Food Based Intervention Rich in Plant Components to Improve Metabolic Health in Prediabetics (FBIP) Study

NCT04745702 | Unknown

• 1 other identifier: 2019/00997
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The estimated prevalence of type 2 diabetes and prediabetes in Singapore will be approximately 20% and 25% respectively by the year 2035. Therefore, effective population based interventions are urgently warranted to halt this burden. Lifestyle intervention is the cornerstone of diabetes prevention and even remission. For example, dietary patterns such as the Mediterranean diet, Dietary Approaches to Stop Hypertension (DASH) diet etc. have all been shown to reduce risk of type 2 diabetes incidence. Therefore, given the successful utility of various dietary patterns, this randomized controlled trial will investigate the effectiveness of a food based dietary intervention, within an Asian dietary context, using legumes, low glycemic index (GI) starches (i.e., rice, noodles etc.), healthier vegetable oil blend as well as herbs and spices to improve various markers metabolic health, including glucose homeostasis in individuals with prediabetes.

Conditions

Diabetes

Keywords

Pre-diabetes; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• HbA1c

  mmol/mol (%)

  16 weeks

• Fasting glucose

  mmol/L

  16 weeks

• Fasting insulin

  pmol/L

  16 weeks

• Oral Glucose Tolerance Test

  mmol/L

  16 weeks

Secondary Outcomes (7)

• Blood Lipid Profile (HDL, LDL, Total Cholesterol, Triglyceride)

  16 weeks (from first to final measurement visits), measured every 4 weeks

• Fructosamine

  16 weeks (from first to final measurement visits), measured every 4 weeks

• Plasma Adiponectin

  16 weeks (from first to final measurement visits), measured every 4 weeks

• Oxidised LDL

  16 weeks (from first to final measurement visits), measured every 4 weeks

• C-Reactive Protein

  16 weeks (from first to final measurement visits), measured every 8 weeks

Study Arms (2)

Low-Calorie Control Group

OTHER

The control group will receive for 2 calorie-restricted balanced meals per day, consisting of a portion of meat, a portion of vegetables, a portion of medium to high GI carbohydrates and prepared with refined corn oil. The control meals will be devoid of any whole legumes and will contain minimal amounts of spices. The third meal of the day and any additional snacks will be left to the free choice of the participants with calorie advice provided by study dietitian. Calorie restriction aims to reduce weight of participants by \~5%.

Combination Product: Low Calorie Balanced Meals

Low-Calorie Treatment Group

ACTIVE COMPARATOR

The treatment group will receive for 2 calorie-restricted (isocaloric with control group) meals per day containing 100 g cooked whole legumes (amounting to a total of 200 g cooked legumes, approximately 1 cup of cooked legumes)and/or certain meat analogues (textured vegetable \[soy\] proteins), and/or a portion of vegetables, low GI, wholegrain carbohydrates for their starch sources (rice/noodles/pasta), added spices (dried spice powder) at dietary and culinary acceptable doses and blended vegetable oil. The third meal of the day and any additional snacks will be left to the free choice of the participants with calorie advice provided by study dietitian. Calorie restriction aims to reduce weight of participants by \~5%.

Combination Product: Low Calorie Meals Rich in Plant Components

Interventions

Low Calorie Meals Rich in Plant Components COMBINATION_PRODUCT

Twice a day reduced calorie frozen ready meals (rich in plant components) to substitute participants' two main meals/day consecutively for a period of 16 weeks.

Low-Calorie Treatment Group

Low Calorie Balanced Meals COMBINATION_PRODUCT

Twice a day reduced calorie frozen ready meals (balanced composition) to substitute participants' two main meals/day consecutively for a period of 16 weeks.

Low-Calorie Control Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese Male or Female• Age between 45-75 years
• Body mass index 19.5-32.0 kg/m2
• Deemed to be prediabetic based on meeting any 1 of 3 following criteria:1. Fasting blood glucose \>5.5 mmol/l and \<7.0 mmol/l2. Oral glucose tolerance test (OGTT) level \>/=7.8 mmol/l and \</=11.0 mmol/l3. Haemoglobin A1c (HbA1c) level \>/=5.7 and \</=6.4%.

You may not qualify if:

• Smoking
• Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
• Following special diets or having intentional dietary restrictions (e.g, vegetarians/vegans)
• Not willing to adhere to diet modification as in the study protocol
• Not willing to stop any strenuous activity during or within 24 hours of test days (for those actively participating in sports at the competitive and/or endurance levels)
• Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
• Having alcohol consumption on \> 4 days per week with ≥ 6 alcoholic drinks per week
• Having sustained elevation of blood pressure (\>160/95 mm Hg)
• Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders
• Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions
• Diabetic
• Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections
• Having any prescription medication or any other alternative medicines or supplements which may interfere with study measurements in the in the opinion of the study investigators
• Having antibiotics or suffering from diarrhea within the last 3 months
• Having donated blood within 4 weeks of study participation

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (1)

• Wu X, Tjahyo AS, Volchanskaya VSB, Wong LH, Lai X, Yong YN, Osman F, Tay SL, Govindharajulu P, Ponnalagu S, Tso R, Teo HS, Khoo K, Fan H, Goh CC, Yap CPL, Leow MK, Henry CJ, Haldar S, Lim KJ. A legume-enriched diet improves metabolic health in prediabetes mediated through gut microbiome: a randomized controlled trial. Nat Commun. 2025 Jan 22;16(1):942. doi: 10.1038/s41467-025-56084-6.

  PMID: 39843443 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 9, 2021
• Study Start: November 2, 2020
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)