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Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet.

Preventive medicine
August 1, 1999
A S Nicholson et al. (6 authors)
Clinical TrialJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

To determine if a low-fat, vegetarian (vegan) diet improves glycemic and lipid control in patients with non-insulin-dependent diabetes (NIDDM) without exercise or other lifestyle changes.

Results Summary

The vegan diet group showed a 28% mean reduction in fasting serum glucose and 7.2 kg weight loss, significantly greater than the control group. Medication use was reduced or discontinued in the vegan group, but HDL levels fell more sharply compared to controls.

Population

Patients with non-insulin-dependent diabetes (NIDDM).

Effective Dosage

Not specified (low-fat, vegetarian diet).

Duration

12 weeks.

Interactions

None mentioned.

Extracted Claims (11)
InterventionDirectionEndpointPopulationDosageImpactClaim #
low-fat vegan diet
decrease
fasting serum glucose
patients with non-insulin-dependent diabetes (NIDDM)
28% mean reduction (from 10.7 to 7.75 mmol/L)
significantly greater reduction
#1
low-fat vegan diet
decrease
body weight
patients with non-insulin-dependent diabetes (NIDDM)
7.2 kg
greater weight loss
#2
low-fat vegan diet
decrease
medication use (oral hypoglycemic agents)
patients with non-insulin-dependent diabetes (NIDDM)
discontinued in one and reduced in three of six subjects
reduced
#3
low-fat vegan diet
decrease
insulin use
patients with non-insulin-dependent diabetes (NIDDM)
reduced in both patients on insulin
reduced
#4
low-fat vegan diet
no change
serum cholesterol
patients with non-insulin-dependent diabetes (NIDDM)
-
did not reach statistical significance
#5
low-fat vegan diet
no change
24-h microalbuminuria
patients with non-insulin-dependent diabetes (NIDDM)
-
did not reach statistical significance
#6
low-fat vegan diet
decrease
high-density lipoprotein concentration
patients with non-insulin-dependent diabetes (NIDDM)
0.20 mmol/L
fell more sharply
#7
conventional low-fat diet
decrease
fasting serum glucose
patients with non-insulin-dependent diabetes (NIDDM)
12% decrease (from 9.86 to 8.64 mmol/L)
decrease
#8
conventional low-fat diet
decrease
body weight
patients with non-insulin-dependent diabetes (NIDDM)
3.8 kg
weight loss
#9
conventional low-fat diet
no change
medication use
patients with non-insulin-dependent diabetes (NIDDM)
no patient reduced medication use
no reduction
#10
conventional low-fat diet
decrease
high-density lipoprotein concentration
patients with non-insulin-dependent diabetes (NIDDM)
0.02 mmol/L
fell less sharply
#11
Abstract

OBJECTIVE: To investigate whether glycemic and lipid control in patients with non-insulin-dependent diabetes (NIDDM) can be significantly improved using a low-fat, vegetarian (vegan) diet in the absence of recommendations regarding exercise or other lifestyle changes. METHODS: Eleven subjects with NIDDM recruited from the Georgetown University Medical Center or the local community were randomly assigned to a low-fat vegan diet (seven subjects) or a conventional low-fat diet (four subjects). Two additional subjects assigned to the control group failed to complete the study. The diets were not designed to be isocaloric. Fasting serum glucose, body weight, medication use, and blood pressure were assessed at baseline and biweekly thereafter for 12 weeks. Serum lipids, glycosylated hemoglobin, urinary albumin, and dietary macronutrients were assessed at baseline and 12 weeks. RESULTS: Although the sample was intentionally small in accordance with the pilot study design, the 28% mean reduction in fasting serum glucose of the experimental group, from 10.7 to 7.75 mmol/L (195 to 141 mg/dl), was significantly greater than the 12% decrease, from 9.86 to 8.64 mmol/L (179 to 157 mg/dl), for the control group (P < 0.05). The mean weight loss was 7.2 kg in the experimental group, compared to 3. 8 kg for the control group (P < 0.005). Of six experimental group subjects on oral hypoglycemic agents, medication use was discontinued in one and reduced in three. Insulin was reduced in both experimental group patients on insulin. No patient in the control group reduced medication use. Differences between the diet groups in the reductions of serum cholesterol and 24-h microalbuminuria did not reach statistical significance; however, high-density lipoprotein concentration fell more sharply (0.20 mmol/L) in the experimental group than in the control group (0.02 mmol/L) (P < 0.05). CONCLUSION: The use of a low-fat, vegetarian diet in patients with NIDDM was associated with significant reductions in fasting serum glucose concentration and body weight in the absence of recommendations for exercise. A larger study is needed for confirmation.

Medical Subject Headings (MeSH)
AdultAgedBlood GlucoseBlood PressureBody WeightDiabetes Mellitus, Type 2Diet, Fat-RestrictedDiet, VegetarianEnergy IntakeEnergy MetabolismFastingFemaleGlycated HemoglobinHumansLipidsMaleMiddle AgedMultivariate AnalysisPilot Projects
Study Links
Quality Scores
Safety85
Efficacy80/10
Quality70/10
Citation Metrics
Total Citations121
Citations/Year4.7
Relative Citation Ratio2.92
NIH Percentile84.4%
Research Impact Scores
APT Score0.95
Weight Score0.63
Normalized Score0.80
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