Clinical trial NCT06626867: Effect of Dietary Fiber on Metabolic Syndrome, Gastrointestinal Function, Mood and Sleep Quality in Obese People
Official title: Effect of Dietary Fiber on Metabolic Syndrome, Gastrointestinal Function, Mood and Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hyperglycemia
Dyslipidemia
Obesity
Metabolic Syndrome
Keywords: prebiotic
POMS
PSQI
indigestible dextrin
dietary fiber
Lead sponsor: University of Taipei
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Metabolic syndrome includes hypertension(high blood pressure), hyperglycemia(high blood suger), dyslipidemia(abnormal blood lipid level) and obesity. The more items that meet metabolic syndrome, the higher the risk of cardiovascular disease and diabetes, and the higher the combined mortality. At present, research reports point out that the occurrence of metabolic syndrome is related to age, obesity, lifestyle and genetics.

The lack of sleep may reduce the diversity of intestinal flora, and conversely, if the diversity of intestinal flora can be increased, the quality of sleep may be improved. Dietary fiber can improve intestinal microflora and related indexes of metabolic syndrome.

Although recent studies have demonstrated that dietary fiber will affect obesity, mood and sleep, different kinds of dietary fiber will affect different strains and pro-duce different effects. The effect of resistant starch on metabolic syndrome, mood and sleep of obese people is not very clear. Therefore, the objective of this intervention trial was to evaluate the effects of the intake of resistant starch on sleep, mood, changes in body composition and biomarkers in metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Obese working popu-lation aged between 30 and 45;
* Body fat is more than 25% for male and more than 30% for female

Exclusion Criteria:

* Taking any medicines;
* Menopausal women;
* Pregnant woman

Primary outcomes:
measure: Body fat percentage
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Fasting glucose
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Mood disturbance(Questionnaires)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pittsburgh Sleep Quality Index(Questionnaires)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Biochemical Markers
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: High sensitivity C-reactive protein
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Total cholesterol
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Triglyceride
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Anthropometrics
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Laboratory of Exercise Biochemistry, Department of Sports Sciences, University of Taipei
Study officials:
References: