)
Time (min)
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25. Products with health functionality
4
1
Building health End Concept
claims product Selection of
health concept
Testing
and ingredient
Choose
Strategy and
Technologies
Pilot-scale
production of
final product
Processing of
Product application
From raw material health
Preparation of
health ingredient 2
3 to consumer use ingredient
Preparation of
health products
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26. NIZO and industry
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next level
Rianne.Ruijschop@nizo.nl
Product Manager
Food Intake & Metabolism
Tel: + 31 318 659 645
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Technology for your success 26