MoKaRi II Intervention Study

NCT05382533 | Completed

• 1 other identifier: H13-22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose \> 5.6 ≤ 7 mmol/l).

Conditions

Decreased Cardovascular Risk; Decreased Risk of Diabetes Mellitus Type II

Keywords

triacylglcerides, glucose, HbA1c, body weight

Outcome Measures

Primary Outcomes (2)

• Triacylglcerides, mmol/l (group A, B)

  Cardiovascular risk factor

  Change from baseline after 10 weeks

• Fasting glucose, mmol/l (group C, D)

  Diabetes risk factor

  Change from baseline after 10 weeks

Secondary Outcomes (28)

• Total cholesterol (mmol/l)

  Change from baseline after 10 weeks

• HDL cholesterol (mmol/l)

  Change from baseline after 10 weeks

• LDL cholesterol (mmol/l)

  Change from baseline after 10 weeks

• Systolic pressure (mm Hg)

  Change from baseline after 10 weeks

• Diastolic pressure (mm Hg)

  Change from baseline after 10 weeks

Other Outcomes (4)

• Creatinine (mmol/l)

  Change from baseline after 10 weeks

• Albumine (mg/l)

  Change from baseline after 10 weeks

• Selenium (µmol/24 h)

  Change from baseline after 10 weeks

Study Arms (4)

Hypertriglyceridemia intervention (group A)

EXPERIMENTAL

* Carbohydrates: ≤ 50 en% (sucrose + glucose + fructose ≤ 10 en%, where sucrose ≤ 5 en% and fructose ≤ 20 g/d) * Fat: 30-35 En% * Protein: 20 En% * marine n3 PUFA (EPA/DHA): ≥ 4000 mg/d (10 g fish oil)

Dietary Supplement: Menu plans

Hypertriglyceridemia control (group B)

NO INTERVENTION

no menu plans, no study foods

Prediabetes intervention (group C)

EXPERIMENTAL

* Carbohydrates: 40 ± 2 En% * Sucrose + glucose + fructose ≤ 10 En% * Free sugars \< 5% of daily energy * Fat: 40 ± 2% * Protein: 20 ± 2 En% * n3 PUFA: ≥ 500 mg/d

Dietary Supplement: Menu plans

Prediabetes control (group D)

NO INTERVENTION

no menu plans, no study foods

Interventions

Menu plans DIETARY_SUPPLEMENT

The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (plant oils, nuts mixture etc.) over the study period of 10 weeks.

Hypertriglyceridemia intervention (group A); Prediabetes intervention (group C)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation with documented consent
• Willingness and ability to adhere to study protocol
• Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years
• BMI: ≥ 20 ≤ 40 kg/m2
• No or moderate alcohol consumption (≤ 2 glasses/week)
• non-smoker (if possible)
• Group A, B: triglycerides: \> 1.5 mmol/l
• Group C, D: Fasting glucose: ≥ 5.6 ≤ 7 mmol/L

You may not qualify if:

• Concomitant diseases:
• Hypercholesterolemia (genetic defect / familial predisposition)
• Diabetes mellitus
• Thyroid dysfunction (hyper- or hypothyroidism)
• Food intolerances/allergies to ingredients in the study foods
• Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections
• Dietary supplements: especially n-3 fatty acids, vitamin E
• Extremely high physical activity (daily)
• Alcohol abuse (daily)
• (smokers) \[if there are not enough subjects available, at least 7 smokers should be included so that a statistical analysis is possible\]
• Uncontrolled organic diseases
• Alcohol, medication or drug abuse
• Participation in other observational clinical studies during or 4 wk. before starting this study
• Severe behavioral, emotional, or psychiatric problems that the investigator determined would result in non-compliance
• Pregnancy, lactation and unsafe contraception

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Institute of Nutritional Sciences

Jena, Thuringia, 07743, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Body Weight

Interventions

Menu Planning

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food Services; Food Industry; Industry; Technology, Industry, and Agriculture; Food Service, Hospital; Dietary Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christine A Dawczynski, PhD

  Friedrich Schiller University Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: parallel design

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: May 30, 2022
• Primary Completion: August 31, 2022
• Study Completion: December 14, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

DE (1)