Effects of Whole Fruit on Blood Sugar in People With Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarvard School of Public Health (HSPH)
About this trial
This study will determine the effects of consuming whole fruit on blood sugar control, liver fat, and cardiovascular health in adults with type 2 diabetes who are not treated with insulin.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Diagnosed with type 2 diabetes
HbA1c between 6.5-12.0%
Fasting C-peptide level ≥0.5 ng/ml, indicating the patient does not have beta-cell failure, as measured at screening
Disqualifiers
On insulin
Evidence of latent autoimmune diabetes (LADA) or maturity-onset diabetes of the young (MODY)
Estimated glomerular filtration rate (eGFR) <45 ml/min per 1.73 m²
Heart attack in the past 6 months or severe/unstable heart failure
Trial design
Design model
Single group
Treatments tested in this trial
Whole Fruit
Other interventionParticipants will consume a large amount of whole fruit for 17 weeks. During the first 6.5 weeks, participants will gradually increase the amount of whole fruit they eat by 5% every 5 days. Once they reach 50% of their calories as whole fruit, they will continue to eat 50% fruit for the remaining 10.5 weeks of the study. This is a controlled feeding study, so participants will consume fruit prepared in a metabolic kitchen. The fruit will consist of fresh fruit, dried fruit, and frozen fruit blended into smoothies. To demonstrate compliance, participants will video-record themselves eating the provided fruit. All participants will receive the same dietary intervention. Participants will otherwise continue their usual diet and lifestyle habits.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Whole FruitExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean 24-hour Glucose Levels
Average 24-hour interstitial glucose levels (mg/dl), as measured by continuous glucose monitoring (CGM). If needed, data will be adjusted for any changes in antihyperglycemic medication use, using the medication effect score (MES).
Time frame
Change from baseline to week 172
Mean 3-hour Glucose Levels
Mean glucose (mg/dl) during a 3-hour oral glucose tolerance test (OGTT)
Time frame
Change from baseline to week 173
Mean 3-hour Insulin
Mean insulin (mU/l) during a 3-hour OGTT
Time frame
Change from baseline to week 174
Mean 3-hour C-Peptide
Mean C-Peptide (ng/ml) during a 3-hour OGTT
Time frame
Change from baseline to week 17Secondary outcomes
1
Intrahepatic Lipid (Liver Fat)
Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI)
Time frame
Change from baseline to week 172
Body Weight
kg
Time frame
Change from baseline to week 173
Systolic and Diastolic Blood Pressure
mm Hg
Time frame
Change from baseline to week 174
Heart Rate
beats per minute
Time frame
Change from baseline to week 17Sponsors and contacts
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Source ClinicalTrials.gov
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