Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants with Increased Cardiometabolic Risk

NCT06270901 | Completed

• 1 other identifier: BMEL: 2822EPS008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated.

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Keywords

postprandial metabolic events

Outcome Measures

Primary Outcomes (1)

• Parameters of lipid metabolism in blood

  Triglycerides (mg/dL)

  Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Secondary Outcomes (19)

• Parameters of lipid metabolism in blood

  Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

• Parameters of lipid metabolism in blood

  Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

• Parameters of lipid metabolism in blood

  Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

• Parameters of lipid metabolism in blood

  Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

• Parameters of glucose metabolism in blood

  Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)

Study Arms (4)

High Protein Planetary Health Diet

EXPERIMENTAL

High Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes)

Other: High Protein Planetary Health Diet

Low Protein Planetary Health Diet

EXPERIMENTAL

Low Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes)

Other: Low Protein Planetary Health Diet

High Protein Western Diet

EXPERIMENTAL

High Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin

Other: High Protein Western Diet

Low Protein Western Diet

EXPERIMENTAL

Low Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin

Other: Low Protein Western Diet

Interventions

High Protein Planetary Health Diet OTHER

Planetary Health Diet Meal with 62 g of protein primarily from plant origin

High Protein Planetary Health Diet

Low Protein Planetary Health Diet OTHER

Planetary Health Diet Meal with 36 g of protein primarily from plant origin

Low Protein Planetary Health Diet

High Protein Western Diet OTHER

Western Diet Meal with 62 g of protein primarily from animal origin

High Protein Western Diet

Low Protein Western Diet OTHER

Western Diet Meal with 36 g of protein primarily from animal origin

Low Protein Western Diet

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• Non-smoking
• BMI: 27 - 34,9 kg/m2
• Waist circumference (women ≥ 80 cm, men ≥ 94 cm)
• Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg
• At least one of the following criteria
• Fasting triglycerides in serum: ≥ 150 mg/dL
• Fasting HDL-Cholesterol in serum: women \< 50 mg/dl, men \< 40 mg/dL
• Fasting C-reactive protein in serum: ≥ 2 mg/L
• Fasting glucose in plasma: ≥ 100 mg/dL

You may not qualify if:

• food intolerances and allergies (especially to legumes)
• Smoking
• malabsorption syndromes
• thyroid diseases
• impaired renal function
• chronic liver disease
• heart failure
• myocardial infarction
• insulin-dependent diabetes mellitus
• chronic inflammatory diseases
• tumors
• anemia
• immunosuppression
• intake of supplements (e.g., fish oil)
• Participation in another study

Sponsors & Collaborators

• University of Bonn: lead
• Federal Ministry of Food and Agriculture (BMEL): collaborator
• Federal Office for Agriculture and Food (BLE): collaborator

Study Sites (1)

University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology

Bonn, North Rhine-Westphalia, 53115, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sarah Egert, Prof PhD

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 21, 2024
• Study Start: May 2, 2024
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)