The aim of the study is to test the synergistic effect of resistant starch, capsaicin, and protein on energy expenditure, substrate oxidation, and satiety. Furthermore, to investigate whether an 80% energy requirement high-protein diet containing…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is:
No differences in satiety and thermogenesis between the 80% energy requirement
high-protein diet containing resistant starch and capsaicin, and the 100%
energy requirement normal-protein diet without resistant starch and capsaicin.
Secondary outcome
The secondary endpoints of the study are significant differences in satiety and
thermogenesis between:
- The 100% energy requirement high-protein diet containing resistant starch and
capsaicin, and the 100% energy requirement normal-protein diet without
resistant starch and capsaicin.
- The 80% energy requirement high-protein diet containing resistant starch and
capsaicin, and the 80% energy requirement normal-protein diet without resistant
starch and capsaicin.
- The 80% energy requirement high-protein diet containing resistant starch and
capsaicin, and the 100% energy requirement high-protein diet containing
resistant starch and capsaicin.
- The 80% energy requirement normal-protein diet without resistant starch and
capsaicin, and the 100% energy requirement normal-protein diet without
resistant starch and capsaicin.
Background summary
It is known that the replacement of digestible starch with resistant starch
(RS) may reduce post-prandial glycemia and insulinemia, and may increase
post-prandial satiety.
Furthermore, it is known that high-protein foods are more satiating and have a
higher thermogenic effect than normal protein foods, over the short as well as
over the long-term. Third, addition of capsaicin to the diet has been shown to
increase satiety and thermogenesis. However, the synergistic effects of these
food ingredients have never been studied. With respect to the treatment of
obesity, it is of interest to investigate whether these effects can also be
used during energy restriction, in which it is expected that satiety and
thermogenesis remain at the original level.
Study objective
The aim of the study is to test the synergistic effect of resistant starch,
capsaicin, and protein on energy expenditure, substrate oxidation, and satiety.
Furthermore, to investigate whether an 80% energy requirement high-protein diet
containing resistant starch and capsaicin reaches the same satiety and
thermogenesis level as a 100% energy requirement normal-protein diet without
resistant starch and capsaicin.
Study design
The study will have a randomized 4 arms crossover design. Randomization takes
place using a computerized randomization program. To investigate whether there
is no difference between 80% of the high-protein diet with resistant starch and
capsaicin and 100% of the normal diet, these diets need to be compared among
themselves when they both consist of 80% or 100% of the energy requirement.
That is why 4 conditions have to be executed.
Intervention
The tested diets during the four test-sessions are: i) a 100% energy
requirement high-protein diet containing resistant starch and capsaicin; ii) a
80% energy requirement high-protein diet containing resistant starch and
capsaicin; iii) a 100% energy requirement normal-protein diet
without resistant starch and capsaicin; iv) a 80% energy requirement
normal-protein diet without resistant starch and capsaici
Study burden and risks
In total the time spent on the respiration chamber study will be 4 x 36 = 144
hours test.
All the food items and investigational product used in this study are
commercially available. Consumption of these items does not include any risks..
Furthermore, no specific risks with respect to the measurements are known.
Postbus 616
6200 MD Maastricht
Nederland
Postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Healthy, non-smoking, non-dieting male subjects with a BMI between 22-33 kg/m2 and aged between 20-60 years.
Exclusion criteria
Smoking, dieting, use of medication
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15912.068.07 |