mild dyslipidemia?slightly elevated triglycerides?mildly elevated cholesterol?irregular bowel habits?mild constipation
Conditions
Interventions
Vitality Kernel Flaxseed Puree Group (Single-Arm):Intervention: Oral administration of Vitality Kernel Flaxseed Puree
Sponsors
Shanghai Fengxian District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old (including borderline values), gender is not limited; 2. Body mass index (BMI) between 18.5 and 30 kg/m2 (including borderline values); 3. Presence of mild to moderate dyslipidemia, defined as the presence of any of the following laboratory parameters in the fasting state (according to the ‘Chinese Guidelines for the Management of Blood Lipids (Primary Version 2024)’): Total Cholesterol (TC): >=5.2 mmol/L and =3.4 mmol/L and =3.4 mmol/L and =3.4 mmol/L and =1.7 mmol/L and =3 times/day; Abnormal faecal characteristics (type 1-2 or 6-7 on the Bristol Stool Scale) 7); Irregular bowel movements or with mild defecation difficulties (PAC-SYM scale score is mildly abnormal); Stable lifestyle, no use of medications or supplements that may affect lipid metabolism or intestinal function in the last 4 weeks, including, but not limited to: 5. Lipid-regulating medications (e.g., statins, fibrates, etc.); Laxatives, gastrointestinal stimulant medications; Probiotics, prebiotics, synbiotics and dietary fibre supplements, etc.; 6. Voluntarily participate in this study, sign the informed consent form, and be able to comply with the requirements of the study protocol and cooperate with the completion of all examinations and follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Individuals with severe dyslipidemia or requiring pharmacological treatment, defined as: Total cholesterol (TC) >=7.0 mmol/L; Low-density lipoprotein cholesterol (LDL-C) >=5.0 mmol/L; Triglycerides (TG) >=2.3 mmol/L; 2.History of or current serious cardiovascular, hepatic, renal, gastrointestinal, or endocrine/metabolic diseases, including but not limited to diabetes mellitus and thyroid dysfunction; 3.Known allergy to flaxseed or any components of the study product; 4.Pregnant or breastfeeding women, or women planning pregnancy during the study period; 5.Any conditions, surgeries, or treatments that may interfere with the assessment of blood lipids or gastrointestinal function; 6.Individuals with poor compliance or inability to adhere to study procedures, including unstable lifestyle patterns or unwillingness to follow study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in blood lipid levels, including: Total cholesterol (TC) Triglycerides (TG) Low-density lipoprotein cholesterol (LDL-C) High-density lipoprotein cholesterol (HDL-C);Improvement in gastrointestinal function, assessed by: Bowel movement frequency (times per week) Stool consistency (Bristol Stool Scale) Degree of defecation difficulty (PAC-SYM questionnaire); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary intake, assessed using a dietary survey questionnaire.;Self-reported quality of life and digestive comfort, assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire;; | — |
Countries
China
Contacts
Public ContactWangman
Shanghai Fengxian District Central Hospital
Outcome results
None listed